Clinical trial NCT06033781: Cognitive-Behavioral Therapy for Children With Nightmares
Official title: Can a Brief Therapy Improve Pediatric Nightmares, Mental Health, and Suicidality?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nightmare
Suicidal Ideation
Children, Only
Keywords: CBT
Cognitive
Behavioral
Therapy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: University of Tulsa
First posted: 2023-09-13
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the efficacy of CBT-NC intervention to determine its impact on mental health and suicidality in children ages 6-17. The main aims are:

Aim 1: Examine CBT-NC efficacy for improving nightmare distress and frequency in youth with chronic nightmares by comparing the treatment and waitlist group.

Aim 2: Examine whether improvements in nightmares relate to fewer mental health problems for youth by determining by comparing the treatment and waitlist group.

Detailed description: Chronic nightmares in youth put them at risk for mental health problems including suicidal ideation and attempts. Left untreated, chronic childhood nightmares can persist, resulting in myriad mental health problems. An international consortium of nightmare experts urged the medical community to prevent mental health problems in youth through early detection and treatment of chronic nightmares. There are several well-established, brief, and cost-effective nightmare treatments for adults but research with youth is lagging. To date, several small case series have investigated nightmare treatments for youth and there is a need for clinical trials. The proposed study will evaluate the efficacy of Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC), a brief five-session manualized therapy designed to treat children ages 6-17. This randomized controlled trial with treatment and waitlist arms will assess the efficacy of the intervention and determine if the intervention has any impact on mental health problems and suicidality at follow-up.

This study will be the first randomized controlled trial to assess the efficacy of Cognitive behavioral therapy for nightmares in children (CBT-NC), compared to a waitlist group. Our goal is to determine whether CBT-NC can be an effective treatment strategy for reducing nightmares in youth, which are linked to suicidality.

First, this study will address the need for efficacious and cost-effective treatment for improving nightmare distress and frequency in youth with chronic nightmares. Second, this study will determine if improvements in nightmares reduce risk for youth mental health problems including suicidal ideation.

Eligibility criteria: Inclusion Criteria:

* Child must be between ages of 6-17 years 11 months.
* Child must report recurrent nightmares that meet Diagnostic and Statistical Manual of Mental Disorders 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.

Exclusion Criteria:

* Children with a 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: Changes in reports on Sleep Journal
timeFrame: Participants complete this daily from consent to baseline assessment (Week 0), during treatment, and before post-assessments, up to 20 weeks. They also complete a weekly version for 4 weeks following post-assessments (Weeks 10-14).
measure: Change in Nightmare Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid)
timeFrame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
measure: Change on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.
measure: Change on the Strengths and Difficulties Questionnaire (SDQ) - Caregiver Version
timeFrame: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
measure: Change on the Patient Health-Questionnaire-9 (PHQ-9)
timeFrame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Secondary outcomes:
measure: Change on the Child Adolescent Trauma Screen (CATS) - Child Version
timeFrame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
measure: Change on the Patient Health-Questionnaire-2 (PHQ-2)
timeFrame: Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.
measure: Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Version
timeFrame: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
measure: Change on Sleep Locus of Control (SLOC)
timeFrame: Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
measure: Change on Nightmare Locus of Control (NLOC)
timeFrame: Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
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:
affiliation: University of Tulsa
name: Lisa Cromer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Tara Buck, MD
role: PRINCIPAL_INVESTIGATOR
References: