Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA) (COMAA)
Primary Purpose
Nightmare
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Nightmare focused on measuring Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive, Behavioral, Therapy, Suicidality
Eligibility Criteria
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.
Sites / Locations
- University of Tulsa
- University of Oklahoma School of Community Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Right-Away
Waitlist Control
Arm Description
Cognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
Waitlist control group will complete pre and post assessments at beginning and end of wait period.
Outcomes
Primary Outcome Measures
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)
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.
Change on Sleep Locus of Control (SLOC)
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.
Change on Nightmare Locus of Control (NLOC)
The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Change in reports on Sleep Journal
6 question self report that patient assesses daily from home.
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)
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.
Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
The CES-DC is a 20-item self-report depression inventory. A score of 15 or higher indicates significant levels of depression.
Secondary Outcome Measures
Full Information
NCT ID
NCT05588739
First Posted
October 3, 2022
Last Updated
June 16, 2023
Sponsor
University of Oklahoma
Collaborators
University of Tulsa
1. Study Identification
Unique Protocol Identification Number
NCT05588739
Brief Title
Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)
Acronym
COMAA
Official Title
Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
June 16, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
University of Tulsa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nightmare
Keywords
Nightmares, Children, Trauma, CBT, Exposure, Relaxation, Rescripting, Cognitive, Behavioral, Therapy, Suicidality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Blinded randomization into 2 groups: Treatment & Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after a 5 week wait.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Right-Away
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Waitlist control group will complete pre and post assessments at beginning and end of wait period.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
Primary Outcome Measure Information:
Title
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
Description
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Time Frame
Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Title
Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)
Description
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.
Time Frame
Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Title
Change on Sleep Locus of Control (SLOC)
Description
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.
Time Frame
Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Title
Change on Nightmare Locus of Control (NLOC)
Description
The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.
Time Frame
Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Title
Change in reports on Sleep Journal
Description
6 question self report that patient assesses daily from home.
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).
Title
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
Description
The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Time Frame
Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Title
Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)
Description
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.
Time Frame
Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Title
Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Description
The CES-DC is a 20-item self-report depression inventory. A score of 15 or higher indicates significant levels of depression.
Time Frame
Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
University of Oklahoma School of Community Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)
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