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

NCT03668873 | Completed Results

• 1 other identifier: AR170155
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Sleep Disturbance

Keywords

Parent Training; Telehealth; Sleep Problems

Outcome Measures

Primary Outcomes (2)

• Change From Baseline on MSPSQ-CSI

  Modified Simonds \& Parraga Sleep Questionnaire-Composite Sleep Index (MSPSQ - CSI). The modified version of the Simonds \& Parraga Sleep Questionnaire (MSPSQ6 was completed by the child's primary caregiver at baseline, and weeks 5 and 10 weeks for both groups. We used earlier described conventions for determining the MSPSQ - CSI score. The CSI was calculated by assigning a score to the frequency of sleep problems targeted: bedtime resistance (item 5), night waking (item 10), early waking (item 51) and sleeping in places other than bed (item 35). In addition, scores were assigned for the duration of sleep latency (item 6) and night wakings (item 12). Minimum score of 0 and maximum score of 12, higher score indicated worse outcome. The sample sizes reflect the number of participants who completed surveys at each follow-up.

  Baseline, 5 weeks, and 10 weeks

• Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale

  Improvement scale of the Clinical Global Impression (CGI-I) Scale is a clinician-rated, 7-point scale designed to measure overall improvement from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). An IE masked to group assignment used all available information to judge treatment response. CGI-I ratings of Much Improved (score of 2) or Very Much Improved (score of 1) were used to classify subjects as positive responders. All other scores classify subjects as negative responders. Subjects who dropped out or had missing data were classified as negative responders.

  10 weeks

Secondary Outcomes (3)

• Change in ABC- Irritability From Baseline

  Baseline, 5 weeks, and 10 weeks

• Change in PSI From Baseline

  baseline, 5 weeks, and 10 weeks

• PSOC Change From Baseline

  Baseline, 5 week, 10 weeks

Other Outcomes (1)

• Treatment Fidelity

  10 weeks

Study Arms (2)

Sleep Parent Training

EXPERIMENTAL

The five SPT sessions (each 60-90 minutes in duration) are individually delivered over 10-week virtually (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

Sleep Parent Education

ACTIVE COMPARATOR

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

Interventions

Sleep Parent Training BEHAVIORAL

SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.

Sleep Parent Training

Sleep Parent Education BEHAVIORAL

SPE is a structured program intended to mimic treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.

Sleep Parent Education

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).
• Children with a psychiatric disorder or serious behavioral problems requiring immediate treatment.
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• United States Department of Defense: collaborator

Study Sites (1)

Cleveland Clinic Centerl for Autism

Cleveland, Ohio, 44104, United States

Location

Related Publications (2)

• 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.

  PMID: 23993773 RESULT

• Johnson CR, Barto L, Worley S, Rothstein R, Alder ML. Telehealth parent training for sleep disturbances in young children with autism spectrum disorder: A randomized controlled trial. Sleep Med. 2023 Nov;111:208-219. doi: 10.1016/j.sleep.2023.08.033. Epub 2023 Sep 12.

  PMID: 37806263 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Parasomnias

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

In designing the trial for telehealth delivery, we did not include some measures we might have if the study was in-person. For example, we did not have cognitive or language measures. These could also be treatment moderators in a larger study. We also did not include a measure of anxiety which is a likely predictive for treatment response. Further absent were measures of repetitive / restrictive behaviors or sensory sensitivities; both domains may influence response to the intervention.

Results Point of Contact

• Title: Cynthia R. Johnson, PhD
• Organization: Cleveland Clinic Foundation

johnsoc@ccf.org

216 448-6440

Study Officials

• Cynthia R Johnson, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Autism; Professor

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 13, 2018
• Study Start: November 1, 2018
• Primary Completion: November 20, 2022
• Study Completion: December 26, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)