Cognitive-Behavioral Therapy for Children With Nightmares

University of Oklahoma (OU)

Status: Enrolling

Conditions: Suicidal Ideation; Nightmare; Children, Only

Treatments: Behavioral: Cognitive Behavioral Therapy for Nightmares in Children

Study type: Interventional

Funder types: Other

Identifiers

NCT06033781

15401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Treatment Right-Away

Experimental group

Description:

Child will start the CBT-NC treatment right away.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Nightmares in Children

Waitlist Control

No Intervention group

Description:

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.