NCT05373537Active, not recruiting
Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism
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
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 11 Apr 2022
- Start date
- 5 Nov 2022
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- University of Pennsylvania
- Diseases
- Autism
- NCT number
- NCT05373537
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 5 Nov 2022 to the primary completion date, 15 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Known genetic disorders such as Fragile X, 22ql 1.2 Deletion Syndrome, Rett Disorder, Down Syndrome.
Other
- Significant hearing or vision loss
- Subjects who, in the opinion of the Investigator, may be non¬ compliant with study schedules or procedures.
Who the study is looking for
- 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
- 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
Age in the registry: 3 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.