Clinical trial NCT01776229: Exposure, Relaxation, & Rescripting Therapy-Child
Official title: Exposure, Relaxation, & Rescripting Therapy-Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmares Associated With Trauma and Stress
Keywords: nightmare
PTSD
trauma
children
cognitive behavior therapy
stress
sleep
Lead sponsor: University of Tulsa
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Trauma Related Nightmare Survey - Child Version (TRNS-C) Reflecting change in nightmare frequency, severity, and duration.
timeFrame: 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)
timeFrame: 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.
measure: Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: 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.
measure: Nightmare Distress Questionnaire - Modified (NDQ)
timeFrame: 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.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 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.
measure: Strengths and Difficulties Questionnaire - Child Version (SDQ)
timeFrame: 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.
measure: Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
timeFrame: 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.
measure: Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)
timeFrame: 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.
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: 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.
measure: Strengths and Difficulties Questionnaire - Parent Version (SDQ)
timeFrame: 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.
measure: The Parenting Stress Scale (PSS)
timeFrame: 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.
measure: Pittsburgh Sleep Quality Index - Parent self-report (PSQI)
timeFrame: 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.
measure: The McMaster Family Assessment Device (FAD)
timeFrame: 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.
measure: Behavior Rating Inventory of Executive Function - Parent Form (BRIEF)
timeFrame: 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.
measure: Child Behavior Checklist - Teacher Form (CBCL-TR)
timeFrame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks.
measure: Behavior Rating Inventory of Executive Function - Teacher Form (BRIEF)
timeFrame: Participants will be assessed immediately after treatment which occurs on average for 5 weeks.
measure: Child Attention Network Task (Child ANT)
timeFrame: 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.
measure: Trail Making Test
timeFrame: 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.
measure: Animal Sorting
timeFrame: 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.
measure: Auditory Attention and Response Set
timeFrame: 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.
measure: Clocks
timeFrame: 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.
measure: Actiwatch-2 Wrist Monitor
timeFrame: 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.
measure: Letter-Number Sequencing
timeFrame: 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.
measure: Digit span
timeFrame: 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.
measure: R-CBM
timeFrame: 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.
measure: MAZE
timeFrame: 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.
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: The University of Tulsa Institute for Trauma Abuse and Neglect
state: Oklahoma
Study officials:
affiliation: The University of Tulsa
name: Lisa Cromer, Phd
role: PRINCIPAL_INVESTIGATOR
References: