Online sleep program for parents of young autistic children with insomnia
Tests two parent-led sleep programs delivered online for young autistic children with insomnia.
Key facts
- Who runs it
- The Cleveland Clinic
- Where
- Cleveland and Columbus, United StatesSee the 3 sites
- Trial code
- Registry title
- Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
- Status
- Recruiting
- People taking part
- 130 people, planned
- Started
- 5 Jun 2026
- Expected to end
- Jan 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sleep Parent Training (SPT)
- Sleep Parent Education (SPE)
- Record updated
- 8 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for autistic children aged 3 to 7 years 11 months who have insomnia. Parents lead a 10-week sleep program by telehealth.
- Age
- Older than 3 years up to 7 years 11 months
- Sex
- All sexes can join.
- Disease stage
- Autism diagnosis confirmed with the ADI-R. Insomnia score of 30 or more on the PAIRS and a CGI-S score of 4 or more (moderate or greater).
- Earlier treatment
- Children take no medication or supplements, or are on stable ones. No changes in the past 6 weeks and none planned for the 10 weeks of the trial.
Main reasons for not taking part
- Serious medical condition or known medical cause of insomnia, such as nocturnal seizures or unresolved reflux or constipation
- Psychiatric disorder or serious behavioral problem needing a different treatment
- Known sleep apnea, restless leg syndrome, periodic limb movements during sleep, or a circadian-based sleep disorder
- Caregivers who do not speak and write English well
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Age >3 to 7 years 11 months
- Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)
- Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (a score of 4 or more)
- Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the randomized trial)
- Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English
Who cannot take part
- Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation)
- Children with a psychiatric disorder or serious behavioral problem requiring a different treatment
- Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
- Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only available in English
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 7 years old?
Where in United States
- Case Western Reserve UniversityCleveland, United StatesContact: Cynthia Johnson, PhDTaking people
- Cleveland Clinic Children's Center for AutismCleveland, United StatesContact: Cynthia R Johnson, PhDTaking people
- Ohio State UniversityColumbus, United StatesContact: Cynthia Johnson, PhDTaking people
About the trial
What the trial wants to find out
This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be randomly assigned to either the SPT or SPE intervention for 10 weeks.
The 2 groups in the trial
- Sleep Parent Treatment (SPT)Treatment being tested
Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Treatment (SPT) delivered over 10 weeks.
Treatment: Sleep Parent Training (SPT)
- Sleep Parent Education (SPE)Existing treatment, for comparison
Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Education (SPE) delivered over 10 weeks.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
- Plain-language title
- Online sleep program for parents of young autistic children with insomniaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07435740, who can take part
- Record updated
- 8 October 2026