NCT04539990

A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Months – 5 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2020-09-07
• Last updated: 2020-09-07