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Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03668873
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : July 7, 2020
United States Department of Defense
Information provided by (Responsible Party):
Cynthia Johnson, The Cleveland Clinic

Brief Summary:
Study Design: Ninety children with Autism Spectrum Disorder (ASD), between the ages of 2 to less than 7 years, and their parents will be recruited for this 10 week randomized clinical trial. Participants will be randomized to five individually delivered sessions of Sleep Parent Training (SPT) or five individually delivered sessions of Sleep Parent Education (SPE). Delivery of the programs will be via telehealth platform which also includes parent-child coaching in real-time. In addition to baseline, outcome measures will be collected at week 5 (midpoint of trial) and week 10 (endpoint of trial) as well as follow-up at week 16 to determine durability of treatment.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Sleep Disturbance Behavioral: Sleep Parent Training Behavioral: Sleep Parent Education Not Applicable

Detailed Description:

This study will deliver an already initially tested manualized parent training program specially targeting bedtime and sleep disturbances, but delivered via telehealth platform and enhancing the program using live parent coaching at bedtime. Utilizing REDCap automated survey invitations feature, investigators will provide reminders of the intervention recommendations and data collection requirements. In a randomized clinical trial of 90 children with ASD, ages 2 to less than 7 years, a parent training program targeting sleep disturbance (Sleep Parent Training; SPT), will be compared to Sleep Parent Education (SPE). The investigators hypothesize that SPT will be superior in improving child sleep, child daytime functioning as well as parent well-being compared to SPE.

Specific Aims: Aim 1. To evaluate the efficacy of Sleep Parent Training program (SPT) delivered via telehealth for sleep disturbances compared Sleep Parent Educational Program (SPE, time and attention control) also delivered via telehealth in 90 children with ASD (ages >2 to <7 years) with moderate or greater sleep disturbances as measured by the Composite Sleep Index (CSI) of the modified Simonds and Parraga Sleep Questionnaire (MSPSQ).97 Aim 2. To evaluate the impact of SPT on child and parent quality of life (daytime child behavior, parental stress, parent sense of competency, mental health) compared to SPE.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sleep Parent Training
The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-weeks. In addition to the five sessions, there are three home visits conducted via Express Care Online (HIPAA compliant video-chat). After Session A, session order may be adjusted to address child-specific problems. One-on-one delivery of SPT permits flexibility for child-specific problems within the program.
Behavioral: Sleep Parent Training
SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.

Active Comparator: Sleep Parent Education
SPE consists of five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and sleep problems. Session A is designed to develop rapport. The sleep hygiene session (Session B) has been modeled from the RUBI manual. The other sessions include a systematic presentation on several relevant topics. An example of a SPE session is provided in the Intervention section. This condition is intended to parallel what would be offered in typical care, but by telehealth, where a parent might be educated about ASD as well as attend an outpatient appointment at a sleep clinic.
Behavioral: Sleep Parent Education
SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.

Primary Outcome Measures :
  1. Improvement in Sleep Disturbances [ Time Frame: Baseline and 10 weeks ]

    After 10 weeks of treatment, children whose parents receive SPT will show greater improvement in sleep as evidenced by reduction on the Composite Sleep Index (CSI) of the modified Simonds and Parraga Sleep Questionnaire and will show significantly reduced disruptive behavior on the parent-rated Irritability subscale of the Aberrant Behavior Checklist (ABC) compared to children whose parents receive SPE.

    CSI is a 6-item parent-report measure where items are rated 0 to 2 (range 0 to 12) with higher scores reflecting greater sleep problems. Thus, change in an item score of 1 or 2 points reflects a clinically relevant change. ABC is a 58-item parent-report questionnaire with five subscales: Irritability, Social Withdrawal, Stereotyped Behaviors, Hyperactivity, and Inappropriate Speech each item is rated on a Likert scale from 0 (not a problem) to 3 (severe in degree).

Secondary Outcome Measures :
  1. Parental Quality of Life: PSOC [ Time Frame: Baseline and 10 weeks ]

    After 10 weeks of treatment, parents enrolled in SPT will report lower levels of stress and higher levels of competency and health as measured by the Parenting Stress Index (PSI), Parenting Sense of Competence (PSOC), and Parent Health Questionnaire (PHQ) compared to parents in SPE.

    PSI is is a 36-item parent-completed questionnaire for children 12 years of age and younger and has three scales: 1) Parental Distress; 2) Difficult Child Characteristics; and, 3) Dysfunctional Parent-Child Interaction. A total score of 88 (85th percentile) and above is considered in the clinically significant range for parental stress. PSOC is 17-item scale was developed to assess parental self-efficacy. Each item is answered on a 6-point scale ranging from strongly disagree to strongly agree, PSOC also yields a Total Competence score, with higher scores reflecting higher competence. PHQ is a brief self-report is designed to assess parental mental health.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Both genders >2 and <7 years of age
  2. Clinical diagnosis of ASD corroborated by the Modified Checklist for Autism in Toddlers169 or the Social Communication Questionnaire.170
  3. Score of >5 on the CSI and a Clinical Global Impression Severity (CGI-S) score of Moderate or greater.
  4. Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 16 weeks).
  5. Parental proficiency in spoken and written English language.

Exclusion Criteria:

  1. Children with a serious medical condition or a known or suspected medical cause for sleep disturbances (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation).
  2. Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment.
  3. Children with known or suspected sleep apnea, restless legs, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g. delayed or advanced sleep phase syndrome) based on history and all available information.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03668873

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Contact: Destiny Kaznoch, BS 216-448-6392
Contact: Mallori King, BA 216-448-6612

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United States, Ohio
Cleveland Clinic Lerner School for Autism Recruiting
Cleveland, Ohio, United States, 44104
Contact: Destiny Kaznoch, BS         
Sponsors and Collaborators
The Cleveland Clinic
United States Department of Defense
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Principal Investigator: Cynthia Johnson, PhD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Cynthia Johnson, The Cleveland Clinic:
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Responsible Party: Cynthia Johnson, Director Center for Autism, The Cleveland Clinic Identifier: NCT03668873    
Other Study ID Numbers: AR170155
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cynthia Johnson, The Cleveland Clinic:
Parent Training
Sleep Problems
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases