Cognitive Behavioral Therapy for Nightmares in Children

NCT04047277 | Completed

• 1 other identifier: IRB9653
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Nightmare

Keywords

Nightmares; Children; Trauma; CBT; Exposure; Relaxation; Rescripting; Cognitive; Behavioral; Therapy

Outcome Measures

Primary Outcomes (13)

• 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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Trauma Related Nightmare Survey (TRNS-C) - Child Version

  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.

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Nightmare Distress Questionnaire (NDQ)

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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Nightmare Locus of Control (NLOC)

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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version

  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.

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Children's Report of Sleep Patterns (CRSP)

  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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Sleep Locus of Control (SLOC)

  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.

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Epworth Sleepiness Scale (ESS)

  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.

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change in reports on Sleep Journal

  6 question self report that patient assesses daily from home.

  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).

• Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child

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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Change on the Children's Sleep Habits - Caregiver Report regarding child

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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Adverse Childhood Experiences for CHILD - Caregiver Report regarding child

  Assesses adverse experiences from infancy through early childhood

  approximately 3 years.

• Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child

  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

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

Secondary Outcomes (2)

• Change on the Parental Stress Scale

  Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.

• Adverse Childhood Experiences for SELF - Caregiver Report regarding self

  approximately 3 years.

Study Arms (2)

Treatment Right-Away

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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

Treatment Right-Away

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• University of Tulsa: collaborator

Study Sites (2)

University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

University of Oklahoma School of Community Medicine

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Behavior

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa M Cromer, PhD

  University of Tulsa

  PRINCIPAL INVESTIGATOR

• Tara R Buck, MD

  University of Oklahoma School of Community Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded randomization into 2 groups: Treatment \& Waitlist Control. Treatment group receives treatment right away. Waitlist group receives treatment after 6 week wait.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: August 6, 2019
• Study Start: March 22, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)