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Randomized Controlled Trial for a Cognitive-Behavioral Therapy for Children With Nightmares

Primary Purpose

Nightmare, Suicidal Ideation, Children, Only

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Nightmares in Children
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nightmare focused on measuring CBT, Cognitive, Behavioral, Therapy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University of TulsaRecruiting
  • University of Oklahoma School of Community MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Right-Away

Waitlist Control

Arm Description

Child will start the CBT-NC treatment right away.

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.

Outcomes

Primary Outcome Measures

Changes in reports on Sleep Journal
The sleep journal is a 3 question self report regarding nightmares.
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.
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.
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).
Change on the Patient Health-Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-question Likert scale questionnaire to assess for depression.

Secondary Outcome Measures

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
Change on the Patient Health-Questionnaire-2 (PHQ-2)
The PHQ-9 is a 2-question Likert scale questionnaire to screen for depression.
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
Change on Sleep Locus of Control (SLOC)
The SLOC is a 6 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.
Change on Nightmare Locus of Control (NLOC)
The NLOC is a 6 item self report measure regarding nightmare behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.

Full Information

First Posted
September 5, 2023
Last Updated
September 5, 2023
Sponsor
University of Oklahoma
Collaborators
University of Tulsa
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1. Study Identification

Unique Protocol Identification Number
NCT06033781
Brief Title
Randomized Controlled Trial for a Cognitive-Behavioral Therapy for Children With Nightmares
Official Title
Can a Brief Therapy Improve Pediatric Nightmares, Mental Health, and Suicidality?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
University of Tulsa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nightmare, Suicidal Ideation, Children, Only
Keywords
CBT, Cognitive, Behavioral, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Right-Away
Arm Type
Experimental
Arm Description
Child will start the CBT-NC treatment right away.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Nightmares in Children
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in reports on Sleep Journal
Description
The sleep journal is a 3 question self report regarding nightmares.
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).
Title
Change in Nightmare Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid)
Description
The SCISD-Kid is a structured clinical interview that assesses for sleep disorders. The main module interest is the nightmare disorder module.
Time Frame
Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Title
Change on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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.
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.
Title
Change on the Strengths and Difficulties Questionnaire (SDQ) - Caregiver Version
Description
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).
Time Frame
Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Title
Change on the Patient Health-Questionnaire-9 (PHQ-9)
Description
The PHQ-9 is a 9-question Likert scale questionnaire to assess for depression.
Time Frame
Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Secondary Outcome Measure Information:
Title
Change on the Child Adolescent Trauma Screen (CATS) - Child Version
Description
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Time Frame
Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Title
Change on the Patient Health-Questionnaire-2 (PHQ-2)
Description
The PHQ-9 is a 2-question Likert scale questionnaire to screen for depression.
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.
Title
Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Version
Description
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Time Frame
Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Title
Change on Sleep Locus of Control (SLOC)
Description
The SLOC is a 6 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.
Time Frame
Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.
Title
Change on Nightmare Locus of Control (NLOC)
Description
The NLOC is a 6 item self report measure regarding nightmare behavior and events. This scale is collected as a child self report, and a caregiver report regarding child.
Time Frame
Participants and caregivers will be assessed at Baseline (Week 0), post-assessments, and weekly during therapy, up to 20 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Prince, BA
Phone
918-634-3242
Email
lauren-prince@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Cromer, PhD
Organizational Affiliation
University of Tulsa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tara Buck, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Cromer, PhD
Phone
918-938-1441
Email
lisa-cromer@utulsa.edu
First Name & Middle Initial & Last Name & Degree
Lisa Cromer, PhD
Facility Name
University of Oklahoma School of Community Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Matukewicz, MHR
Phone
918-660-3118
Email
michelle-mautekwicz@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Tara Buck, MD
Phone
918-660-3507
Email
tara-buck@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Tara Buck, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Controlled Trial for a Cognitive-Behavioral Therapy for Children With Nightmares

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