Clinical trial NCT04048785: Behavioral Sleep Intervention and Infant Sleep and Social-emotional Development
Official title: The Effects of Behavioral Sleep Intervention on Infant Sleep and Social-emotional Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Sleep Problem
Keywords: Child health care
Behavior sleep intervention
Mental health
Social emotional development
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
Primary purpose: TREATMENT

Brief summary: An estimated 30-50% of infants have frequent problematic night wakings. Sleep disturbances have been linked to various adverse outcomes in children, including social-emotional development delay. Despite some evidence of the effectiveness of Infant behavioral sleep intervention, the benefits on children's social-emotional development are worthy of further exploration. The aim of this study is to evaluate the efficacy of behavioral sleep interventions on improving infant sleep and social-emotional development. Infants with behavioral sleep disturbances are randomized into one of the two conditions: Behavioral sleep intervention or no treatment. And infant sleep and social-emotional development were assessed for both group at baseline, and four and eight weeks after sleep intervention.

Detailed description: Study Design: The study design was a parallel group RCT with two groups (Behavioral sleep intervention and Control) and three assessment points. Sleep was assessed by actigraphy (and sleep daily) and parent-reported Brief Infant Sleep Questionnaire (BISQ) during the week before behavioral sleep intervention, four weeks and eight weeks after sleep intervention. Other measures were collected during a laboratory visit scheduled at the end of each of the three assessment.

Participants: Participants were recruited through web-based media advertisements. Approximately 100 participants will be randomized to behavioral sleep intervention condition or a control condition. Inclusion criteria were: 1) infant age range 5-18 months; 2) significant sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports; and 3) two-parent families with both mother and father willing to participate in study procedures. Exclusion criteria were: 1) infant pervasive developmental disorder or significant medical illness; and 2) any concurrent treatment for infant sleep problems.

Study Procedure: Participants are screened via telephone. Caregivers of the intervention group were instructed to establish tailored behavioral sleep intervention strategies. Control families received no sleep intervention. For infants with sleep problems in control group, any sleep treatment in health care services should be recorded. Infant social-emotional development were assessed by Ages \& Stages Questionnaires: Social-Emotional2 (ASQ:SE2) and behaviors in Still face experiment. During the experiment, the mother and infant engage in a three-step interaction: 1) playing"peek-a-boo" for 60 seconds; 2) mother maintaining a neutral facial expression while looking at the child, not smiling, talking, or touching for 120 seconds still-face (SF) episode; 3) maternal re-engagement with the infant to"peek-a-boo" for a 60 seconds reunion (RE) episode. The study was approved by the Institutional Review Board of Shanghai Children's Medical Center and all parents provided written informed consent.

Intervention: One clinical psychologist and one pediatrician delivered the intervention. The intervention was performed at Shanghai Children's Medical Center after parents signed the informed consent form. Interventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, caregivers should minimize their involvement after putting the infant to bed, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings. Furthermore, families of intervention group received a e-booklet describing their intervention and cell phone support weekly.

Measures: Infant sleep is assessed by Actigraphy and parent-report (sleep diary and Brief Infant Sleep Questionnaire, BISQ); Infant social-emotional development is evaluated by Ages \& Stages Questionnaires: Social-Emotional2 (ASQ:SE2), and behaviors (facial expression, gaze, and self-comforting) in three separate dimensions during the Still face experiment.

Eligibility criteria: Inclusion Criteria:

* Infant age range 5-18 months;
* Sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports;
* Both mother and father willing to participate in study procedures.

Exclusion Criteria:

* Infant pervasive developmental disorder or significant medical illness;
* Any concurrent treatment for infant sleep problems.

Primary outcomes:
measure: Infant sleep measured by Actigraphy
timeFrame: changes from baseline, 4 weeks and 8 weeks after the intervention
measure: Infant sleep measured by Brief Infant Sleep Questionnaire
timeFrame: changes from baseline, 4 weeks and 8 weeks after the intervention
Secondary outcomes:
measure: Infant social-emotional development
timeFrame: changes from baseline, 4 weeks and 8 weeks after the intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jiang Fan, PhD
role: STUDY_CHAIR
References:
citation: Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
citation: Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
citation: Paap MC, Haraldsen IR, Breivik K, Butcher PR, Hellem FM, Stormark KM. The Link between Peer Relations, Prosocial Behavior, and ODD/ADHD Symptoms in 7-9-Year-Old Children. Psychiatry J. 2013;2013:319874. doi: 10.1155/2013/319874. Epub 2012 Dec 18.
citation: Slomski A. Chronic mental health issues in children now loom larger than physical problems. JAMA. 2012 Jul 18;308(3):223-5. doi: 10.1001/jama.2012.6951. No abstract available.
citation: Kahn M, Sheppes G, Sadeh A. Sleep and emotions: bidirectional links and underlying mechanisms. Int J Psychophysiol. 2013 Aug;89(2):218-28. doi: 10.1016/j.ijpsycho.2013.05.010. Epub 2013 May 24.
citation: Baglioni C, Spiegelhalder K, Lombardo C, Riemann D. Sleep and emotions: a focus on insomnia. Sleep Med Rev. 2010 Aug;14(4):227-38. doi: 10.1016/j.smrv.2009.10.007. Epub 2010 Feb 6.
citation: Yoo SS, Gujar N, Hu P, Jolesz FA, Walker MP. The human emotional brain without sleep--a prefrontal amygdala disconnect. Curr Biol. 2007 Oct 23;17(20):R877-8. doi: 10.1016/j.cub.2007.08.007. No abstract available.
citation: Vandekerckhove M, Cluydts R. The emotional brain and sleep: an intimate relationship. Sleep Med Rev. 2010 Aug;14(4):219-26. doi: 10.1016/j.smrv.2010.01.002. Epub 2010 Apr 2.
citation: Payne JD, Chambers AM, Kensinger EA. Sleep promotes lasting changes in selective memory for emotional scenes. Front Integr Neurosci. 2012 Nov 21;6:108. doi: 10.3389/fnint.2012.00108. eCollection 2012.
citation: van der Helm E, Gujar N, Walker MP. Sleep deprivation impairs the accurate recognition of human emotions. Sleep. 2010 Mar;33(3):335-42. doi: 10.1093/sleep/33.3.335.
citation: Zohar D, Tzischinski O, Epstein R. Effects of energy availability on immediate and delayed emotional reactions to work events. J Appl Psychol. 2003 Dec;88(6):1082-93. doi: 10.1037/0021-9010.88.6.1082.
citation: Fernandez-Mendoza J, Vela-Bueno A, Vgontzas AN, Ramos-Platon MJ, Olavarrieta-Bernardino S, Bixler EO, De la Cruz-Troca JJ. Cognitive-emotional hyperarousal as a premorbid characteristic of individuals vulnerable to insomnia. Psychosom Med. 2010 May;72(4):397-403. doi: 10.1097/PSY.0b013e3181d75319. Epub 2010 Apr 5.
citation: Palmer CA, Alfano CA. Sleep and emotion regulation: An organizing, integrative review. Sleep Med Rev. 2017 Feb;31:6-16. doi: 10.1016/j.smrv.2015.12.006. Epub 2016 Jan 14.
citation: Crichton GE, Symon B. Behavioral Management of Sleep Problems in Infants Under 6 Months--What Works? J Dev Behav Pediatr. 2016 Feb-Mar;37(2):164-71. doi: 10.1097/DBP.0000000000000257.
citation: Heckman JJ. Schools, Skills, and Synapses. Econ Inq. 2008 Jun;46(3):289. doi: 10.1111/j.1465-7295.2008.00163.x.
citation: Weisman O, Magori-Cohen R, Louzoun Y, Eidelman AI, Feldman R. Sleep-wake transitions in premature neonates predict early development. Pediatrics. 2011 Oct;128(4):706-14. doi: 10.1542/peds.2011-0047. Epub 2011 Sep 12.
citation: Sun W, Wang G, Jiang Y, Song Y, Dong S, Lin Q, Deng Y, Zhu Q, Jiang F. Six-month-old infant long sleepers prefer a human face. Sleep Med. 2016 Nov-Dec;27-28:28-31. doi: 10.1016/j.sleep.2016.08.018. Epub 2016 Oct 31.
citation: Hunnius S, de Wit TC, Vrins S, von Hofsten C. Facing threat: infants' and adults' visual scanning of faces with neutral, happy, sad, angry, and fearful emotional expressions. Cogn Emot. 2011 Feb;25(2):193-205. doi: 10.1080/15298861003771189.
citation: Korkmaz B. Theory of mind and neurodevelopmental disorders of childhood. Pediatr Res. 2011 May;69(5 Pt 2):101R-8R. doi: 10.1203/PDR.0b013e318212c177.
citation: Alexander GM, Wilcox T, Woods R. Sex differences in infants' visual interest in toys. Arch Sex Behav. 2009 Jun;38(3):427-33. doi: 10.1007/s10508-008-9430-1. Epub 2008 Nov 19.
citation: Wilcox T, Biondi M. fNIRS in the developmental sciences. Wiley Interdiscip Rev Cogn Sci. 2015 May-Jun;6(3):263-83. doi: 10.1002/wcs.1343. Epub 2015 Feb 23.
citation: Hiscock H, Bayer J, Gold L, Hampton A, Ukoumunne OC, Wake M. Improving infant sleep and maternal mental health: a cluster randomised trial. Arch Dis Child. 2007 Nov;92(11):952-8. doi: 10.1136/adc.2006.099812. Epub 2006 Dec 7.