- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03185247
Implementation of Transdx Group for POTS
September 24, 2019 updated by: University of Colorado, Denver
Implementation of a Transdiagnostic Psychological Group Intervention for Pediatric Autonomic Dysfunction
The proposed intervention is focused on developing and implementing a psychological approach incorporated into a group-based outpatient intervention for pediatric autonomic dysfunction.
The investigators hypothesize that their intervention will result in improvements in the transdiagnostic mechanisms specifically targeted by components of their intervention including sleep, information processing, and youth/parent experiential avoidance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
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
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
-
-
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
11 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Adolescent participants must be
- between the ages of 13-18 years old,
- english speaking, and
- have been diagnosed with autonomic dysfunction, dysautonomia, orthostatic intolerance, and/or POTS.
Participants must also:
- endorse symptoms of autonomic dysfunction on the COMPASS 31 (measures are described below), and show
- moderate functional impairment, and/or
- some psychiatric symptoms in the domains of anxiety and/or depression.
- FDI scores must be greater than 12 (see Kashikar-Zuck et al., 2011 for an empirical rationale).
- Must have attended at least one day of school per week during the past month.
- On the measures of anxiety (SCARED) and depression (CDI), the adolescent's scale score must be above the "average" range based on T scores (CDI) or within the "clinical" range (SCARED).
- Each participant must have at least one English-speaking parent/legal guardian who can provide informed consent for the adolescent, as well as participate in the study.
- Each adolescent and their parent/legal guardian(s) must be English-speaking.
Exclusion Criteria:
Adolescent participants;
- wards of the state,
- endorse active homicidal or suicidal ideation,
- have an intellectual disability, a pervasive developmental disability or significant developmental delay,
- endorse an active substance use disorder, and
- are currently participating in individual or group psychotherapy.
- do not have in-network health insurance that covers Health and Behavior interventions, or
- are unable to self-pay.
Parent/legal guardian(s) are
- unwilling to participate in the study,
- are non-English speaking, or
- have an intellectual disability, a pervasive developmental disability or significant developmental delay, and/or
- do not have legal custody of the adolescent participant.
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: Group Intervention
10-week parent-child multi-family group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline, 10 weeks, and 6-months
|
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.
|
Baseline, 10 weeks, and 6-months
|
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.
|
Baseline, 10 weeks, and 6-months
|
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.
|
Baseline, 10 weeks, and 6-months
|
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.
|
Baseline, 10 weeks, and 6-months
|
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…"
|
Baseline, 10 weeks, and 6-months
|
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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jessica Malmberg, PhD, University of Colorado/Children's Hospital Colorado
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 (Actual)
May 26, 2017
Primary Completion (Actual)
March 1, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
June 8, 2017
First Submitted That Met QC Criteria
June 9, 2017
First Posted (Actual)
June 14, 2017
Study Record Updates
Last Update Posted (Actual)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0470
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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