The Effects of Behavioral Sleep Intervention on Infant Sleep and Social-emotional Development
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Sleep Problem
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Infant sleep measured by Actigraphy
- Last Updated
- 5 years ago
Overview
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.
Investigators
Sijia Gu
staff of Research Department
Shanghai Jiao Tong University School of Medicine
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.
Outcomes
Primary Outcomes
Infant sleep measured by Actigraphy
Time Frame: changes from baseline, 4 weeks and 8 weeks after the intervention
Sleep-wake patterns are determined using actigraphy, which has been established as a valid method to objectively assess sleep in the infant's natural setting. Parents were asked to attach a actigraph (Motionlogger, Ambulatory Monitoring, Inc., Ardsley, NY, USA) to their child's ankle for 7 days at each assessment period. Data was scored using the Sadeh algorithm, which is the most commonly used analysis method in pediatric populations. Sleep diaries were completed by parents and used to identify and amend any irregularities in actigraphic data. The following actigraphic sleep metrics were used: 1) wake after sleep onset (WASO); 1) sleep of latency (SOL); and 3) number of awakenings (NW).
Infant sleep measured by Brief Infant Sleep Questionnaire
Time Frame: changes from baseline, 4 weeks and 8 weeks after the intervention
The BISQ is a well-validated sleep questionnaire aimed at assessing parent-reported infant sleep patterns. Parents completed the BISQ at each assessment point. The derived measures used in this study were: (1) sleep onset latency (SOL); (2) wake after sleep onset (WASO); and (3) number of awakenings.
Secondary Outcomes
- Infant social-emotional development(changes from baseline, 4 weeks and 8 weeks after the intervention)