Clinical trial NCT05588739: Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk (COMAA)
Official title: Evaluating the Feasibility of a Cognitive-Behavioral Therapy for Children With Nightmares as a Mediator of Suicide Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmare
Keywords: Nightmares
Children
Trauma
CBT
Exposure
Relaxation
Rescripting
Cognitive
Behavioral
Therapy
Suicidality
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: University of Tulsa
First posted: 2022-10-20
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change on the Child Adolescent Trauma Screen (CATS) - Child Version
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
measure: Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
measure: Change on Sleep Locus of Control (SLOC)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
measure: Change on Nightmare Locus of Control (NLOC)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
measure: Change in reports on Sleep Journal
timeFrame: 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).
measure: Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
measure: Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, up to 15 weeks.
measure: Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
timeFrame: Participants will be assessed at Baseline (Week 0) and after post-condition (Week 6).
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Tulsa
state: Oklahoma
city: Tulsa
country: United States
facility: University of Oklahoma School of Community Medicine
state: Oklahoma
Study officials:
References: