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Behavioral Sleep Intervention and Infant Sleep and Social-emotional Development

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT04048785
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
21
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Behavioral sleep intervention
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Trial participants and individuals assessing the outcomes are blinded to the participant's condition
Primary Purpose:
Treatment
Official Title:
The Effects of Behavioral Sleep Intervention on Infant Sleep and Social-emotional Development
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: control

Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys
Experimental: Infant behavioral sleep intervention

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, 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.

Other: Behavioral sleep intervention
The intervention consists of an infant behavioral sleep protocol. In the tailored intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings.

Outcome Measures

Primary Outcome Measures

  1. Infant sleep measured by Actigraphy [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).

  2. Infant sleep measured by Brief Infant Sleep Questionnaire [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 Outcome Measures

  1. Infant social-emotional development [changes from baseline, 4 weeks and 8 weeks after the intervention]

    ASQ:SE2 consists of a set of multiple choice questions that should be completed by caregivers of the infant. The questions are divided into forms according to age, and ask about behaviour in different areas: 1) self-regulation; 2) conformity; 3) adaptive functioning; 4) autonomy; 5) affect; 6) social communication; and 7) interaction with other persons. It makes it possible to detect if there is a risk in infant social-emotional development. Developed as an ecologically-valid procedure for assessing emotion regulation (the foundation of the social-emotional development) in the context of parent-child interaction, the Still face procedure enables examination of infant modulation of affect, attention, and behavior in socially-stressful situations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Months to 18 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine Shanghai Shanghai China

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Jiang Fan, PhD, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sijia Gu, staff of Research Department, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT04048785
Other Study ID Numbers:
  • SCMCIRB-K2018013
First Posted:
Aug 7, 2019
Last Update Posted:
Dec 21, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sijia Gu, staff of Research Department, Shanghai Jiao Tong University School of Medicine
Child health care
Behavior sleep intervention
Mental health
Social emotional development
Additional relevant MeSH terms:
Dyssomnias
Parasomnias

Study Results

No Results Posted as of Dec 21, 2020