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NCT05373537 · ClinicalTrials.gov registry record · NA
Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism
A NA study of Autism Spectrum Disorder and Caregiver Burden, sponsored by University of Pennsylvania.
- Active
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT05373537: Active NA study of Autism Spectrum Disorder and Caregiver Burden, sponsored by University of Pennsylvania.
NCT05373537 is a NA study of Autism Spectrum Disorder and Caregiver Burden that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 80 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (41% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05373537, a NA study of Autism Spectrum Disorder and Caregiver Burden, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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 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.
Primary Outcome
Opinion Survey with 8 items rated on a 7- point Likert scale. minimum of 0 and max of 56 with a score of 40 or greater will be considered acceptable for this study.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive behavioral therapy for Insomnia
Study Locations (2)
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-11-05 |
| Est. Completion | 2025-12-15 |
| Phase | NA |
What the registry record for NCT05373537 still lists
NCT05373537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (41% lower).
The record links to 3 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Cognitive behavioral therapy for Insomnia is the first listed.
NCT05373537 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05373537 about?
NCT05373537 is a clinical study titled "Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism". 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 e...
What is the current status of trial NCT05373537?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2022-11-05. Estimated completion is 2025-12-15.
What conditions does trial NCT05373537 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Caregiver Burden, Insomnia Chronic.
What interventions are being tested in trial NCT05373537?
The interventions under investigation include: Cognitive behavioral therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT05373537?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05373537 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05373537's enrollment target sits among peer trials
80 89th of 224 higher than 126 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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