Cognitive Behavioral Therapy for Nightmares in Children

Nightmare Clinical Trial

— CBT-NC  

Official title:

Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047277
• Other study ID #: IRB9653
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2022
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Nightmare

Intervention

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.

Locations

Country	Name	City	State
United States	University of Oklahoma School of Community Medicine	Tulsa	Oklahoma
United States	University of Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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).
Primary	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.
Primary	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.
Primary	Adverse Childhood Experiences for CHILD - Caregiver Report regarding child	Assesses adverse experiences from infancy through early childhood	approximately 3 years.
Primary	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	Change on the Parental Stress Scale	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.	Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Secondary	Adverse Childhood Experiences for SELF - Caregiver Report regarding self	Assesses adverse experiences from infancy through early childhood	approximately 3 years.