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Behavioral Intervention

Cognitive Behavioral Therapy for Caregiver Insomnia

N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Behavioral Insomnia or Insomnia due to ASD (Insomnia due to internal
Children age 3 to 17 years and one of their parents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8
Awards & highlights

Study Summary

This trial will focus on improving sleep for caregivers of children with ASD and insomnia by comparing a home-based tailored CBT for Insomnia (CBT-I) intervention to a web-based Way to Health CBT-I intervention.

Who is the study for?
This trial is for caregivers over 18 years old with insomnia, who are caring for a child aged 3-17 with Autism Spectrum Disorder. Participants must have telephone and web access, agree to keep their child's medication doses stable, and provide consent for the child.Check my eligibility
What is being tested?
The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I) tailored to caregivers of children with autism. It compares home-based CBT-I against a web-based program to see which improves sleep quality better.See study design
What are the potential side effects?
Since this trial involves therapy rather than medication, traditional side effects are not expected. However, participants may experience temporary increases in stress or anxiety as they adjust to new sleep routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with insomnia related to behavior or autism.
Select...
I am a child aged 3-17 or their parent.
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I have been diagnosed with insomnia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Caregiver Acceptability Opinion Survey
Feasibility of pilot study
Secondary outcome measures
Change in Caregiver behaviors
Change in Child Daytime behaviors
Change in Maternal Self-efficacy
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: web-basedExperimental Treatment1 Intervention
web-based CBT-Insomnia intervention
Group II: Home-basedExperimental Treatment1 Intervention
home- based CBT-Insomnia intervention

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,129 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,580,979 Total Patients Enrolled

Media Library

Cognitive behavioral therapy for Insomnia (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05373537 — N/A
Chronic Insomnia Research Study Groups: web-based, Home-based
Chronic Insomnia Clinical Trial 2023: Cognitive behavioral therapy for Insomnia Highlights & Side Effects. Trial Name: NCT05373537 — N/A
Cognitive behavioral therapy for Insomnia (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373537 — N/A
Chronic Insomnia Patient Testimony for trial: Trial Name: NCT05373537 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric participants able to enter this experiment?

"According to the official requirements, this trial is available for those between 3 and 100 years old. There are 247 trials open specifically for minors and 258 studies targeting seniors."

Answered by AI

What is the aggregate figure of individuals who have signed up for participation in this experiment?

"Affirmative. Information from clinicaltrials.gov suggests that this medical investigation is actively enrolling patients, with the initial post published on September 26th 2022 and last updated on September 21st 2022. 80 participants are needed at a single centre for completion of the trial."

Answered by AI

What is the primary purpose of this clinical trial?

"The primary assessment of this clinical trial, over a 8 week period, will be the feasibility of pilot study. Secondary measurements include Change in Maternal Self-efficacy (via the 10 item Maternal-Self efficacy Scale with a minimum score of 10 and maximum 40), Change in Child Daytime behaviours (using T scores from 0 to 100 on the Child Behavior Checklist) and Change in wake after sleep onset as monitored by an actigraphy watch for caregivers (measured using average minutes per week)."

Answered by AI

Are there any opportunities to participate in this experimental program?

"The clinical trial is currently seeking participants, as per the details available on clinicaltrials.gov; it was initially posted on September 26th 2022 and last updated on September 21st 2022."

Answered by AI

What type of individuals are suitable candidates for this clinical experiment?

"This study seeks 80 minors between the ages of 3 and 100 as well as their caregivers. To qualify, patients must also meet a set of criteria: Caregivers must be 18 years or older; Diagnosis of Insomnia is necessary; Both parental/guardian permission (informed consent) for child participation and telephone/web access are mandatory; Maintenance of stable medication doses with no change in health status within the past three months is essential; For children age 3 to 17 years there needs to be diagnosis confirmation with either Autism Diagnostic Observation Schedule or DSM-IV criteria.; Stable medical and behavioural conditions are needed."

Answered by AI

Who else is applying?

What state do they live in?
New York
Pennsylvania
Oregon
How old are they?
18 - 65
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

I live in Eugene, OR - is this online?
PatientReceived no prior treatments

Why did patients apply to this trial?

I am struggling with my child.
PatientReceived 1 prior treatment
~11 spots leftby Aug 2024