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

Nightmare Clinical Trial

— COMAA  

Official title:

Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588739
• Other study ID #: IRB12343
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: June 16, 2023

Study information

• Verified date: June 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nightmare
• Suicide

Intervention

Behavioral:
• Cognitive Behavioral Therapy
The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

Locations

Country	Name	City	State
United States	University of Oklahoma School of Community Medicine	Tulsa	Oklahoma
United States	University of Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Primary	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.	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Primary	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.	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Primary	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.	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Primary	Change in reports on Sleep Journal	6 question self report that patient assesses daily from home.	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).
Primary	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).	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Primary	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.	Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
Primary	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.	Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).