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

NCT05588739 | Completed

• 1 other identifier: IRB12343
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Nightmare

Keywords

Nightmares; Children; Trauma; CBT; Exposure; Relaxation; Rescripting; Cognitive; Behavioral; Therapy; Suicidality

Outcome Measures

Primary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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).

• 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.

• 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.

• 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).

Study Arms (2)

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.

Behavioral: Cognitive Behavioral Therapy

Waitlist Control

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Treatment Right-Away

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• University of Tulsa: collaborator

Study Sites (2)

University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, 74135, United States

Location

Related Publications (1)

• Cromer LD, Bell SB, Prince LE, Hollman N, El Sabbagh E, Buck TR. Efficacy of a telehealth cognitive behavioral therapy for improving sleep and nightmares in children aged 6-17. Front Sleep. 2024 Jul 11;3:1401023. doi: 10.3389/frsle.2024.1401023. eCollection 2024.

  PMID: 41424486 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Behavior; Suicidal Ideation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded randomization into 2 groups: Treatment \& Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after a 5 week wait.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 20, 2022
• Study Start: September 30, 2020
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)