Clinical trial NCT03185247: Implementation of Transdx Group for POTS
Official title: Implementation of a Transdiagnostic Psychological Group Intervention for Pediatric Autonomic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysautonomia
Anxiety
Depression
Keywords: Transdiagnostic
POTS (Postural Orthostatic Tachycardia Syndrome)
Therapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 16
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adolescent participants must be

  1. between the ages of 13-18 years old,
  2. english speaking, and
  3. have been diagnosed with autonomic dysfunction, dysautonomia, orthostatic intolerance, and/or POTS.
* Participants must also:

  1. endorse symptoms of autonomic dysfunction on the COMPASS 31 (measures are described below), and show
  2. moderate functional impairment, and/or
  3. 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;

  1. wards of the state,
  2. endorse active homicidal or suicidal ideation,
  3. have an intellectual disability, a pervasive developmental disability or significant developmental delay,
  4. endorse an active substance use disorder, and
  5. are currently participating in individual or group psychotherapy.
  6. do not have in-network health insurance that covers Health and Behavior interventions, or
  7. are unable to self-pay.
* Parent/legal guardian(s) are

  1. unwilling to participate in the study,
  2. are non-English speaking, or
  3. have an intellectual disability, a pervasive developmental disability or significant developmental delay, and/or
  4. do not have legal custody of the adolescent participant.

Primary outcomes:
measure: Change in Composite Autonomic Symptom Score (self-report)
timeFrame: Baseline, 10 weeks, and 6-months
measure: Change in Functional Disability Inventory (caregiver and self-report)
timeFrame: Baseline, 10 weeks, and 6-months
measure: Change in Children's Depression Inventory (caregiver and self-report)
timeFrame: Baseline, 10 weeks, and 6-months
measure: Change in Screen for Childhood Anxiety Related Emotional Disorders (caregiver and self-report)
timeFrame: Baseline, 10 weeks, and 6-months
measure: Change in Transdiagnostic Youth/Parent Questionnaire
timeFrame: Baseline, 10 weeks, and 6-months
measure: Change in Pain Coping Questionnaire (caregiver and self-report)
timeFrame: Baseline, 10 weeks, and 6-months
measure: Satisfaction Questionnaire (caregiver and self-report)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado/Children's Hospital Colorado
name: Jessica Malmberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: