Clinical trial NCT02184026: Exposure, Relaxation, & Rescripting Therapy-Child
Official title: Exposure, Relaxation, & Rescripting Therapy-Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Trauma Nightmares
Traumatic Stress
Keywords: nightmare
PTSD
trauma
children
Children Age 8 to 13
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 2
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

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 follow-ups at 3 months & 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-IV (DSM-IV) (UPID)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Nightmare Distress Questionnaire - Modified (NDQ)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Strength and Difficulties Questionnaire - Child Version (SDQ)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Strengths and Difficulties Questionnaire - Parent Version (SDQ)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: The Parenting Stress Scale (PSS)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Pittsburgh Sleep Quality Index - Parent self-report (PSQI)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: The McMaster Family Assessment Device (FAD)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Academic Grade Point Average (GPA)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Other outcomes:
measure: Trail Making Test
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Wechsler Intelligence Scale for Children (WISC-IV), Letter-Number Sequencing subtest
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Wechsler Intelligence Scale for Children (WISC-IV), Digit Span subtest
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Child Attention Network Task
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: A Developmental NEuroPSYchological Assessment (NEPSY-II), Animal Sorting subtest
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: A Developmental NEuroPSYchological Assessment (NEPSY-II), Auditory Attention & Response Set subtest
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: A Developmental NEuroPSYchological Assessment (NEPSY-II), Clocks subtest
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Aimsweb Reading Curriculum-Based Measurement (R-CBM)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Aimsweb MAZE Reading Curriculum-Based Measurement (MAZE-CBM)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
measure: Peabody Picture Vocabulary Test, Fourth Edition (PPVT-4)
timeFrame: 1 wk pre-treatment & 1 wk, 3 mo, 6 mo post-treatment follow-ups
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
affiliation: University of Montana
name: Cameo Borntrager, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: