Status:
ACTIVE_NOT_RECRUITING
Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Autism Spectrum Disorder
Insomnia Chronic
Eligibility:
All Genders
3-100 years
Phase:
NA
Brief Summary
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...
Detailed Description
Overall objectives The investigators propose to compare a home-based tailored CBT-I intervention versus a web-based Way to Health (WTH) platform tailored CBT-I intervention for caregivers with insomn...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05373537
Start Date
November 5 2022
End Date
December 15 2025
Last Update
June 26 2025
Active Locations (2)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19041
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104