CompletedNot Applicable

Cognitive-Behavioral Therapy for Children With Nightmares

United States57 participantsStarted 2023-08-07

Plain-language 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.

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

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.

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.

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.

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.

Trial details

NCT IDNCT06033781

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-15

View on ClinicalTrials.gov More Nightmare trials

Plain-language summary

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in reports on Sleep Journal

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.

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.

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.

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.