- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05588739
Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA) (COMAA)
June 16, 2023 updated by: University of Oklahoma
Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk
Youth suicide risk has increased 56% in the last decade, and suicide is the leading cause of preventable death in children and adolescents.
Experiencing chronic nightmares doubles the risk of suicidal ideation in children and adolescents.
Decades of research support that even when controlling for depression and insomnia, nightmares predict suicidality.
Contemporary theories model nightmares as the mediating link between depression and suicide.
Numerous studies examine the effect of nightmare-specific therapies on reducing suicide in adults, but none have examined whether nightmare therapies can reduce youth suicidality.
The proposed pilot will evaluate the feasibility of the Cognitive Behavioral Therapy for Nightmares in Children paradigm (CBT-NC), recruiting and retaining children ages 6-17 who experience chronic nightmares.
Utilizing a waitlist control (WL) model, participants (n=30) will be randomized after baseline assessment to either immediate treatment or a WL.
Feasibility will be evaluated by examining retention through treatment (or WL) to post WL and post treatment assessments.
Both groups will be evaluated before and after the treatment for suicidal ideation, sleep quality, and nightmare distress and frequency, in order to document improvements due to therapy.
The proposed pilot will provide preliminary data about recruitment, retention, and allow for effect size calculations between groups.
These results will be used to develop a larger treatment study that would ultimately evaluate the mediating effect of treatment for chronic nightmares on suicidality in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa M Cromer, PhD
- Phone Number: 918-631-3982
- Email: lisa-cromer@utulsa.edu
Study Contact Backup
- Name: Tara R Buck, MD
- Phone Number: 918-660-3511
- Email: tara-buck@ouhsc.edu
Study Locations
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Oklahoma
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Tulsa, Oklahoma, United States, 74135
- University of Oklahoma School of Community Medicine
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Tulsa, Oklahoma, United States, 74104
- University of Tulsa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Child must be between the ages of 6-17 years 11 months.
- Child must report recurrent nightmares that meet DSM criteria for nightmare disorder.
- Child must speak and understand English at no less than a 6 year old level.
- Children on prescribed psychotropic medications must be stable for 30 days prior to enrolling.
- Child must have a parent or legal guardian attend study visits with them.
- Participants must have access to WIFI/phone data in order to participate in this study, and must have an electronic device with a camera enabled. Our study team will have the capability of driving a tablet to the participant's home if that is the only reason they cannot participate, and if the family lives within the greater Tulsa area.
Exclusion Criteria:
- Children with a previous diagnosis of sleep apnea which is not adequately treated.
- Children whose receptive/expressive language skills are below a 6 year old level.
- If it is determined that a child is actively suicidal and at imminent risk for self-harm, the family will be notified and referred for immediate care. They will not be eligible for the study until they are deemed stable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Right-Away
Cognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
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The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
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No Intervention: Waitlist Control
Waitlist control group will complete pre and post assessments at beginning and end of wait period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
Time Frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
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Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)
Time Frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
|
The TRNS-C is a 14 item self report questionnaire that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.
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Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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Change on Sleep Locus of Control (SLOC)
Time Frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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The SLOC is an 6 item self report measure perceived contingencies between sleep behavior and events.
This scale is collected as a child self report, and a caregiver report regarding child.
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Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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Change on Nightmare Locus of Control (NLOC)
Time Frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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The N-LOC is an 6 item self report.
This scale is collected as a child self report, and a caregiver report regarding child.
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Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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Change in reports on Sleep Journal
Time Frame: Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase (an average of 5 weeks), at Post treatment (for 1 week).
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6 question self report that patient assesses daily from home.
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Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase (an average of 5 weeks), at Post treatment (for 1 week).
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Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
Time Frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
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Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)
Time Frame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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The DBAS-16 is a 16-item self-report measure that evaluates the role of sleep related beliefs.
The score is a sum of the 16 items, ranging from 16 to 80. Higher scores represent more dysfunctional beliefs about sleep.
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Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
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Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time Frame: Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).
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The CES-DC is a 20-item self-report depression inventory.
A score of 15 or higher indicates significant levels of depression.
|
Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2020
Primary Completion (Actual)
June 16, 2023
Study Completion (Actual)
June 16, 2023
Study Registration Dates
First Submitted
October 3, 2022
First Submitted That Met QC Criteria
October 18, 2022
First Posted (Actual)
October 20, 2022
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 16, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB12343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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