Clinical trial NCT03668873: Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
Official title: Telehealth Delivery of Treatment for Sleep Disturbances in Young Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Sleep Disturbance
Keywords: Parent Training
Telehealth
Sleep Problems
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2018-09-13
Enrollment: 91
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline on MSPSQ-CSI
timeFrame: Baseline, 5 weeks, and 10 weeks
measure: Percentage of Treatment Responders at Week 10 Using Clinical Global Impression (CGI-I) Scale
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in ABC- Irritability From Baseline
timeFrame: Baseline, 5 weeks, and 10 weeks
measure: Change in PSI From Baseline
timeFrame: baseline, 5 weeks, and 10 weeks
measure: PSOC Change From Baseline
timeFrame: Baseline, 5 week, 10 weeks
Other outcomes:
measure: Treatment Fidelity
timeFrame: 10 weeks
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Centerl for Autism
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Cynthia R Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.