Cognitive-Behavioral Therapy for Children With Nightmares

NCT06033781 | Completed

• 1 other identifier: 15401
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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.

Conditions

Nightmare; Suicidal Ideation; Children, Only

Keywords

CBT; Cognitive; Behavioral; Therapy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

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

  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)

  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

  Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.

• Change on Sleep Locus of Control (SLOC)

  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)

  Participants and caregivers will be assessed at baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.

Study Arms (2)

Treatment Right-Away

EXPERIMENTAL

Child will start the CBT-NC treatment right away.

Behavioral: Cognitive Behavioral Therapy for Nightmares in Children

Waitlist Control

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy for Nightmares in Children BEHAVIORAL

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.

Treatment Right-Away

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead
• University of Tulsa: collaborator

Study Sites (2)

University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Behavior

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa Cromer, PhD

  University of Tulsa

  PRINCIPAL INVESTIGATOR

• Tara Buck, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: August 7, 2023
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)