Cognitive-Behavioral Therapy for Children With Nightmares

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033781
• Other study ID #: 15401
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: University of Oklahoma
• Contact: Lauren Prince, BA
• Phone: 918-634-3242
• Email: lauren-prince[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children, Only
• Nightmare
• Suicidal Ideation

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Nightmares in Children
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.

Locations

Country	Name	City	State
United States	University of Oklahoma School of Community Medicine	Tulsa	Oklahoma
United States	University of Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.