A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

NCT ID: NCT04539990

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral treatment for sleep difficulties

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

None

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

sor 0266-20 ctil

Identifier Type: -

Identifier Source: org_study_id