Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)

Not Applicable

Completed

• Conditions: Nightmare
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT05588739
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-30
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-20
• Status Verified: 2023-06
• Primary Completion: 2023-06-16
• Study Completion: 2023-06-16
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Right-Away	Cognitive Behavioral Therapy	Cognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.

Primary Outcome Measures

Name	Time	Method
Change on the Child Adolescent Trauma Screen (CATS) - Child Version	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.	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 Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.	The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).
Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)	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.
Change on Sleep Locus of Control (SLOC)	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.	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 in reports on Sleep Journal	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).	6 question self report that patient assesses daily from home.
Change on Nightmare Locus of Control (NLOC)	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.	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 on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.	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)	Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).	The CES-DC is a 20-item self-report depression inventory. A score of 15 or higher indicates significant levels of depression.

Trial Locations

Locations (2)

University of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States

University of Oklahoma School of Community Medicine; 🇺🇸 Tulsa, Oklahoma, United States