Exposure, Relaxation, & Rescripting Therapy-Child (ERRT-C)

This study is currently recruiting participants.
Verified February 2014 by University of Tulsa
Sponsor:
Information provided by (Responsible Party):
Lisa Cromer, University of Tulsa
ClinicalTrials.gov Identifier:
NCT01776229
First received: July 24, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 5-12 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.


Condition Intervention
Nightmares Associated With Chronic Post-traumatic Stress Disorder
Sleep Disorders
Behavioral: Exposure, Relaxation, & Rescripting Therapy-Child

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exposure, Relaxation, & Rescripting Therapy-Child

Resource links provided by NLM:


Further study details as provided by University of Tulsa:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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: 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. ] [ Designated as safety issue: No ]
    The UPID screens for trauma exposure and posttraumatic symptoms among youth 7 to 18 years old. Queries types of trauma exposures, assesses for DSM-IV criteria of traumatic exposure and the past-month frequency of PTSD symptoms and 2 associated features of PTSD in childhood.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    The NDQ is a 13-item self-report measure of nightmare related distress. Higher scores are significantly related to interest in therapy for nightmares.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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).

  • 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. ] [ Designated as safety issue: No ]
    The CBCL can be completed by parents or parent-surrogates. It consists of 20 items that provide information regarding a child's competencies; 118 items assess both behavioral and emotional problems; and two open-ended questions for reporting additional problems.

  • 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. ] [ Designated as safety issue: No ]
    The CSHQ is a 33-item parent-report measure of sleep behavior that can be used by parents of children 4 to 12 years of age. 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.

  • 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. ] [ Designated as safety issue: No ]
    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).

  • 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. ] [ Designated as safety issue: No ]
    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").

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    The BRIEF is an 86-item measure that assesses different aspects of executive function behaviors in the home environment. There are eight different scales of executive function assessed within the measure.

  • Child Behavior Checklist - Teacher Form (CBCL-TR) [ Time Frame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks. ] [ Designated as safety issue: No ]
    This form of the CBCL is to be completed by the child's teacher. It consists of 20 items that provide information regarding a child's competencies within school; 113 items that assess both behavioral and emotional problems; and one open-ended question for reporting additional problems.

  • 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. ] [ Designated as safety issue: No ]
    The BRIEF is an 86-item measure that assesses different aspects of executive function behaviors in the school. There are eight different scales of executive function assessed within the measure.

  • 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. ] [ Designated as safety issue: No ]
    This is a computerized game that assesses attention. This measure presents a single fish or five fish in a horizontal row. Children are asked to respond to the center fish by pressing the left or right button on the computer mouse in the direction in which the fish is pointing.

  • 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. ] [ Designated as safety issue: No ]
    The Trail Making Test is a measure of visual attention and task switching. The test has two parts in which the child is instructed to connect a set of 25 dots as fast as possible while maintaining accuracy.

  • 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. ] [ Designated as safety issue: No ]
    This subtest from the "A Developmental NEuroPSYchological Assessment" (NEPSY) assesses the ability to formulate basic concepts, to transfer those concepts into action, and to shift set from one concept to another.

  • 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. ] [ Designated as safety issue: No ]
    This subtest from the NEPSY has two parts. The Attention Auditory assesses selective auditory attention and the ability to sustain it. The Response Set assesses the ability to shift and maintain a new and complex set involving both inhibition of previously learned responses and correctly responding to matching or contrasting stimuli.

  • 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. ] [ Designated as safety issue: No ]
    This subtest from the NEPSY assesses planning and organization, visuoperceptual and visuospatial skills, and the concept of time related to analog clocks.

  • 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. ] [ Designated as safety issue: No ]
    This device is the size of a wristwatch. It records movement, which can be used to better understand sleep quality and sleep cycles. If also has a button for tracking nightmares. It is not a requirement of the study to wear the actigraph.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral
Exposure, Relaxation, & Rescripting Therapy-Child utilizes behavioral and cognitive therapy techniques of exposure therapy and cognitive restructuring.
Behavioral: 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: Waitlist Control
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

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children age 5-12 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776229

Contacts
Contact: Jim A Scholl, B.A. 9186312543 jim-scholl@utulsa.edu
Contact: Lisa Cromer, PhD 9186312267 lisa-cromer@utulsa.edu

Locations
United States, Oklahoma
The University of Tulsa Institute for Trauma Abuse and Neglect Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Jim A Scholl, B.A.    918-631-2543    jim-scholl@utulsa.edu   
Contact: Lisa Cromer, PhD    9186312267    lisa-cromer@utulsa.edu   
Principal Investigator: Lisa Cromer, Phd         
Sub-Investigator: Joanne Davis, PhD         
Sponsors and Collaborators
University of Tulsa
Investigators
Principal Investigator: Lisa Cromer, Phd The University of Tulsa
  More Information

No publications provided

Responsible Party: Lisa Cromer, Assistant Professor of Psychology, University of Tulsa
ClinicalTrials.gov Identifier: NCT01776229     History of Changes
Other Study ID Numbers: TU1163
Study First Received: July 24, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tulsa:
nightmare
PTSD
trauma
children

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 17, 2014