- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02184026
Exposure, Relaxation, & Rescripting Therapy-Child (ERRT-C)
June 17, 2016 updated by: Cameo Borntrager, University of Montana
The study implements a trauma-related nightmare treatment for children aged 8 to 13 years.
Relevant outcome progress and outcome measures on symptoms, nightmare distress and duration, academic indicators, and sleep quality will be examined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 one of the first randomized clinical trials with children, adapting an efficacious adult therapy to a 5-session nightmare treatment for 8-13 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 health care option to Montanans, 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.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Montana
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Missoula, Montana, United States, 59812
- University of Montana
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children age 8-13 with PTSD Criterion A event as defined by the DSM-IV 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exposure, Relaxation, & Rescripting Therapy-Child
Exposure, Relaxation, & Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 follow-ups at 3 months & 6 months post treatment.
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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.
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Participants will be assessed immediately after treatment which occurs on average for 5 weeks, and then will be assessed for follow-ups at 3 months & 6 months post treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index for the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) (UPID)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The UPID screens for trauma exposure and posttraumatic symptoms among youth 7 to 18 years old.
It queries types of trauma exposures, assesses for DSM-IV criteria of traumatic exposure and the past-month frequency of PTSD symptoms and two associated features of PTSD in childhood.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Revised Child Anxiety and Depression Scale (RCADS)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The RCADS is a 47-item scale that corresponds to the DSM-IV anxiety disorders and it incorporates a sub scale for major depression.
There is a six-factor structure with the following sub scales: Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Panic Disorder, and Major Depressive Disorder.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Nightmare Distress Questionnaire - Modified (NDQ)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The NDQ is a 13-item self-report measure of nightmare related distress.
Higher scores are significantly related to interest in therapy for nightmares.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The PSQI is a 19-item self-report measure of sleep quality and disturbance.
It queries sleep quality and disturbances over the last month.
Seven component scores are generated from this measure including: subjective sleep quality, latency, duration, habitual sleep efficiency, sleep problems, use of sleep medications, and daytime dysfunction.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Strength and Difficulties Questionnaire - Child Version (SDQ)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The SDQ is a self-report instrument designed for completion by 11-16 year-olds.
Specifically, children respond to 25 attributes (emotional, conduct, hyperactivity, peer relationships, and prosocial behaviors).
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The CSHQ is a 33-item parent-report measure of sleep behavior that can be used by parents of school-aged children.
A total score is derived from items from 8 sub scales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep-Disordered Breathing, and Daytime Sleepiness.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Strengths and Difficulties Questionnaire - Parent Version (SDQ)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The SDQ has two parent versions designed for 4-10 year-olds and 11-16 year-olds.
Specifically, parents respond to 25 attributes (emotional, conduct, hyperactivity, peer relationships, and prosocial behavior).
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The Parenting Stress Scale (PSS)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The PSS is an 18-item measure that assesses stress related to parenting (e.g., "I am happy in my role as a parent," "Having child(ren) has been a financial burden").
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Pittsburgh Sleep Quality Index - Parent self-report (PSQI)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Similar to the child version, the adult form of the PSQI is a 19-item self-report measure of sleep quality and disturbance.
It queries sleep quality and disturbances over the last month.
It will serve as an index of secondary gain from treatment by way of parent's improved sleep quality and quantity.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The McMaster Family Assessment Device (FAD)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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The FAD is a 53-item measure that identifies seven dimensions of family functioning: Problem Solving, Communication, Roles, Affective Responses, Affective Involvement, Behavior Control, and General Functioning.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Academic Grade Point Average (GPA)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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GPA will be collected as a measure of academic performance.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trail Making Test
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A neuropsychological test of visual attention and task switching.
It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy.
It provides information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Wechsler Intelligence Scale for Children (WISC-IV), Letter-Number Sequencing subtest
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A measure of attention, short-term auditory memory, and processing speed.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Wechsler Intelligence Scale for Children (WISC-IV), Digit Span subtest
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A measure of auditory short-term memory, attention, and concentration.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Child Attention Network Task
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A task designed to test attention shifting, alerting, orienting, and executive control networks.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A Developmental NEuroPSYchological Assessment (NEPSY-II), Animal Sorting subtest
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A measure of attention and executive functions.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A Developmental NEuroPSYchological Assessment (NEPSY-II), Auditory Attention & Response Set subtest
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A measure of attention and executive functions.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A Developmental NEuroPSYchological Assessment (NEPSY-II), Clocks subtest
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A measure of attention and executive functions.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Aimsweb Reading Curriculum-Based Measurement (R-CBM)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A measure designed to be a short (one minute) fluency measure used to regularly monitor the development of early literacy and early reading skills.
Results can be used to evaluate individual student development.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Aimsweb MAZE Reading Curriculum-Based Measurement (MAZE-CBM)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A supplemental measure to provide a more complete picture of a child's reading skill.
Maze is a multiple-choice task that children complete while reading silently.
The first sentence of a 150-400 word passage is left intact.
Thereafter, every 7th word is replaced with three words inside parenthesis.
The child must choose the correct word.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4)
Time Frame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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A standardized assessment that evaluates receptive language, as an index of cognitive ability.
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1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cameo Borntrager, Ph.D., University of Montana
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
July 23, 2013
First Submitted That Met QC Criteria
July 2, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
June 20, 2016
Last Update Submitted That Met QC Criteria
June 17, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MRA-778
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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