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A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

Primary Purpose

Autism, Autism Spectrum Disorder, Sleep

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Behavioral treatment for sleep difficulties
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

18 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Behavioral Sleep Treatment

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Child Sleep Habits Questionnaire
    Parent questionnaire regarding sleep habits of their child
    Night time sleep as measured by Fitbit sensor
    Sensor is placed on the arm of the child for 5 days and measures sleep

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2020
    Last Updated
    August 31, 2020
    Sponsor
    Soroka University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04539990
    Brief Title
    A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD
    Official Title
    A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism, Autism Spectrum Disorder, Sleep

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Behavioral Sleep Treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavioral treatment for sleep difficulties
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Child Sleep Habits Questionnaire
    Description
    Parent questionnaire regarding sleep habits of their child
    Time Frame
    8 weeks after program begins
    Title
    Night time sleep as measured by Fitbit sensor
    Description
    Sensor is placed on the arm of the child for 5 days and measures sleep
    Time Frame
    8 weeks after program begins

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Months
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

    A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD

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