A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

Not Applicable

• Conditions: Autism Spectrum Disorder; Sleep; Autism
• Interventions: Behavioral: Behavioral treatment for sleep difficulties

• Registration Number: NCT04539990
• Lead Sponsor: Soroka University Medical Center

Brief Summary

The present study will test the effectiveness of a behavioral intervention program that targets sleep problems in 1.5-5-year-old children with ASD. Sleep patterns will be measured using questionnaires and sleep diaries that will be completed by the parents as well as by Fitbit sensors that will be placed on the child's wrist or back of the arm. The study will also explore whether specific child (e.g., severity of cognitive abilities) or parent characteristics (e.g., parent stress levels) impact the effectiveness of the intervention. In addition, we will examine whether changes in sleep disturbances are associated with changes in the family's quality of life.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07
• Study Start: 2020-10
• Primary Completion: 2022-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Parents of 1.5-5-year-old children with autism will be asked to fill the Child Sleep Habits Questionnaire (CSHQ). Those who report high scores on the following 3 CSHQ subscales will be invited to participate: bedtime resistance, sleep onset delay, and night-wakings.

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Sleep Treatment	Behavioral treatment for sleep difficulties	Parents of children with autism will come to two group meetings (up to 5 families in each group) where they will be receive information regarding sleep hygiene and behavioral techniques for reducing sleep onset delays and night awakenings. The program will last 8 weeks. Meetings will be held on week 1 and week 3. In addition parents will receive a weekly phone call where they will be asked about their ability to implement the behavioral techniques. Sleep of the children will be measured using questionnaires, sleep diaries and with a Fitbit sensor before and after the program.

Primary Outcome Measures

Name	Time	Method
Child Sleep Habits Questionnaire	8 weeks after program begins	Parent questionnaire regarding sleep habits of their child
Night time sleep as measured by Fitbit sensor	8 weeks after program begins	Sensor is placed on the arm of the child for 5 days and measures sleep