A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

NCT04539990 | Unknown

• 1 other identifier: sor 0266-20 ctil
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism; Autism Spectrum Disorder; Sleep

Outcome Measures

Primary Outcomes (2)

• Child Sleep Habits Questionnaire

  Parent questionnaire regarding sleep habits of their child

  8 weeks after program begins

• Night time sleep as measured by Fitbit sensor

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

  8 weeks after program begins

Study Arms (1)

Behavioral Sleep Treatment

EXPERIMENTAL

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

Interventions

Behavioral treatment for sleep difficulties BEHAVIORAL

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.

Behavioral Sleep Treatment

Eligibility Criteria

• Age: 18 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: September 7, 2020

Record last verified: 2020-08