A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

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ClinicalTrials.gov Identifier: NCT04539990

Recruitment Status : Not yet recruiting

First Posted : September 7, 2020

Last Update Posted : September 7, 2020

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Sponsor:

Information provided by (Responsible Party):

Soroka University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism Autism Spectrum Disorder Sleep	Behavioral: Behavioral treatment for sleep difficulties	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD
Estimated Study Start Date :	October 2020
Estimated Primary Completion Date :	September 2022
Estimated Study Completion Date :	September 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Autism spectrum disorder

U.S. FDA Resources

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Months to 5 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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:

None

Contacts and Locations

No Contacts or Locations Provided

More Information

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Responsible Party:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT04539990
Other Study ID Numbers:	sor 0266-20 ctil
First Posted:	September 7, 2020 Key Record Dates
Last Update Posted:	September 7, 2020
Last Verified:	August 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Dyssomnias Parasomnias Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive	Neurodevelopmental Disorders Mental Disorders Sleep Wake Disorders Nervous System Diseases

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