A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Sleep Habits Questionnaire
Time Frame: 8 weeks after program begins
|
Parent questionnaire regarding sleep habits of their child
|
8 weeks after program begins
|
|
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
|
8 weeks after program begins
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sor 0266-20 ctil
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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