CBT-NC: Cognitive Behavioral Therapy for Nightmares in Children

Sponsor
University of Oklahoma (Other)
Overall Status
Unknown status
CT.gov ID
NCT04047277
Collaborator
University of Tulsa (Other)
90
2
2
36
45
1.3

Study Details

Study Description

Brief Summary

Up to 50% of children experience nightmares annually. Nightmares interfere with sleep quality and quantity resulting in sleep deficiency, and are associated with negative mental health consequences. Previous research has shown efficacy of manualized CBT treatment for reducing trauma related nightmares in adults, and preliminary evidence has shown efficacy in children. This study is the first randomized clinical trial to evaluate the effectiveness of the treatment for idiopathic, as well as trauma related nightmares in children. The treatment in a manualized CBT protocol (5 sessions) that teaches sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Blinded randomization into 2 groups: Treatment & Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after 6 week wait.Blinded randomization into 2 groups: Treatment & Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after 6 week wait.
Masking:
Single (Outcomes Assessor)
Masking Description:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children
Actual Study Start Date :
Mar 22, 2019
Anticipated Primary Completion Date :
Mar 21, 2022
Anticipated Study Completion Date :
Mar 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Right-Away

Cognitive Behavioral Therapy using exposure, relaxztion, and rescripting - Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.

Behavioral: Cognitive Behavioral Therapy
The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.

No Intervention: Waitlist Control

Waitlist control group will complete pre and post assessments at beginning and end of wait period.

Outcome Measures

Primary Outcome Measures

  1. Change on the Child Adolescent Trauma Screen (CATS) - Child Version [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The CATS screens for child trauma history and PTSD symptoms in youth ages 7-17; 15 YES/NO questions; 1 open-ended question

  2. Change on the Trauma Related Nightmare Survey (TRNS-C) - Child Version [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The TRNS-C is a 14 item self report measure that assesses current sleep quality, frequency, severity, and duration of nightmares, as well as cognitions, emotions, and behaviors related to nightmares in children.

  3. Change on the Nightmare Distress Questionnaire (NDQ) [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The NDQ is a 13 item self report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.

  4. Change on the Nightmare Locus of Control (NLOC) [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The N-LOC is an 6 item self report. This scale is collected as a child self report, and a caregiver report regarding child.

  5. Change on the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The PSQI-M is a 10 item (with 2 items containing 23 sub items) self report measure of sleep quality and disturbance. It queries sleep quality and disturbances over the last month.

  6. Change on the Children's Report of Sleep Patterns (CRSP) [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The CRSP is a 62 item self report measure of children's sleep patterns, sleep hygiene, and sleep disturbances for children eight to 12 years of age

  7. Change on the Sleep Locus of Control (SLOC) [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The SLOC is an 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.

  8. Change on the Epworth Sleepiness Scale (ESS) [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The ESS is an 8 item self report. The test is a list of eight situations in which one rates his/her tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the test is finished, response values are added up. The total score is based on a scale of 0 to 24. The scale estimates whether one is experiencing excessive sleepiness that possibly requires medical attention.

  9. Change in reports on Sleep Journal [Participants complete this assessment at Pre-treatment (for 1 week), daily during the treatment phase, at Post treatment (for 1 week), at 3 month follow-up (for 1 week), and at 6 month follow-up (for 1 week).]

    6 question self report that patient assesses daily from home.

  10. Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    The CATS screens for child trauma history and PTSD symptoms (information obtained from the caregiver, about the child).

  11. Change on the Children's Sleep Habits - Caregiver Report regarding child [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    To examine sleep habits and possible difficulties with sleep in preschool and school-aged children

  12. Adverse Childhood Experiences for CHILD - Caregiver Report regarding child [approximately 3 years.]

    Assesses adverse experiences from infancy through early childhood

  13. Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    SDSC is a 26-item inventory rated on a 5 point Likert-type scale. The instrument's purpose is to categorize sleep disorders in children

Secondary Outcome Measures

  1. Change on the Parental Stress Scale [Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.]

    18 item self report scale used for the assessment of parental stress for both mothers and fathers and for parents of children with and without clinical problems. • 5 - Point scale; strongly disagree, disagree, undecided, agree, strongly agree. A low score signifies a low level of stress, and a high score to signifies a high level of stress.

  2. Adverse Childhood Experiences for SELF - Caregiver Report regarding self [approximately 3 years.]

    Assesses adverse experiences from infancy through early childhood

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children must have a history of nightmares occurring approximately once or more per week over a minimum of one month.

  • Children must have verbal comprehension of at least age 5 (determined by PPVT), and be fluent in English.

  • If taking psychotropic medications, must be stable for one month.

  • Children must have a parent or legal guardian who is able to participate in treatment assignments and be able to read and speak English.

Exclusion Criteria:
  • Under age 5 or over age 17.

  • No nightmares (or less than averaging one per week)

  • Apparent psychosis

  • Pervasive developmental disorder or mental retardation

  • Not able to read and speak English.

  • Sleep apnea

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Tulsa Tulsa Oklahoma United States 74104
2 University of Oklahoma School of Community Medicine Tulsa Oklahoma United States 74135

Sponsors and Collaborators

  • University of Oklahoma
  • University of Tulsa

Investigators

  • Principal Investigator: Lisa M Cromer, PhD, University of Tulsa
  • Principal Investigator: Tara R Buck, MD, University of Oklahoma School of Community Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT04047277
Other Study ID Numbers:
  • IRB9653
First Posted:
Aug 6, 2019
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Oklahoma

Study Results

No Results Posted as of Mar 10, 2020