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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03668873
• Other study ID #: AR170155
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Lerner School for Autism	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (1)

Johnson CR, Turner KS, Foldes E, Brooks MM, Kronk R, Wiggs L. Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder: a pilot trial. Sleep Med. 2013 Oct;14(10):995-1004. doi: 10.1016/j.sleep.2013.05.013. Epub 2013 Aug 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Sleep Disturbances	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).	Baseline and 10 weeks
Secondary	Parental Quality of Life: PSOC	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.	Baseline and 10 weeks