Behavioral Sleep Intervention and Infant Sleep and Social-emotional Development

December 17, 2020 updated by: Sijia Gu, Shanghai Jiao Tong University School of Medicine

The Effects of Behavioral Sleep Intervention on Infant Sleep and Social-emotional Development

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
changes from baseline, 4 weeks and 8 weeks after the intervention
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.
changes from baseline, 4 weeks and 8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant social-emotional development
Time Frame: 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.
changes from baseline, 4 weeks and 8 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 5, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMCIRB-K2018013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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