Implementation of Transdx Group for POTS
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|ClinicalTrials.gov Identifier: NCT03185247|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2017
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dysautonomia Anxiety Depression||Behavioral: Transdiagnostic Group-Based Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation of a Transdiagnostic Psychological Group Intervention for Pediatric Autonomic Dysfunction|
|Actual Study Start Date :||May 26, 2017|
|Actual Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Group Intervention
10-week parent-child multi-family group
Behavioral: Transdiagnostic Group-Based Treatment
10 week 90-minute weekly therapy sessions including both the adolescent and caregiver. Treatment will consist of psychoeducation about dysautonomia, motivational interviewing techniques to promote readiness for change, support around lifestyle and behavioral changes, core CBT components (e.g., relaxation training, linking thoughts, feelings, and behaviors, minimizing catastrophizing thoughts, cognitive coping, and exposure), and components of ACT aiming to increase cognitive flexibility (e.g., mindfulness, experiential avoidance, values, cognitive defusion, committed action), and relapse prevention and maintenance. Most sessions will involve homework assigned to the adolescent and their parent/legal guardian(s) to encourage practice at home.
- Change in Composite Autonomic Symptom Score (self-report) [ Time Frame: Baseline, 10 weeks, and 6-months ]This is a 31 item self-report measure developed to assess autonomic symptoms (e.g., dizziness, orthostatic intolerance, nausea, sweating).
- Change in Functional Disability Inventory (caregiver and self-report) [ Time Frame: Baseline, 10 weeks, and 6-months ]This is a measure that evaluates children's difficulty in physical and psychosocial functioning due to their physical health. The instrument consists of 15 items that assess self-perceptions of activity limitations during the past 2 weeks.
- Change in Children's Depression Inventory (caregiver and self-report) [ Time Frame: Baseline, 10 weeks, and 6-months ]This is a 27-item self-report measure designed to assess cognitive, behavioral, and affective symptoms of depression.
- Change in Screen for Childhood Anxiety Related Emotional Disorders (caregiver and self-report) [ Time Frame: Baseline, 10 weeks, and 6-months ]This measure is used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. In addition, it assesses symptoms related to school refusal. The SCARED consists of 41 items.
- Change in Transdiagnostic Youth/Parent Questionnaire [ Time Frame: Baseline, 10 weeks, and 6-months ]Our team developed these comprehensive questionnaires to assess transdiagnostic mechanisms in the present study. These questionnaires comprise full measures and/or subscales drawn from several well-validated and psychometrically-sound measures that are available as part of the public domain and/or that were provided for open access by the developers of the measure, and that have been previously designed and validated to measure each of the mechanisms of interest. These mechanisms include emotion regulation, experiential avoidance, sleep, peer acceptance/rejection, parenting, and information processing.
- Change in Pain Coping Questionnaire (caregiver and self-report) [ Time Frame: Baseline, 10 weeks, and 6-months ]For the current study, this measure has been adapted to ask about "physical illness symptoms" rather than pain. The adapted measure asks adolescents/caregivers to indicate how often (1 = never to 5 = very often) they/their child used each of 39 coping strategies when responding to prompts such as, "When I am experiencing autonomic symptoms for a few hours or days, I…"
- Satisfaction Questionnaire (caregiver and self-report) [ Time Frame: 10 weeks ]This is an 8-item measure intended to assess satisfaction, perceived benefits, and likelihood of recommending the program. Items, which include "How would you rate the quality of care you have received?" are rated on a 1 to 4 Likert-scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185247
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Jessica Malmberg, PhD||University of Colorado/Children's Hospital Colorado|