NCT04048785

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

July 31, 2019

Last Update Submit

December 17, 2020

Conditions

Infant Sleep Problem

Keywords

Child health careBehavior sleep interventionMental healthSocial emotional development

Outcome Measures

Primary Outcomes (2)

  • Infant sleep measured by Actigraphy

    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

    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 Outcomes (1)

  • Infant social-emotional development

    changes from baseline, 4 weeks and 8 weeks after the intervention

Study Arms (2)

control

NO INTERVENTION

Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys

Infant behavioral sleep intervention

EXPERIMENTAL

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

Interventions

Behavioral sleep interventionOTHER

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.

Infant behavioral sleep intervention

Eligibility Criteria

Age5 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (22)

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    PMID: 20137989BACKGROUND

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    PMID: 17956744BACKGROUND

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    PMID: 20363166BACKGROUND

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    PMID: 23181013BACKGROUND

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    PMID: 20337191BACKGROUND

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    PMID: 14640818BACKGROUND

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    PMID: 20368477BACKGROUND

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    PMID: 26899742BACKGROUND

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    PMID: 26836644BACKGROUND

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    PMID: 20119503BACKGROUND

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    PMID: 17158146BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Jiang Fan, PhD

    Shanghai Jiao Tong University School of Medicine

    STUDY CHAIR

Central Study Contacts

Jiang Fan, PhD

CONTACT

021-38626161fanjiang@shsmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Trial participants and individuals assessing the outcomes are blinded to the participant's condition
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
staff of Research Department

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 7, 2019

Study Start

April 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

not yet decided

Locations

CN(1)