Overview

This trial is active, not recruiting.

Condition nightmares associated with trauma and stress
Treatment exposure, relaxation, & rescripting therapy-child
Sponsor University of Tulsa
Start date October 2012
End date November 2016
Trial size 24 participants
Trial identifier NCT01776229, TU 11-63RI

Summary

Untreated trauma-related nightmares and sleep-related disorders are associated with chronic health problems, burdening both the suffering individual and the health-care system. The study implements an innovative, cost-efficient, nightmare treatment for trauma-exposed children. It is the first randomized clinical trial with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 5-17 year-olds. Trauma nightmares are a mechanism in development and maintenance of secondary post-trauma psychopathology, medical problems and family dysfunction. Therefore, this treatment may prevent long-term secondary health and behavioral problems. It provides a viable healthcare option to Oklahomans, lessening long-term financial medical and behavioral health expenses. Scientific models currently view PTSD treatment as primary, often leaving nightmares untreated. That approach does not address the pernicious impact of trauma-nightmares in individuals with sub-threshold PTSD or whose nightmares are a primary condition. The theoretical innovation of this therapy can advance the field's understanding of the development of trauma sequelae.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Exposure, Relaxation, & Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
exposure, relaxation, & rescripting therapy-child
Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, psycho-education, Progressive Muscle Relaxation, diaphragmatic breathing,child-friendly exposure to the trauma-nightmare, and rescription.
(No Intervention)
All potential participants will be evaluated and some will be randomly placed in the control group, following the five-week treatment phase, participants in the control group will be re-evaluated and offered the treatment

Primary Outcomes

Measure
Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration.
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.

Secondary Outcomes

Measure
University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index for the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) (UPID)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Revised Child Anxiety and Depression Scale (RCADS)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Nightmare Distress Questionnaire - Modified (NDQ)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Pittsburgh Sleep Quality Index (PSQI)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Strengths and Difficulties Questionnaire - Child Version (SDQ)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Children's Sleep Habits Questionnaire (CSHQ)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Strengths and Difficulties Questionnaire - Parent Version (SDQ)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
The Parenting Stress Scale (PSS)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Pittsburgh Sleep Quality Index - Parent self-report (PSQI)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
The McMaster Family Assessment Device (FAD)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Behavior Rating Inventory of Executive Function - Parent Form (BRIEF)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Child Behavior Checklist - Teacher Form (CBCL-TR)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks.
Behavior Rating Inventory of Executive Function - Teacher Form (BRIEF)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks.
Child Attention Network Task (Child ANT)
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Trail Making Test
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Animal Sorting
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Auditory Attention and Response Set
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Clocks
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Actiwatch-2 Wrist Monitor
time frame: The wrist actigraph will be worn between session for a specified amount of time. The actigraph will be worn continously during the loan period except for swimming, other continous water sports, and bathing.
Letter-Number Sequencing
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
Digit span
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
R-CBM
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.
MAZE
time frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for followups at 3 months and 6 months post treatment.

Eligibility Criteria

Male or female participants from 5 years up to 17 years old.

Inclusion Criteria: - children age 5-17 with traumatic or potentially traumatic/adverse experiences and nightmares occurring at least once per week over a minimum of one month - have a parent or legal guardian who is able to participate in treatment assignments at home and be able to read and speak English Exclusion Criteria: - adult, no traumatic experience, no nightmares, apparent psychosis, pervasive developmental disorder, or mental retardation, not able to read and speak English - in order to ensure the verbal comprehension of the child, the PPVT will be used to help evaluate if a child is suitable for treatment, as an index to ensure they can verbally comprehend the cognitive component of treatment

Additional Information

Official title Exposure, Relaxation, & Rescripting Therapy-Child
Principal investigator Lisa Cromer, Phd
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Tulsa.