Clinical trial NCT04047277: Cognitive Behavioral Therapy for Nightmares in Children
Official title: Clinical Outcomes of Cognitive Behavioral Therapy for Nightmares in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmare
Keywords: Nightmares
Children
Trauma
CBT
Exposure
Relaxation
Rescripting
Cognitive
Behavioral
Therapy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: University of Tulsa
First posted: 2019-08-06
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change on the Child Adolescent Trauma Screen (CATS) - Child Version
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Trauma Related Nightmare Survey (TRNS-C) - Child Version
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Nightmare Distress Questionnaire (NDQ)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Nightmare Locus of Control (NLOC)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Pittsburgh Sleep Quality Index - Modified (PSQI) - Child Version
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Children's Report of Sleep Patterns (CRSP)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Sleep Locus of Control (SLOC)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Epworth Sleepiness Scale (ESS)
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change in reports on Sleep Journal
timeFrame: 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).
measure: Change on the Child Adolescent Trauma Screen (CATS) - Caregiver Report regarding child
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Change on the Children's Sleep Habits - Caregiver Report regarding child
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Adverse Childhood Experiences for CHILD - Caregiver Report regarding child
timeFrame: approximately 3 years.
measure: Change on the Sleep Disturbances Scale for Children - Caregiver Report regarding child
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
Secondary outcomes:
measure: Change on the Parental Stress Scale
timeFrame: Participants will be assessed at Baseline (Week 0) through study completion, an average of 6 months.
measure: Adverse Childhood Experiences for SELF - Caregiver Report regarding self
timeFrame: approximately 3 years.
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Tulsa
state: Oklahoma
city: Tulsa
country: United States
facility: University of Oklahoma School of Community Medicine
state: Oklahoma
Study officials:
affiliation: University of Tulsa
name: Lisa M Cromer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma School of Community Medicine
name: Tara R Buck, MD
role: PRINCIPAL_INVESTIGATOR
References: