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Clinical Trials/NCT04539990
NCT04539990
Unknown
Not Applicable

A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

Soroka University Medical Center0 sites100 target enrollmentOctober 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Soroka University Medical Center
Enrollment
100
Primary Endpoint
Child Sleep Habits Questionnaire
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2020
End Date
September 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Child Sleep Habits Questionnaire

Time Frame: 8 weeks after program begins

Parent questionnaire regarding sleep habits of their child

Night time sleep as measured by Fitbit sensor

Time Frame: 8 weeks after program begins

Sensor is placed on the arm of the child for 5 days and measures sleep

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