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A randomized controlled trial of an intervention for infants’ behavioral sleep problems Hall, Wendy A; Hutton, Eileen; Brant, Rollin F; Collet, Jean P; Gregg, Kathy; Saunders, Roy; Ipsiroglu, Osman; Gafni, Amiram; Triolet, Kathy; Tse, Lillian; Bhagat, Radhika; Wooldridge, Joanne Nov 13, 2015

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RESEARCH ARTICLE Open AccessA randomized controlled trial of anintervention for infants’ behavioral sleepproblemsWendy A. Hall1*, Eileen Hutton2, Rollin F. Brant3, Jean Paul Collet4, Kathy Gregg5, Roy Saunders6, Osman Ipsiroglu7,Amiram Gafni8, Kathy Triolet9, Lillian Tse10, Radhika Bhagat11 and Joanne Wooldridge12AbstractBackground: Infant behavioral sleep problems are common, with potential negative consequences. We conducteda randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teachingsession and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes orparent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue,sleep, and parent cognitions about infant sleep.Methods: Two hundred thirty five families of six-to-eight month-old infants were randomly allocated tointervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety.Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based onactigraphy and sleep diaries over six days. Secondary outcomes were derived from the MultidimensionalAssessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index,and Maternal (parental) Cognitions about Infant Sleep Questionnaire.Results: One hundred eight intervention and 107 control families provided six-week follow-up information withcomplete actigraphy data for 96 in each group: 96.9 % of intervention and 97.9 % of control infants had anaverage of 2 or more nightly wakes, a risk difference of −0.2 % (95 % CI: −1.32, 0.91). 4 % of intervention and14 % of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of −10 %(CI: 0.11, 0.84-16.8 to −2.2). Relative to controls, intervention parents reported improved baseline-adjusted parentaldepression (CI: −3.7 to −0.4), fatigue (CI: −5.74 to −1.68), sleep quality (CI: −1.5 to −0.2), and sleep cognitions:doubts (CI: −2.0 to −0.6), feeding (CI: − 2.1 to - 0.7), anger (CI: − 1.8 to - 0.4) and setting limits (CI: −3.5 to −1.5).Conclusions: The intervention improved caregivers' assessments of infant sleep problem severity and parentaldepression, fatigue, sleep, and sleep cognitions compared with controls.Trial registration: ISRCTN42169337, NCT00877162Keywords: Randomized controlled trial, Multi-component intervention, Behavioral sleep problems, Infants,Actigraphy, Diaries, Parents* Correspondence: wendy.hall@ubc.ca1University of British Columbia School of Nursing, T 201, 2211 Wesbrook Mall,Vancouver, BC V6T 2B5, CanadaFull list of author information is available at the end of the article© 2015 Hall et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Hall et al. BMC Pediatrics  (2015) 15:181 DOI 10.1186/s12887-015-0492-7BackgroundBehavioral sleep problems (BSP) affect 20 to 30 % ofinfants and often persist from infancy to later childhood[1, 2]. Predominant problems identified by parents areinfants’ difficulties in falling asleep and staying asleep[2], which create fragmented sleep and/or short sleepduration. Adequate sleep duration is associated with in-creased infant adaptability and rhythmicity [3], whilenight waking with crying has been associated withgreater stress reactivity, for example, during inoculations[4]. Young children’s BSPs have been linked to hyperactiv-ity, and cognitive, emotional, and behavioral difficulties,after controlling for maternal depressive symptoms [5–9].Infants’ BSPs have been associated with maternal depres-sive symptoms, serious psychological distress, poor gen-eral health, and feelings of incompetence [10–12]. Fathers,although rarely studied, have reported poorer generalhealth and more psychological stress when their infantshave BSPs [11].A review of over 50 published treatment studies forchildren’s BSPs indicated behavioral interventions wereefficacious, with over 80 % of children treated demon-strating clinically significant improvement that wasmaintained for 3 to 6 months [13]. Reviewers recom-mended future studies test group interventions and in-corporate actigraphy as an objective sleep measure,measures of parental depression, and combined objectiveand subjective (parental diary) sleep measures [13]. Ourbefore-after design pilot study of a cognitive-behavioralgroup intervention (CBGI) for seven groups of five par-ents (n = 35) with 6-to-12-month-olds experiencing BSPsdemonstrated significantly reduced numbers of nightwakes and longer night sleep time, by actigraphy, postintervention [14], as well as significantly improved par-ental mood, sleep quality, fatigue, and cognitions aboutinfant sleep [15]. The CBGI involved a two-hour teach-ing session and two weeks of telephone support. Parentsin that study reported that participating in a groupteaching session with other parents whose children hadsleep problems ‘normalized’ what they were experiencingand helped them regard their children’s sleep problemsas common and amenable to change. Being part of thegroup and receiving telephone support calls increasedtheir confidence to manage infant sleep [16].In Canada, public health units are located in communi-ties and deliver population-based programs and servicesthat protect and promote Canadian’s health and focus onprimary prevention [17]. Services vary by province andhealth authorities. In Vancouver, British Columbia, publichealth nurses have brief contact with healthy infants atbirth, with no further formal contact unless families attendimmunization clinics or postnatal drop-ins. Postnataldrop-ins offer families information about children’s nutri-tion and safety, adjusting to parenthood, and sleep [18].Sleep sessions have provided general information aboutinfant sleep and overviews of potential approaches tomanaging infant sleep. Our randomized controlled trialaimed to determine the efficacy of a cognitive-behavioralgroup intervention, offered through public health nurses.Our hypotheses were: fewer intervention group infantswould have ≥2 night wakes or fewer intervention groupparents would identify infants as having severe sleep prob-lems at 6 weeks post-teaching session than control groupparents. Secondary outcomes, at 6 weeks post-teachingsession, were that parental mood, sleep quality, fatigue,and cognitions about infant sleep would improve signifi-cantly more in the intervention group and interventiongroup infants would have significantly longer longest sleepperiods (actigraphy) and significantly fewer night wakes(actigraphy and sleep diary) than control group infants.MethodsEthics statementThe University of British Columbia (H09-00757) andVancouver Coastal Health (#CS09-076) Research EthicsBoards approved the trial. Informed consent was providedby all participants, after obtaining written and oral infor-mation about the study. The consent form included thestatement that the parents consented to their infant’s par-ticipation in the study. A data and safety monitoring boardmet annually to monitor adverse events. None occurred.No changes were made to the trial after commencement.The trial was registered on the following sites: ISRCTN,42169337, url: http://www.isrctn.com/ NCT00877162,url: https://clinicaltrials.gov/.Participants and proceduresPosters, media announcements, online classifieds (Kijijiand Craigslist), and Facebook were used to disseminateinformation to families in the Greater Vancouver areaabout the trial. Posters were placed in coffee shops, li-braries, community centres, and public health units. In-terested families contacted the study coordinator to askquestions and be screened for inclusion. Families weretold that we were testing an intervention to see whetherit would improve infants’ BSP and that they would beassigned to receive the intervention or a control sessionon infant safety.Eligible families were biological or adoptive, able toread and speak English, had access to a telephone, andconstituted a single or two-parent family. Both parentsin a two-parent family had to commit to participation inthe study. Eligible infants had no identified health prob-lems, were between corrected ages of five-point-five andeight months at recruitment, and were either sex. Thestudy coordinator used a list of questions to determinewhether infants met the inclusion criterion of demon-strating moderate BSP, as defined by the AmericanHall et al. BMC Pediatrics  (2015) 15:181 Page 2 of 12Association of Sleep Medicine clinical Classification ofSleep Onset Association disorder (waking two or moretimes per night at least five nights per week) [19]. Parentswho reported depression or sleep problem diagnoses ortreatment, worked permanent night shifts, or lived outsidethe study catchment area (Greater Vancouver) were ex-cluded. We excluded infants with organic causes of sleepdisruption, developmental disability, or chronic neuro-logical or respiratory conditions.At baseline, research assistants delivered questionnaires(demographic, depression, sleep quality, sleep cognitions,and fatigue measures), actigraphs, and study-designedsleep diaries to families. Research assistants (blinded togroup assignment) demonstrated how to apply actigraphsand complete the record of actigraph application and re-moval and sleep diaries. They also provided an informa-tion sheet that explained when to begin and end collectingactigraphic and diary data simultaneously. The researchassistants left the questionnaires with the parents forself-administration. Baseline actigraphic and diarymeasurements occurred over 6 days. The first familieswere enrolled in September 2009; the final outcome as-sessment was completed in September 2011.After the study coordinator enrolled families and re-search assistants obtained consent and baseline measure-ments, families were randomly allocated in sequentialblocks of 10 to intervention (sleep) and control groups(safety) at each site (Fig. 1). The sequential blocks were toensure that families were equally distributed by group des-ignation and geographic area (4 health unit sites). A datamanager used a computerized secure software platform torandomly assign families to groups.Families attended a teaching session at one of 4 healthunits and received follow-up phone calls from the nursewho taught the session. Families from outside the healthunit geographical boundaries attended a teaching sessionat the health unit closest to their geographical location.The same follow-up measurements (over 6 days) wereconducted 6 weeks after the teaching intervention. Atotal of 25 intervention and control sessions occurred atFig. 1 Participant Flowchart (CONSORT)Hall et al. BMC Pediatrics  (2015) 15:181 Page 3 of 12roughly five-week intervals. After six-week data collec-tion, the sleep group received the infant safety infor-mation and the safety group received the infant sleepinformation. We provided the safety group with infantsleep information because the literature indicates infants’BSPs have negative outcomes for parents [10–12] andinfants [4] and we regarded it as unethical to withhold apotentially useful intervention in the absence of anystandard accessible treatment for infant BSP.InterventionOur intervention aimed to improve a BSP at an agewhen infants are developmentally capable of sustaining along self-regulated sleep period for, on average, 10 h[20]. We sought to change families’ cognitions and be-haviors to promote infant self-soothing and targeted ourintervention to both parents because both have affectedinfant sleep [21]. Parental cognitions are defined as be-liefs, expectations, and interpretations of children’s sleepbehavior which are viewed as influencing parent-infantinteractions and infant sleep patterns [22, 23]. Becausepublic health nurses frequently encounter families ex-periencing infant BSP we trained them to deliver thesleep intervention. Nurses also delivered the safety con-trol sessions. The principal investigator created the ma-terials for the teaching sessions and phone calls. Totaltreatment duration was 3 weeks: one 2-h teaching ses-sion followed by bi-weekly telephone calls for 2 weeks.The nurses who delivered the teaching sessions calledthe parent leading the intervention/control twice a weekfor 2 weeks to reinforce concepts and provide support.The intervention and control groups were asked the samequestions during the telephone calls: How were parentsmanaging; what strategies were they using; what were theeffects of their strategies on their infants and the parents;and what, if any, difficulties were they experiencing?Sleep interventionGroups of families received information about normalinfant sleep, effects of inadequate sleep for infants andparents, setting limits around infant sleep, the import-ance of daytime and sleep routines, and negative sleepassociations (Table 1). The intervention introduced be-haviors that families could use to promote infant self-soothing, in particular, controlled comforting, with twoto 10 min taken to console the infant and then leavingthe room for increments of two minutes up to 10 minintervals [24]. Families observed a recording of an infantin light and deep sleep (so they could see an infantvocalizing and opening her eyes while asleep) and aninterview with parents living with a child with a sleepproblem. The video was intended to point to longer termsleep problems when interventions were not initiated ininfancy. Families also received handouts of the scriptedpower point presentation, weekly sleep-wake-feed-playcharts (routines), and controlled comforting charts. Chartsenabled them to track their use of techniques and anychanges in their infants’ sleep.Safety controlGroups of families learned about infant safety risks, e.g.,shaken baby syndrome, choking, falls, sleep positioning,motor vehicle travel, pacifiers, suffocation, strangulation,poisoning, and burns, as well as factors influencing risksand strategies for prevention. Co-sleeping as a risk to in-fant safety was not discussed. Families received a hand-out of the scripted power point presentation, whichincluded a safety checklist. Nurses answered questionsthat were raised during the teaching session, e.g., recallsfor cribs or infant car seats.Training and intervention fidelityTen public health nurses, with five or more years ofexperience, and three registered nurses, with two or moreyears of experience in community settings, were separatelytrained during eight hour sessions for the sleep interven-tion (Table 2) and safety control. Role plays for deliveringTable 1 Topics addressed during teaching sessionsInformation about infants’ patterns (cognitions)▪ Infants have developmental shifts▪ Infant feeding requirements at night▪ Sleep-wake-feed-play and usual sleep patterns and typicalsleep progression▪ Infant behaviors associated with sleep types and tiredness cuesNegative Sleep Associations (cognitions)▪ Movement to sleep▪ Feeding to sleep▪ Putting an infant to bed asleep▪ Reactive co-sleepingUnrealistic expectations about sleep (cognitions)▪ Less napping and late bedtimes will promote night sleep▪ Nap and bedtimes do not matter▪ Parents’ approaches can differEffects of sleep loss on infants and parents (cognitions)▪ Associations between behavioral sleep problems and infantgrowth and development▪ Associations between sleep disturbance, parental mood,confidence, and problem-solvingStrategies to Reduce Night Waking (behaviors)▪ Daytime, bedtime, and naptime routines▪ Minimal stimulation before bed▪ Feeding 20 min prior to settling▪ Controlled comforting with periodic checking▪ Avoid reactive co-sleepingHall et al. BMC Pediatrics  (2015) 15:181 Page 4 of 12the teaching session and follow-up telephone calls wereincluded. Nurses received training manuals, documentswith frequently asked questions and answers about sleepand safety, standard scripted formats for the teachingsessions and follow-up calls, and a PowerPoint Module.Public health nurses received videotaped materials. Adhoc calls to participants by nurses were prohibited.Nurses video-recorded their teaching sessions andaudio-recorded their follow-up calls for review. Theprincipal investigator reviewed 100 % of the initial train-ing sessions and follow-up calls to provide support andreinforce standardization. Thereafter, the principal inves-tigator randomly reviewed 50 % of videos and 10 % ofthe follow-up call recordings. In 90 % of teaching ses-sions and 80 % of calls, nurses followed protocols. Theprincipal investigator worked with nurses omitting pre-scribed behaviors to incorporate them. The informationfrom the phone calls is not included in this report.Outcome measuresOur primary outcome was a composite measure ofsignificant sleep disturbance consisting of either parentreporting a severe sleep problem or mean actigraphicwakes of ≥ 2 per night averaged over 5 nights. Evidencethat the intervention was successful would be signifi-cantly smaller proportions of parents reporting severeinfant sleep problems (four-point [no problem, mild,moderate, severe] measure) or significantly smaller pro-portions of infants with mean actigraphic wakes of ≥ twoper night in the intervention group compared with con-trols. Infant sleep problems are not confined to nightwaking per se; they also include parents’ interpretationsof infant night waking and signaling [23].The severity measure was taken from the Longitu-dinal Study of Australian Children - a large nationallyrepresentative study using primary caregiver report ona scale about children’s sleep (no problem, or mild,moderate, or severe problem) [6, 11, 25, 26]. Australianparents’ reports of sleep problem severity were robust in-dicators of frequent night waking [26]. The AmbulatoryMonitoring Micromini-motion logger® was used in a zerocrossing mode [27], with upgraded Action-W® version 2.7software to collect and analyze actigraphy data [28]. Theactigraphs were worn on infants’ left ankles for 6 days.The software incorporates Sadeh’s algorithm [28] for dif-ferentiating sleep and wakes in infants less than one yearof age. Most studies employing actigraphy reported usingAmbulatory Monitoring actigraphs [29]. Actigraphic datahave had high rates of agreement with polysomnography(PSG) recordings [30, 31]. Following downloading, a phys-ician, blinded to group assignment, scored all of the acti-graph data. Families also completed an infant sleep diaryand a form with settling and rising and actigraph removaland reapplication times to assist with interpretation of theactigraphy data. Sleep diaries have been used in large lon-gitudinal studies to determine children’s sleep durationand night waking [32].Our secondary outcomes were infants’ longest sleeptime in minutes (actigraphy) and mean wakes (actigraphyand diary) and parents’ experiences, using the Multi-dimensional Assessment of Fatigue Scale [MAF] [33],Center for Epidemiologic Studies Depression Measure[CESD] [34], Pittsburgh Sleep Quality Index [PSQI] [35],and Maternal (parental) Cognitions about Infant SleepQuestionnaire [MCISQ] [36], at six weeks post-teachingsession. For psychological measures, higher scores indicatemore difficulty. There is support for validity and reliability;instrument testing occurred in the pilot study [14, 15]. Forthe trial, Cronbach’s alphas were: MAF 0.94, 0.95; CESD0.90, 0.89; PSQI 0.64, 0.53; MCISQ 0.79, 0.84. The MCISQhas not been validated with fathers; however, Morrell’sitems were developed from therapy vignettes for couplesexperiencing an infant sleep problem [36] and otherstudies have used the measure with mothers and fathers[22, 23]. Our original secondary hypothesis specified sig-nificantly improved changes in experimental versus con-trol group parents’ experiences; however, we capitalizedon data from both parents by conducting a post hocanalysis comparing primary and secondary caregiversseparately.Statistical analysesOur sample size was based on detecting an arithmeticdifference of 20 % in outcome proportion reportingsevere sleep problems between the intervention andcontrol groups [6], using results obtained by Hiscockand colleagues’ (2007) who reported 70 % in controlgroup and 50 % in intervention group. That absolute dif-ference required 97 subjects per group to obtain powerTable 2 Training program for sleep intervention nursesContent▪ Circadian rhythms & sleep cycle characteristics▪ Normal sleep amount & patterns for 6-to-12 month-olds▪ Developmental shifts in infant sleep and unrealistic parentalexpectations▪ Effects of sleep fragmentation & short cycles▪ Routines daytime & pre-sleep▪ Negative sleep associations▪ Effects of sleep problems on infants▪ Effects of sleep problems on parents▪ Trials and reviews of behavioral sleep interventions▪ Strategies to reduce night waking▪ Screening infants for conditions requiring medical referralSkills▪ Screening infants for conditions requiring medical referralHall et al. BMC Pediatrics  (2015) 15:181 Page 5 of 12of 0.80 in a two-sided test with type I error rate of 0.05.Allowing for loss of follow up of up to 20 %, our plannedsample size was 240 families; we recruited and random-ized a total of 235 families. We did not incorporate sec-ondary outcomes in our power calculation. No interimanalysis was planned.The primary analyses were conducted on an intention-to-treat basis considering a two-tailed p-value ≤ 0.05 assignificant and using R (version 2.13.0). We comparedobserved proportions of parents reporting severe sleepproblems and actigraphic wakes of ≥2 per night betweengroups using a Fisher’s exact test, with adjustment forbaseline sleep problem severity using the Mantel-Haenszeltest, including corresponding 95 % confidence intervalsfor differences in proportions or relative risks. Means forcontinuous outcomes were compared using linear (bothfixed and mixed effects) model analyses, with adjustmentfor baseline measurements. We adjusted our analysisof sleep problem severity for infant gender and feedingstatus.Because families were assigned to groups associatedwith particular health centers and providers we examinedhealth center and provider effects on primary outcomesusing mixed effects logistic regression. In addition, wegenerated multiple imputations for incomplete data usingiterative regression imputation [37]. The results reportedare based on the available data. Multiple imputation wasundertaken to confirm the validity of the available dataanalysis.ResultsWe screened 386 families for study eligibility (Fig. 1).Sixty-eight infants (17.6 %) were excluded because theywere: outside the age range (n = 28), had chronic healthproblems (n = 2), or did not meet the BSP criteria (n = 38).Thirty-eight parents (9.8 %) were excluded because theylived outside the study catchment (n = 10), were unavail-able for training sessions (n = 5), or had diagnoses ofdepression or sleep apnea (n = 23). Twenty-seven families(7 %) refused participation because they regarded data col-lection as too onerous. Of 253 families (66 %) that agreedto baseline data collection, 18 (7 %) could not be ran-domized due to infant illness (n = 1), family bereavement(n = 1), parents separating (n = 1), and regarding the studyas too onerous (n = 15). Two hundred and thirty-five fam-ilies (462 parents) were randomized to the interventionand control groups. At six weeks, 110 families (206 par-ents) were in the intervention group and 108 families (204parents) were in the control group. Loss to follow-up atthe six-week outcome collection point was 6 % in theintervention group and 7.4 % in the control group.At baseline (Table 3), parents had a mean age of35 years, a mean of 17 years of education, and most hada partner. Most families had one child. Family incomeranged from $10,000 to ≥ $110,000 per annum, withabout 40 % of the sample reporting incomes between$10,000 and $89,999 CAD per annum. The majority ofthe sample self-identified as Canadian, with the next lar-gest groups reported as European, Chinese, and SouthAsian. The groups were similar except there were moremale infants and fewer breastfeeding infants in the inter-vention group compared with the control group. Bothparents attended the sleep session in 86 % of familiesand the safety session in 62 % of families. An average ofnine parents per group attended each sleep and safetyteaching session. For follow-up telephone calls, 98 % ofsleep group and 85 % of safety group families receivedthe first call, 96 % and 80 % received the second call,94 % and 80 % received the third call, and 86 % and79 % received the fourth call. The sleep group averaged3.7 calls per family and the safety group 3.3 calls perfamily.Primary outcomeIncomplete actigraphic data (missing epochs due to sig-nal loss) for a 24-h period were excluded from analysisand occurred similarly across intervention and controlTable 3 Baseline demographic variables for infants and parentsCategory Sleep intervention Safety controlInfants n = 117 n = 118Age, mean (SD), mo 6.7 (0.92) 6.8 (0.96)Male, No. (%) 74 (64) 57 (48)**Breastfed, No. (%) 99 (85) 113 (96)**Parents n = 229 n = 233Age, mean (SD), y 35.5 (5.6) 35.4 (5.1)Married or in stablerelationship, No. (%)110 (97) 110 (97)Number of children, mean (SD) 1.3 (0.7) 1.3 (0.7)Education, mean (SD), y 17 (2.8) 17 (2.8)Family Income,Canadian dollars, No. (%)$10,000 - 29,999 12 (6) 8 (4)$30,000 - 59,999 22 (11) 42 (20)$60,000 - $89,999 36 (17) 42 (20)$90,000 -109,000 56 (27) 32 (15)≥ $110,000 81 (39) 91 (42)aCultural Identity, No. (%)bCanadian 111 (50) 123 (54)Chinese 23 (10) 19 (8)European 30 (14) 25 (11)South Asian 21 (9) 20 (9)Other 38 (17) 42 (18)aRounding error. bParents self-determined cultural identityNote: **p < .01Hall et al. BMC Pediatrics  (2015) 15:181 Page 6 of 12groups (7.6 % and 8.1 % respectively). At six weeks post-intervention, 96 actigraphy records were analyzed for eachgroup. Ninety-four control group infants had an averageof ≥2 wakes per night compared to 93 intervention groupinfants, a risk difference of -0.2 % (95 % CI: −1.32, 0.91).At six weeks, 4 % of infants in the intervention group(n = 4) compared to 14 % of infants in the control group(n = 15) had parental reports of severe sleep problemscores (relative risk of 0.26 [95 % CI: 0.09, 0.77]); adjustingfor baseline scores yielded an estimate of 0.30 (95 % CI:0.11, 0.84) and a risk difference of -10% (95% CI: -16.8,-2.2) (Table 4). No estimates were substantially affected byadjustment for baseline characteristics. Adjusting for in-fant gender and feeding status did not alter the sleep prob-lem severity results. There was no indication of pertinentvariation between centers or providers.Secondary outcomesAt six weeks, there was no difference between the inter-vention and control groups for mean change in acti-graphic wakes or long wake episodes adjusted for baseline;however, there was a significant increase in the inter-vention compared to control infants’ longest sleep time(Table 4). Diary data were provided for 106 interventionand 106 control infants. Parents recorded significantlyfewer wakes for intervention infants than control infants;31.1 % of intervention infants compared to 60.4 % controlinfants had ≥2 night wakes (Table 4).After adjusting for baseline, change in parents’ psycho-logical measures indicated significant improvements forthe intervention compared to the control group (Table 5).Intervention group parents’ fatigue, sleep quality, and de-pressed mood improved significantly compared to controlgroup parents. As indicated, we conducted a post hocanalysis to compare changes in primary and secondarycaregivers’ psychological variables between groups, afteradjusting for baseline. For the intervention group, bothprimary and secondary caregivers’ sleep quality and fatigueimproved significantly compared to the control group(Table 6). Depression improved for the primary caregiversin the intervention group compared to the control groupbut not for secondary caregivers.When we examined parental cognitions about sleep,after controlling for baseline, there was a significant im-provement in all areas of cognition, except for sleepsafety, on comparing intervention parents with controls(Table 5). In the post hoc analysis we analyzed data forprimary and secondary caregivers separately. For bothprimary and secondary caregivers the interventiongroups’ doubts about managing infant sleep, comfortmanaging sleep and feeding, and comfort setting limitsaround infant sleep improved significantly compared tothe control group (Table 6). Primary caregivers’ cognitionsof anger about infant sleep but not secondary caregivers’cognitions improved significantly for the interventiongroup compared to the control group. There were nosignificant differences in intervention group primary orsecondary care providers’ concerns about sleep safetycompared to the control group.DiscussionGiven the frequency of BSPs in infancy and their nega-tive long-term effects on parents and children [1–9]brief and effective interventions to manage BSPs are im-portant. Ninety percent of American school-aged chil-dren have received less than the recommended hours ofsleep [38]. Finding ways to reach parents and assist themto recognize BSP as amenable to change early in chil-dren’s development can potentially improve parents’knowledge about sleep, factors influencing sleep, andapproaches to managing children’s sleep. This is the firsttrial of the efficacy of a cognitive-behavioral groupintervention (CBGI) for parents with infants from 6- to8-months of age with BSPs. While the control groupTable 4 Infant sleep characteristics at baseline and 6 weeksSleep intervention Safety control Adjusted differenceat outcome95 % confidenceintervalP-valueBaseline 6 Week Baseline 6 WeekActigraphy n = 113 n = 96 n = 109 n = 96Night wake episodes 8.2 (3.8) 7.9 (5.4) 8.8 (3.4) 7.7 (4.3) −0.2 −1.32 to 0.91 0.72Long wake episodes 4 (1.5) 3.2 (1.6) 4.2 (1.4) 3.2 (1.2) 0.02 −0.35 to 0.4 0.91Longest sleep period 164 (46.2) 204.4 (87.5) 168 (53.2) 188.1 (50.2) 20.02 0.48 to 39.56 0.05Sleep diary n = 114 n = 106 n = 116 n = 106Night wake episodes 3.1 (1.2) 1.7 (1) 3.1 (1.2) 2.2 (1.1) −0.45 −0.7 to −0.19 <.001% infants with sleep problem(average = 2 wakes per night)93 (81.6 %) 33 (31.1 %) 96 (82.8 %) 64 (60.4 %) −29.9 % −43.63 to −16.22 <.001Parent report n = 117 n = 108 n = 118 n = 107% of infants with severe night waking 32 (14 %) 4 (4 %) 44 (18 %) 15 (14 %) −10 % −16.8 to −2.2 0.01Descriptive statistics are reported as Mean (SD) or n (%)Hall et al. BMC Pediatrics  (2015) 15:181 Page 7 of 12also improved over time, our principal findings (adjustedfor baseline) indicated a significant improvement inparents’ perceptions of the severity of the infant sleepproblem, reduction in numbers of night wakes bysleep diary, increase in length of longest night sleepby actigraphy, and improvement in parents’ cognitionsabout infant sleep, fatigue, sleep quality, and depres-sion in the intervention group compared to the controlgroup.The results, including no significant reduction in nightwaking by actigraphy, support the efficacy of our inter-vention and our goal to assist parents to accept normalinfant arousal behavior by understanding the effects ofself-soothing. The diary data demonstrated that a clinic-ally significant proportion of infants in the interventiongroup managed to return to sleep following typical nightarousals without signaling their parents. Behavioral in-terventions are intended to assist infants to self-soothe back to sleep rather than to prevent nightwaking. In the intervention content we emphasizedlinks between parental responses to infants’ cryingand signaling and infants’ failure to learn to self-sootheto return to sleep following typical night waking.Parental responses to infant signaling can interferewith self-soothing and extend the duration of infants’night waking [39].Table 5 Comparison of intervention and control group parents for psychological variablesBaseline mean (SD) (n) 6 week follow-upmean (SD) (n)Baseline adjusteddifference95 % confidenceintervalP-valueFatigue MAFaSleep intervention 26.8 (9.2) (n = 206) 18.7 (8.1) (n = 206) −3.7 −5.74 to −1.68 0.001Safety control 27.1 (8.6) (n = 204) 22.3 (9.2) (n = 204)Depression CES-DbSleep intervention 13.8 (9) (n = 206) 9.4 (7.7) (n = 206) −2 −3.7 to −0.4 0.02Safety control 15.4 (10.2) (n = 205) 12 (9) (n = 205)Sleep quality PSQIcSleep intervention 8.1 (3.6) (n = 206) 5.7 (3) (n = 206) −0.88 −1.5 to −0.2 0.009Safety control 8.3 (3.4) (n = 201) 6.5 (3.3) (n = 202)Cognitions MCISQdSleep intervention n = 223 n = 205Safety control n = 230 n = 205Sleep doubtseSleep intervention 7.2 (4.1) 4.3 (3.6) −1.3 −2.0 to −0.6 <.001Safety control 6.9 (4.2) 5.5 (4)Sleep angerfSleep intervention 6.8 (3.4) 5.2 (3.1) −1.1 −1.8 to −0.4 0.003Safety control 7.3 (4) 6.5 (3.8)Sleep and feedinggSleep intervention 7.3 (3.6) 3.9 (3.4) −1.4 −2.1 to −0.7 <.001Safety control 6.9 (3.6) 5.2 (3.3)Setting sleep limitshSleep intervention 14.9 (4.9) 10.1 (4.8) −2.48 −3.5 to −1.5 <.001Safety control 14.9 (4.9) 12.4 (5.2)Sleep safetyiSleep intervention 2.9 (2.5) 1.9 (2) −0.3 0.7 to 0.1 0.12Safety control 2.7 (2.4) 2.2 (2.3)aMultidimensional Assessment of Fatigue Scale (global score range 1–50; higher scores indicate greater fatigue)bCentre for Epidemiologic Studies Depression Measure (score range 0–60, higher scores indicate worse depression)cPittsburgh Sleep Quality Index (global score range 0–21; higher scores indicate worse sleep quality)dMaternal Cognitions about Infant Sleep Questionnaire (higher scores indicate more parent difficulty)Subscale score range for: eDoubts about managing sleep = 0–25, fAnger about infant sleep = 0–25gManaging infant sleep and feeding = 0–15, hSetting i nfant sleep limits = 0–25, iInfant sleep safety = 0–10. The means were adjusted for baselineHall et al. BMC Pediatrics  (2015) 15:181 Page 8 of 12Adjusting for baseline, there was not a significantimprovement in actigraphy night waking in the inter-vention group compared with the controls, even whenwe compared the groups on long wakes. Our resultsfit with emerging research suggesting that actigraphslack specificity to detect wakes in infants [29]. Acti-graphy data have shown low specificity for children’swakes but high intraclass correlations with polysom-nography for sleep duration [40].The differences between primary and secondary care-givers’ improvement in depression and sleep anger fit withfindings of other studies. For example, Hiscock and Wakereported that mothers who regarded their infants’ sleep asa problem were more likely to have depression and depres-sion scores increased with sleep problem severity [41].Another study reported significant correlations betweenmaternal sleep cognitions and depression scores, withmothers of children with sleep problems scoring signifi-cantly higher on anger about sleep than mothers of controlchildren [42]. In our study, primary caregivers were theparents engaging with settling infants to sleep, nightwaking, and the intervention.Strengths and limitationsThe trial responded to a number of criticisms of sleepinterventions [13] by offering a small group format, arelatively brief intervention, a combination of objectiveand subjective sleep measures, and a standardized defin-ition of a behavioral sleep problem [19]. The trial waspreceded by a pilot study [14, 15] and incorporated a stan-dardized intervention through formal training of nurses,scripted interventions, systematic review of interventionTable 6 Comparison of intervention and control group by caregiver on psychological variables at 6 weeksVariable & caregivers Sleep intervention Safety control Baseline adjusted difference 95 % confidence interval P valueMean (SD) n Mean (SD) nFatigue MAFaPrimary caregiver 19.3 (8.1) 108 23.5 (9.2) 105 −4.2 −6.45 to −1.96 <.001Secondary caregiver 18.1 (8.1) 98 21.1 (9) 99 −2.7 −4.90 to −0.50 .02Depression CES-DbPrimary caregiver 9.1 (7.9) 108 12.5 (8.4) 106 −2.87 −4.81 to −0.93 .004Secondary caregiver 9.7 (7.5) 98 11.5 (9.7) 100 −0.77 −2.89. to 1.36 .48Sleep quality PSQIcPrimary caregiver 6.2 (3.1) 108 7.1 (3.4) 107 −0.88 −1.70 to −0.06 .04Secondary caregiver 5.1 (2.8) 98 5.9 (3.1) 95 −0.72 −1.45 to 0.01 .05Cognitions MCISQdSleep doubtsePrimary caregiver 4.6 (3.5) 108 5.9 (4) 107 −1.56 −2.43 to −0.68 <.001Secondary caregiver 3.9 (3.7) 97 5.1 (4.1) 98 −1.26 −2.14 to −0.39 .005Sleep angerfPrimary caregiver 5 (3.3) 108 6.6 (4.2) 107 −1.37 2.25 to - 0.50 .002Secondary caregiver 5.3 (2.9) 97 6.3 (3.3) 98 −0.75 1.54 to 0.31 .06Sleep and feedinggPrimary caregiver 4.5 (3.6) 108 6 (3.3) 107 −1.59 2.41 to - 0.77 <.001Secondary caregiver 3.2 (3.2) 97 4.4 (3.2) 98 −1.4 2.19 to - 0.61 <.001Setting sleep limitshPrimary caregiver 10.8 (4.8) 108 13.5 (5.2) 107 −2.63 −3.80 to −1.47 <.001Secondary caregiver 9.2 (4.8) 97 11.1 (4.9) 98 −2 −3.12 to −0.88 <.001Sleep safetyiPrimary caregiver 2.2 (2) 108 2.5 (2.2) 107 −0.42 0.91 to 0.07 .09Secondary caregiver 1.7 (2) 97 2 (2.3) 98 −0.3 0.80 to 0.20 .25aMultidimensional Assessment of Fatigue Scale (global score range 1–50; higher scores indicate greater fatigue)bCentre for Epidemiologic Studies Depression Measure (score range 0–60, higher scores indicate worse depression)cPittsburgh Sleep Quality Index (global score range 0–21; higher scores indicate worse sleep quality)dMaternal Cognitions about Infant Sleep Questionnaire (higher scores indicate more parent difficulty)Subscale score range for: eDoubts about managing sleep = 0–25, fAnger about infant sleep = 0–25gManaging infant sleep and feeding = 0–15, hSetting infant sleep limits = 0–25, iInfant sleep safety = 0–10. The means were adjusted for baselineHall et al. BMC Pediatrics  (2015) 15:181 Page 9 of 12fidelity, and less than 10 % attrition at primary outcome. Inthe pilot study [14, 15], the principal investigator deliveredall of the sleep interventions for the seven groups of parentsand provided all of the telephone support thereby ensuringfidelity was maintained. We created similar exposure toattention for the sleep and safety groups and blinded ourparticipants to our hypotheses [43]. We incorporatedsecondary care providers (fathers) in our trial in contrast toprevious foci on mothers alone [21], given evidence bothparents influence children’s sleep patterns [22].Exclusion of parents who did not read or speakEnglish and research participant characteristics (older,well-educated and high income) limits the generaliza-bility of results. It is interesting that our sample is rela-tively representative of the population being served.About 40 % of our sample reported average familyincomes of between $10,000 and $89,999 CAD; thesefamily income levels are relatively common in the citywhere the study was conducted. In 2011, the mean andmedian household incomes for Metro Vancouver were$83,666 CAD and $63,347 respectively [44] and mediancouple income in Vancouver in 2012 was reported as$76,690 CAD [45]. In Vancouver in 2011, 60 % of adultsreported university education or college diplomas [46].Lack of blinding for parent participants had the poten-tial to bias the study results. We asked about other re-sources parents accessed but did not place limits onparents’ access to other forms of help, such as sleep con-sultants. We did not control for parents’ access to otherservices because we intended the trial to resemble publichealth nurses’ practice where parents would have unlim-ited access to other resources. The lengthy recruitmentperiod increased the possibility that control group parentswere contaminated by conversing with parents, who re-ceived the trial intervention. Both lack of parental blindingand contamination of the control group could potentiallyhave contributed to underestimating the effect size of theoutcome. Some parents might prefer one-to-one ratherthan group formats to assist with problems.We did not compare intervention and control groupsfor sleep-onset difficulties in our study for several rea-sons. At baseline, parents were often rocking or feedingtheir infants to sleep. Thus, the actigraphic mean forsleep onset latency at baseline was 0.58 min. Parentsoften reported settling their infants after they specifiedsleep onset on written diaries. In other words, infants wereasleep when parents placed them in their cribs. Infants areunable to indicate when they try to initiate sleep so wesuggest that the standard definition of sleep latency doesnot apply to this developmental group.We were not surprised that, despite significant differ-ences between groups on infant gender and breastfeedingstatus at baseline (Table 3), adjusting for their status didnot affect our results for sleep problem severity. In largemultinational studies, neither gender nor breastfeedingstatus has influenced night waking [47, 48]. It has beenbreastfeeding to sleep that has been associated with sleepproblems [48] and our intervention recommended thatparents refrain from feeding infants to sleep.The availability of public health nurses trained in behav-ioral sleep interventions creates potential for nurses to offerinterventions through contact with families attending grouppostnatal drop-ins. Not only can situating a short-termgroup intervention in public health units overcome barriersto families receiving help for common infant BSPs [49, 50]but also being exposed to other families experiencing aninfant BSP decreases families’ sense of isolation and helpsthem regard their infants’ problems as common and amen-able to change [16]. Contacting families by telephone forfollow-up could be factored into public health nurses’ dailyworkload. Sleep consultants in the area routinely chargefamilies about $250 to $450 per consultation, thus poten-tially limiting families’ access to such services. Parents’changes in cognitions, observed in our study, suggest thattheir thinking changed when provided with evidence-basedinformation about infant sleep and strategies to reducesleep problems by skilled practitioners. Future studies couldincorporate video surveillance of infant sleep, a morevalid way of identifying insomnias [51], indicators ofself-soothing, and attachment measures to provideevidence about effects of interventions on infants.ConclusionsCompared to parents in a control group, parents exposedto a CBGI experienced significantly improved perceptionsof infant sleep, sleep cognitions, mood, sleep quality,and fatigue, but not number of wakes measured usingactigraphy.AbbreviationsBSP: Behavioral sleep problem; CBGI: Cognitive-behavioral groupintervention; CESD: Center for Epidemiologic Studies Depression Measure;MAF: Multidimensional Assessment of Fatigue Scale; MCISQ: Maternal(parental) Cognitions about Infant Sleep Questionnaire; PSQI: PittsburghSleep Quality Index.Competing interestsThe authors declare that they have no competing interests.Authors’ contributionsWH conceptualized and designed the trial, obtained funding, directedimplementation, participated in data analysis and interpretation, wrote thedraft manuscript, and is guarantor. EH, JPC, and AG assisted in all trialactivities, including design, funding, implementation, data interpretation,and manuscript preparation. RS conducted all of the actigraphy analysisand assisted with manuscript preparation. RFB assisted in design, funding,data analysis and interpretation, and manuscript preparation. RB, KT, LT, andJW participated in trial design, including the intervention and manuscriptpreparation. KG assisted in all trial implementation procedures includingparticipant recruitment, overseeing implementation and data collectionprocedures, budget management, managing the database, and manuscriptpreparation. OI assisted in trial funding and was available for clinicalconsultation during implementation. All authors read and approved thefinal manuscript.Hall et al. BMC Pediatrics  (2015) 15:181 Page 10 of 12Author’s informationOver 9 years, WH has provided voluntary sleep consultations to over 1000families with children with behavioral sleep problems, as well as sessions forfoster parents in a community health program. The demand, without anyform of advertising, is an indicator of the number of families unable toaccess assistance with children’s sleep problems. Joanne Wooldridge is theRegional Leader for Early Child Development.AcknowledgementsWe acknowledge the families who participated in the study and shared theirexperiences with us. This work was funded by a Canadian Institutes ofHealth Research grant (no MCT – 94836) awarded to Dr. Hall. The researchersconducted the trial and analyzed the data with complete independencefrom the Canadian Institutes of Health Research.FundingCanadian Institutes of Health Research grant (no MCT – 94836).Author details1University of British Columbia School of Nursing, T 201, 2211 Wesbrook Mall,Vancouver, BC V6T 2B5, Canada. 2Midwifery Education Program, McMasterUniversity, Michael G DeGroote Centre for Learning & Discovery, Room 2210,1200 Main Street West, Hamilton, ON L8N 3Z5, Canada. 3Department ofStatistics, University of British Columbia/Child and Family Research Institute,ESB 3146, 2207 Main Mall, Vancouver, BC V6T 1Z4, Canada. 4Child and FamilyResearch Institute, University of British Columbia, Clinical Support Building,Room V3-320, 948 West 28th Avenue, Vancouver, BC V6H 3N1, Canada.5University of British Columbia School of Nursing, Vancouver, BC, Canada.6University of British Columbia Faculty of Medicine, 2329 West Mall,Vancouver, BC V6T 1Z4, Canada. 7British Columbia Children’s Hospital,Division of Developmental Pediatrics, 3644 Slocan Street, Vancouver, BC V5M3E8, Canada. 8Department of Clinical Epidemiology and Biostatistics, Facultyof Health Sciences, McMaster University, 1280 Main Street West, CRL-208,Hamilton, ON L8S 4K1, Canada. 9Pacific Spirit Community Health Centre,Vancouver Coastal Health, 2110 43rd Avenue West, Vancouver, BC V6M 2E1,Canada. 10South Community Health Centre, Vancouver Coastal Health, 6405Knight Street, Vancouver, BC V5P 2V9, Canada. 11South Community HealthCentre, Vancouver Community, Vancouver Coastal Health, 6405 Knight Street,Vancouver, BC V5P 2V9, Canada. 12Early Childhood Development atVancouver Coastal Health, Vancouver Coastal Health, 11th floor, 601 WestBroadway, Vancouver, BC V5Z 4C2, Canada.Received: 10 June 2015 Accepted: 22 October 2015References1. 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Sleep. 2008;31:395–401.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitHall et al. BMC Pediatrics  (2015) 15:181 Page 12 of 12

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