InsomniaNCT07435740
Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
A study testing Sleep Parent Training (SPT) and Sleep Parent Education (SPE) in people with Insomnia, run by The Cleveland Clinic at 3 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Sleep Parent Training (SPT) and Sleep Parent Education (SPE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Jun 2026to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cleveland Clinic Children's Center for Autism
Cleveland, Ohio, 44104
Cynthia R Johnson, PhD, 216-448-6392, autismresearch@ccf.org
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
- Recruiting
Ohio State University
Columbus, Ohio, 43210
About this study
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.
Read the detailed description
In the general pediatric population, insomnia affects an estimated 20-25% of children, however, insomnia affects as many as 40-80% of children with autism spectrum disorder (ASD).
Insomnia is characterized by problems of initiating sleep and/or maintaining sleep occurring three or more nights per week for more than three months accompanied by distress, impairment or both. The diagnostic criteria stipulate that the sleep problem is not attributable to another cause (e.g., restless legs syndrome, caffeine intake). In autistic children, insomnia may interfere with concentration and learning, may contribute to daytime sleepiness, disruptive daytime behavior, emotion dysregulation and physical injury. The child's bedtime behavior and sleep disturbances may also interfere with sleep for caregivers or other family members and predict elevated parental stress. Chronic insomnia in children may have detrimental effects on cardiovascular, endocrine or immune systems. Parents of autistic children with insomnia consistently report that the child's bedtime resistance behaviors may be difficult to manage.
Accumulated data indicate that parent-mediated behavioral interventions for insomnia can be effective, however, only a few randomized controlled trials have rigorously tested parent-mediated behavioral interventions for insomnia in autistic children. A recently completed telehealth trial compared two behavioral interventions and found that Sleep Parent Treatment (SPT) was superior to Sleep Parent Education (SPE) for improving child sleep outcomes, parental self-efficacy and parental distress. Although encouraging, the sample size of this study provided limited exploration of treatment moderators. The researchers now propose a large-scale, definitive study of telehealth SPT versus individualized, menu-driven SPE.
In this study, autistic children with at least moderate insomnia will be randomly assigned to SPT or SPE for 10 weeks. The primary outcome is the parent-rated PAIRS, a newly validated, continuous measure assessing insomnia severity in children with ASD. It will be collected at baseline, midpoint (Week 5) and endpoint (Week 10) in the randomized phase.
Longitudinal differences in PAIRS between randomized groups will be tested for significance using a general linear mixed effects regression model (GLMM). The GLMM will use data from all study time points and report on the baseline-adjusted least-squares mean (LS-mean) difference in PAIRS at Week 10 for SPT compared to SPE, with 95% confidence interval (CI) and p-value. The researchers will follow intention-to-treat (ITT) principles throughout, analyzing participants according to originally assigned groups, regardless of what treatment they received (if any) or attrition.
- Conditions
- Insomnia
- Being tested
- Sleep Parent Training (SPT), Sleep Parent Education (SPE)
- Keywords
- autism
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Parent Training (SPT)Behavioural
Five SPT sessions, each 60-90 minutes in duration, are individually delivered over 10 weeks. Each session employs direct instruction, modeling, and role-playing to promote parental skill acquisition. The SPT manual includes a therapist script and parent activity sheets for each session. Video vignettes for each session model specific techniques, including correct application of a technique and ineffective strategies. To supplement the 5 sessions, three virtual parent-child coaching sessions occur to ensure implementation fidelity. A sleep plan for the child is developed with the parent and is revised, as needed, at each session.
Sleep Parent Education (SPE)Behavioural
SPE includes five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and insomnia. The sessions cover a review of autism, sleep hygiene, interpretation of clinical evaluations, child advocacy and evaluation of available treatments, and information on evidence-based treatments.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Parent Treatment (SPT) | Experimental | Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Treatment (SPT) delivered over 10 weeks. Receives: Behavioral: Sleep Parent Training (SPT) |
| Sleep Parent Education (SPE) | Active comparator | Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Education (SPE) delivered over 10 weeks. Receives: Behavioral: Sleep Parent Education (SPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Autism Insomnia Scale (PAIRS) Score
Insomnia severity is assessed with the Pediatric Autism Insomnia Scale (PAIRS) instrument. The PAIRS is a 21- item measure designed to capture the frequency and impact of insomnia (e.g., trouble initiating or maintaining sleep) in autistic children. Responses to items are scored on a 4-point scale, ranging from 0 to 3. Example of items are "My child has a bedtime routine; small changes throw it off" and "My child has a hard time settling down to fall asleep at night." Total scores range from 0 to 63, with higher score reflecting greater severity of insomnia symptoms. A score of >30 is required for study entry.
Measured: Baseline, Week 5, Week 10
Secondary outcomes (1)
Rate of Positive Response on the Clinical Global Impression - Improvement (CGI-I) Scale
The Clinical Global Impression - Improvement (CGI-I) Scale is a clinician-rated, 7-point scale designed to measure overall change from baseline. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). Sleep problems will be weighted in the assessment of the CGI-I, but blinded independent evaluators will consider all aspects of the child's status to assign the CGI-I score. In this study, a positive response is defined as a response of Much Improved or Very Much Improved.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Jun 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio State University
- Responsible party
- Principal investigator, Cynthia Johnson, The Cleveland Clinic
- Investigators
- Luc Lecavalier, PhD, Principal investigator, Ohio State UniversityCynthia R Johnson, Principal investigator, Cleveland Clinic Center for Autism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435740
- Sponsor's protocol ID
- 2025P013830
- Other IDs
- R01HD114631
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children
- ClinicalTrials.gov ID
- NCT07435740
- Acronym / sponsor ID
- 2025P013830
- Conditions
- Insomnia
- Keywords
- autism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ohio State University
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the general pediatric population, insomnia affects an estimated 20-25% of children, however, insomnia affects as many as 40-80% of children with autism spectrum disorder (ASD).
Insomnia is characterized by problems of initiating sleep and/or maintaining sleep occurring three or more nights per week for more than three months accompanied by distress, impairment or both. The diagnostic criteria stipulate that the sleep problem is not attributable to another cause (e.g., restless legs syndrome, caffeine intake). In autistic children, insomnia may interfere with concentration and learning, may contribute to daytime sleepiness, disruptive daytime behavior, emotion dysregulation and physical injury. The child's bedtime behavior and sleep disturbances may also interfere with sleep for caregivers or other family members and predict elevated parental stress. Chronic insomnia in children may have detrimental effects on cardiovascular, endocrine or immune systems. Parents of autistic children with insomnia consistently report that the child's bedtime resistance behaviors may be difficult to manage.
Accumulated data indicate that parent-mediated behavioral interventions for insomnia can be effective, however, only a few randomized controlled trials have rigorously tested parent-mediated behavioral interventions for insomnia in autistic children. A recently completed telehealth trial compared two behavioral interventions and found that Sleep Parent Treatment (SPT) was superior to Sleep Parent Education (SPE) for improving child sleep outcomes, parental self-efficacy and parental distress. Although encouraging, the sample size of this study provided limited exploration of treatment moderators. The researchers now propose a large-scale, definitive study of telehealth SPT versus individualized, menu-driven SPE.
In this study, autistic children with at least moderate insomnia will be randomly assigned to SPT or SPE for 10 weeks. The primary outcome is the parent-rated PAIRS, a newly validated, continuous measure assessing insomnia severity in children with ASD. It will be collected at baseline, midpoint (Week 5) and endpoint (Week 10) in the randomized phase.
Longitudinal differences in PAIRS between randomized groups will be tested for significance using a general linear mixed effects regression model (GLMM). The GLMM will use data from all study time points and report on the baseline-adjusted least-squares mean (LS-mean) difference in PAIRS at Week 10 for SPT compared to SPE, with 95% confidence interval (CI) and p-value. The researchers will follow intention-to-treat (ITT) principles throughout, analyzing participants according to originally assigned groups, regardless of what treatment they received (if any) or attrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Parent Treatment (SPT) | Experimental | Behavioral: Sleep Parent Training (SPT)Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Treatment (SPT) delivered over 10 weeks. |
| Sleep Parent Education (SPE) | Active comparator | Behavioral: Sleep Parent Education (SPE)Autistic children with moderate or greater insomnia who are randomly assigned to receive 5 sessions of Sleep Parent Education (SPE) delivered over 10 weeks. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Parent Training (SPT)Five SPT sessions, each 60-90 minutes in duration, are individually delivered over 10 weeks. Each session employs direct instruction, modeling, and role-playing to promote parental skill acquisition. The SPT manual includes a therapist script and parent activity sheets for each session. Video vignettes for each session model specific techniques, including correct application of a technique and ineffective strategies. To supplement the 5 sessions, three virtual parent-child coaching sessions occur to ensure implementation fidelity. A sleep plan for the child is developed with the parent and is revised, as needed, at each session. | Behavioural | Sleep Parent Treatment (SPT) |
| Sleep Parent Education (SPE)SPE includes five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and insomnia. The sessions cover a review of autism, sleep hygiene, interpretation of clinical evaluations, child advocacy and evaluation of available treatments, and information on evidence-based treatments. | Behavioural | Sleep Parent Education (SPE) |
Primary outcome
Pediatric Autism Insomnia Scale (PAIRS) Score
Time frame: Baseline, Week 5, Week 10
Insomnia severity is assessed with the Pediatric Autism Insomnia Scale (PAIRS) instrument. The PAIRS is a 21- item measure designed to capture the frequency and impact of insomnia (e.g., trouble initiating or maintaining sleep) in autistic children. Responses to items are scored on a 4-point scale, ranging from 0 to 3. Example of items are "My child has a bedtime routine; small changes throw it off" and "My child has a hard time settling down to fall asleep at night." Total scores range from 0 to 63, with higher score reflecting greater severity of insomnia symptoms. A score of >30 is required for study entry.
1 secondary outcome
Rate of Positive Response on the Clinical Global Impression - Improvement (CGI-I) Scale
Time frame: Week 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luc Lecavalier, PhD principal investigator
Ohio State University
Cynthia R Johnson principal investigator
Cleveland Clinic Center for Autism
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Parent Training (SPT) and Sleep Parent Education (SPE) in people with Insomnia, run by The Cleveland Clinic at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Johnson, PhD ((216) 448-6440, johnsoc@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Autism Insomnia Scale (PAIRS) Score (time frame: Baseline, Week 5, Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.