A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

August 31, 2020 updated by: Soroka University Medical Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Sleep Treatment

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.
Behavioral: Behavioral treatment for sleep difficulties
This intervention is mediated by the parents. Parents are educated regarding sleep hygiene and instructed to follow simple rules which create a reliable evening routine and reduce exposure to stimulating factors that delay sleep onset (e.g., caffeine or exercise). In addition, parents are asked to initiate a "fading" behavioral protocol whereby they teach their child to fall asleep independently, with less parental attention. This requires parents to limit their interaction with their child after the children are put to bed so as not to interfere with sleep onset. This includes limiting conversations and lying in bed with the child. This behavioral approach is applied gradually and is expected to reduce the time it takes children to fall asleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Sleep Habits Questionnaire
Time Frame: 8 weeks after program begins
Parent questionnaire regarding sleep habits of their child
8 weeks after program begins
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
8 weeks after program begins

Collaborators and Investigators

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

Sponsor

Soroka University Medical Center

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 (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor 0266-20 ctil

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.

Clinical Trials on Sleep

Clinical Trials on Behavioral treatment for sleep difficulties

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe