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Completed

NCT Number: NCT04047277

Cognitive Behavioral Therapy for Nightmares in Children

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.

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Key information

Conditions

Nightmare Behavior Wounds and Injuries

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma School of Community Medicine, Tulsa, Oklahoma, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: approximately 3 years.

    Assesses adverse experiences from infancy through early childhood

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

    Time frame: 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 outcomes

  1. Change on the Parental Stress Scale

    Time frame: 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

    Time frame: approximately 3 years.

    Assesses adverse experiences from infancy through early childhood

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • University of Tulsa

Registry information

Official study title

Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children

Acronym: CBT-NC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2019
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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