A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04539990
• Other study ID #: sor 0266-20 ctil
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: September 2023

Study information

• Verified date: August 2020
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder
• Dyssomnias
• Parasomnias
• Sleep

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Sleep Habits Questionnaire	Parent questionnaire regarding sleep habits of their child	8 weeks after program begins
Primary	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