Cognitive-Behavioral Therapy for Children With Nightmares

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can a Brief Therapy Improve Pediatric Nightmares, Mental Health, and Suicidality?

Conditions
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Nightmare, Suicidal Ideation, Children, Only

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Nightmares in Children


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Right-Away<br>Child will start the CBT-NC treatment right away. | Behavioral: Cognitive Behavioral Therapy for Nightmares in Children<br>* The Cognitive Behavioral Therapy for Nightmares in Children (CBT-NC) is a brief, five-session manualized therapy designed to treat children ages 6-17. The manualized CBT protocol is five session that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.<br>|
| No Intervention: Waitlist Control<br>Waitlist control group will complete the assessments at the same time as the treatment group, without receiving any treatment. They will be offered treatment after finishing the waitlist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in reports on Sleep Journal | The sleep journal is a 3 question self report regarding nightmares. | 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). | 
| Change in Nightmare Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid) | The SCISD-Kid is a structured clinical interview that assesses for sleep disorders. The main module interest is the nightmare disorder module. | Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks. | 
| Change on the Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a yes/no questionnaire to assess for suicidal ideations and behaviors. For this study, we will be looking at the 5 suicidal ideation questions. | Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks. | 
| Change on the Strengths and Difficulties Questionnaire (SDQ) - Caregiver Version | The SDQ is a 25-item brief behavioral screening questionnaire for detecting mental health problems in general populations people aged 2-17. It assesses three scales for internalizing problems (10 items), externalizing problems (10 items), and prosocial behavior (5 items). The internalizing and externalizing scales have scores ranging from 0 to 20 with higher scores indicating more difficulties. The prosocial behavior scale ranges from 0 to 10 with higher scores indicating more prosocial behaviors. | Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks. | 
| Change on the Patient Health-Questionnaire-9 (PHQ-9) | The PHQ-9 is a 9-question Likert scale questionnaire to assess for depression. The items are scored on a scale of 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. | Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) and at post-assessments, up to 20 weeks. | 
| Change on the Patient Health-Questionnaire-2 (PHQ-2) | The PHQ-9 is a 2-question Likert scale questionnaire to screen for depression. Scores range from 0-6. A score of 3 or greater indicates major depressive disorder may exist. | Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks. | 
| Change on the Child Adolescent Trauma Screen (CATS) - Caregiver 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' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks. | 
| Change on Sleep Locus of Control (SLOC) | The SLOC is a 5 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. The items are answered with a 1-5 Likert scale with total scores ranging from 5 to 25. Higher scores indicate higher locus of control. | Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks. | 
| Change on Nightmare Locus of Control (NLOC) | The NLOC is a 5 item self report measure regarding nightmare behavior and events. This scale is collected as a child self report, and a caregiver report regarding child. The items are answered with a 1-5 Likert scale with total scores ranging from 5 to 25. Higher scores indicate higher locus of control. | Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, Cognitive, Behavioral, Therapy