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

University of Oklahoma2 sites in 1 country58 target enrollmentStarted: September 30, 2020Last updated: June 22, 2023

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: University of Oklahoma
Enrollment: 58
Locations: 2
Primary Endpoint: Change on the Child Adolescent Trauma Screen (CATS) - Child Version

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Eligibility Criteria

Ages: 6 Years to 17 Years (Child)
Sex: All
Accepts Healthy Volunteers: No

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.

Arms & Interventions

Treatment Right-Away

Experimental

Cognitive Behavioral Therapy using exposure, relaxation, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.

Intervention: Cognitive Behavioral Therapy (Behavioral)

Waitlist Control

No Intervention

Waitlist control group will complete pre and post assessments at beginning and end of wait period.