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Behavioral Intervention

Cognitive Behavioral Therapy for Childhood Nightmares

N/A

Recruiting

Led By Lisa Cromer, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child must be between ages of 6-17 years 11 months

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be assessed at baseline (week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.

Awards & highlights

Study Summary

This trial will assess if cognitive behavioral therapy with nightmare control can help reduce nightmares and mental health issues in children 6-17.

Who is the study for?

This trial is for children aged 6-17 who experience frequent nightmares and are not at immediate risk of self-harm. They must be stable on any psychotropic medications for 30 days, speak English at a minimum 6-year-old level, have a guardian to accompany them, and access to WIFI/data with a camera-enabled device.Check my eligibility

What is being tested?

The study tests if Cognitive-Behavioral Therapy specifically designed for Nightmares in Children (CBT-NC) can reduce the distress and frequency of nightmares. It also looks at whether this reduction improves overall mental health. Participants will either receive the therapy or be placed on a waitlist as part of the study's design.See study design

What are the potential side effects?

Since CBT-NC is a form of therapy involving no medication, side effects may include temporary increases in distress due to discussing nightmares or changes in sleep patterns during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 6 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be assessed at baseline (week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be assessed at baseline (week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed at baseline (week 0), at post-assessments, up to 20 weeks, and weekly following their post-assessment for 4 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Nightmare Disorder Diagnoses from Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid)

Change on the Columbia Suicide Severity Rating Scale (C-SSRS)

Change on the Patient Health-Questionnaire-9 (PHQ-9)

+2 more

Secondary outcome measures

Change on Nightmare Locus of Control (NLOC)

Change on Sleep Locus of Control (SLOC)

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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Right-AwayExperimental Treatment1 Intervention

Child will start the CBT-NC treatment right away.

Group II: Waitlist ControlActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,833 Total Patients Enrolled

University of TulsaOTHER

15 Previous Clinical Trials

10,735 Total Patients Enrolled

Lisa Cromer, PhDPrincipal InvestigatorUniversity of Tulsa

1 Previous Clinical Trials

13 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants meet to be accepted into this experiment?

"To be suitable for inclusion in this clinical trial, interested participants must present with suicidal ideation and possess an age between 6 - 17. Currently, the medical team is hoping to recruit around 90 people."

Answered by AI

Is the age restriction of this clinical trial in excess of sixty-years?

"This clinical trial is designed for those aged 6 to 17. It has separate trials for both minors and seniors, with 83 places available to each group."

Answered by AI

How many participants have been recruited to join this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial remains in the recruitment phase since it was first published on 8/7/2023 and last updated on 9/5/2023. The medical team behind this project needs 90 participants between 2 different sites."

Answered by AI

Are there still opportunities for patients to join this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research endeavour is actively recruiting individuals for participation. It was initially posted on August 7th 2023 and has been updated as recently as September 5th 2023. 90 patients are required across 2 main sites."

Answered by AI

What are the principal goals of this investigation?

"The primary objective of this clinical trial is to ascertain the effectiveness of a treatment on Nightmare Disorder Diagnoses utilizing the Structure Clinical Interview for Sleep Disorders in Children (SCISD-Kid). Secondary outcomes include changes measured by the Patient Health-Questionnaire-2 (PHQ-2), Child Adolescent Trauma Screen (CATS) - Caregiver Version, and Sleep Locus of Control (SLOC). Data collection will occur from consent to baseline assessment at Week 0, during treatment period, and prior to post assessments up until 20 weeks. Additionally, participants must complete weekly versions for 4 consecutive weeks following post assessments ranging from Weeks 10"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive-Behavioral Therapy for Children With Nightmares

2023. "Cognitive-Behavioral Therapy for Children With Nightmares". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06033781.