Cognitive-Behavioral Therapy for Children With Nightmares

April 20, 2026 updated by: University of Oklahoma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • University of Oklahoma School of Community Medicine
      • Tulsa, Oklahoma, United States, 74104
        • University of Tulsa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Right-Away
Child will start the CBT-NC treatment right away.
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.
No Intervention: Waitlist Control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in reports on Sleep Journal
Time Frame: 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).
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)
Time Frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
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)
Time Frame: Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.
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
Time Frame: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
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)
Time Frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
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
Time Frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
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 Child Adolescent Trauma Screen (CATS) - Caregiver Version
Time Frame: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
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 the Patient Health-Questionnaire-2 (PHQ-2)
Time Frame: Participants will be assessed at baseline (Week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.
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 Sleep Locus of Control (SLOC)
Time Frame: Participants and caregivers will be assessed at baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
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)
Time Frame: Participants and caregivers will be assessed at baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
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.
Change in Insomnia Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid)
Time Frame: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
The SCISD-Kid is a structured clinical interview that assesses for sleep disorders. The main module interest is the insomnia disorder module.
Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

University of Tulsa

Investigators

  • Principal Investigator: Lisa Cromer, PhD, University of Tulsa
  • Principal Investigator: Tara Buck, MD, University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2023

Primary Completion (Actual)

April 15, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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