Improving sleep for caregivers of children with autism and insomnia
Pilot RCT to Compare a Home Based Tailored Cognitive Behavioral Therapy for Insomnia (CBT-I) Versus Webased CBT-I to Improve Sleep in Caregivers With Insomnia in the Context of Caring for a Child With Autism Spectrum Disorder
This study is testing two different sleep improvement programs for caregivers of children with autism and insomnia to see which one helps them sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 3 Years to 100 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT05373537 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare two interventions designed to improve sleep in caregivers who have insomnia while caring for a child with Autism Spectrum Disorder (ASD) and insomnia. Participants will be assigned to either a home-based cognitive behavioral therapy for insomnia (CBT-I) or a web-based CBT-I intervention. The study will assess the feasibility, acceptability, and efficacy of these approaches, as well as explore the relationships between caregiver and child sleep patterns, caregiver mental health, and child behavior. The findings will help inform a larger randomized controlled trial in the future.
Who should consider this trial
Good fit: Ideal candidates include caregivers aged 18 or older who have insomnia and care for a child aged 3 to 17 years diagnosed with Autism Spectrum Disorder and insomnia.
Not a fit: Patients who do not have insomnia or do not care for a child with Autism Spectrum Disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the sleep quality and overall well-being of caregivers, leading to better care for their children with autism.
How similar studies have performed: Other studies have shown success with cognitive behavioral therapy for insomnia, particularly in caregiver populations, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Caregiver with a child with ASD: * Caregiver age 18 years or older * Diagnosis of Insomnia * Parental/guardian will give permission (informed consent) for child * Telephone and web Access * Stable medical and behavioral conditions, with no change in health status in the past three months * Commitment to maintaining stable medication doses and keeping medication consistent Inclusion Criteria for Children with ASD: * Children age 3 to 17 years and one of their parents * Diagnosis of Autism Spectrum Disorders, confirmed with Autism Diagnostic Observation Schedule and/or DSM-IV criteria. * Diagnosis of Behavioral Insomnia or Insomnia due to ASD (Insomnia due to internal * Parental/guardian permission (informed consent) and if appropriate, child assent. * Telephone and web Access * Stable medical and behavioral conditions, with no change in health status in the past * Commitment to maintaining stable medication doses and keeping child's sleep medication consistent Key exclusion criteria for Caregiver and child with ASD: * Insomnia due to co-occurring medical conditions and/ or sleep disorders such as obstructive sleep apnea (OSA), narcolepsy, restless leg syndrome, severe reflux, nocturnal asthma * Unstable co-occurring medical conditions such as epilepsy or other neurological disorders, sickle cell anemia, diabetes or severe eczema * Significant hearing or vision loss * Known genetic disorders such as Fragile X, 22ql 1.2 Deletion Syndrome, Rett Disorder, Down Syndrome. * Subjects who, in the opinion of the Investigator, may be non¬ compliant with study schedules or procedures.
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Margaret C Souders
- Email: vivien@upenn.edu
- Phone: 484-432-6538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.