Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

ConditionInsomnia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-7

SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Sleep Parent Training (SPT)
Behavioral
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)
Behavioral
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.

Treatment groups

130 Participants

are divided into 2 treatment groups

Group A: Sleep Parent Treatment (SPT)Experimental treatment 1 intervention

Group B: Sleep Parent Education (SPE)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline, Week 5, Week 10

Secondary outcomes

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.

Time frame

Week 10

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Ohio State University