NightmareNCT06033781
Cognitive-Behavioral Therapy for Children With Nightmares
A study testing Cognitive Behavioral Therapy for Nightmares in Children in people with Nightmare and Suicidal Ideation, run by University of Oklahoma at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Nightmare, Suicidal Ideation, Children, Only
- What is being tested?
- Cognitive Behavioral Therapy for Nightmares in Children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2023to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University of Tulsa
Tulsa, Oklahoma, 74104
University of Oklahoma School of Community Medicine
Tulsa, Oklahoma, 74135
About this study
Official title: 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.
Read the 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.
- Conditions
- Nightmare, Suicidal Ideation, Children, Only
- Being tested
- Cognitive Behavioral Therapy for Nightmares in Children
- Keywords
- CBT, Cognitive, Behavioral, Therapy
- Medical subject headings
- Suicidal Ideation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Nightmares in ChildrenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Right-Away | Experimental | Child will start the CBT-NC treatment right away. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in reports on Sleep Journal
The sleep journal is a 3 question self report regarding nightmares.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Measured: 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)
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.
Measured: 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
The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question
Measured: Participants' caregivers will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Change on Sleep Locus of Control (SLOC)
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.
Measured: 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)
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.
Measured: 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)
The SCISD-Kid is a structured clinical interview that assesses for sleep disorders. The main module interest is the insomnia disorder module.
Measured: Participants will be assessed at baseline (Week 0) and at post-assessments, up to 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Aug 2023
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NightmareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tulsa
- Responsible party
- Sponsor
- Investigators
- Lisa Cromer, PhD, Principal investigator, University of TulsaTara Buck, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033781
- Sponsor's protocol ID
- 15401
- Status last verified
- Apr 2026
- First submitted
- 5 Sep 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Brief Therapy Improve Pediatric Nightmares, Mental Health, and Suicidality?
- ClinicalTrials.gov ID
- NCT06033781
- Acronym / sponsor ID
- 15401
- Conditions
- Nightmare, Suicidal Ideation, Children, Only
- Keywords
- CBT, Cognitive, Behavioral, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- University of Tulsa
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Right-Away | Experimental | Behavioral: Cognitive Behavioral Therapy for Nightmares in ChildrenChild will start the CBT-NC treatment right away. |
| 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Nightmares in ChildrenThe 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. | Behavioural | Treatment Right-Away |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Cromer, PhD principal investigator
University of Tulsa
Tara Buck, MD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Nightmares in Children in people with Nightmare and Suicidal Ideation, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.