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Completed

NCT Number: NCT05588739

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

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.

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Key information

Conditions

Nightmare Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide Wounds and Injuries

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma School of Community Medicine, Tulsa, Oklahoma, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change on the Child Adolescent Trauma Screen (CATS) - Child Version

    Time frame: 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

  2. Change on the Trauma Related Nightmare Survey - Child Version (TRNS-C)

    Time frame: 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.

  3. Change on Sleep Locus of Control (SLOC)

    Time frame: 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.

  4. Change on Nightmare Locus of Control (NLOC)

    Time frame: 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.

  5. Change in reports on Sleep Journal

    Time frame: 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.

  6. Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child

    Time frame: 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).

  7. Change on Center for Epidemiologic Studies Beliefs and Attitudes About Sleep Scale (DBAS-16)

    Time frame: 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.

  8. Change on Center for Epidemiologic Studies Depression Scale for Children (CES-DC)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • University of Tulsa

Registry information

Official study title

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

Acronym: COMAA

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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