Clinical trial NCT06548022: Rare Group Problem Management Plus
Official title: Rare Group Problem Management Plus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depressive Symptoms
Post-traumatic Stress Disorder
Problems Psychosocial
Keywords: rare disease
pediatric
family caregiver
psychoeducation
group intervention
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Travere Therapeutics, Inc.
First posted: 2024-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, pre/post-test design.
Primary purpose: TREATMENT

Brief summary: Participants are being asked to be in the study if they are the parent or legal guardian of a child (\>1 year or \<18 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management Plus.

Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)

Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour.

Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this.

Participants will not receive any materials or money or medication.

Detailed description: Participants are being asked to be in the study because they are the parent or legal guardian of a child (infancy up to 21 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management (PM) Plus intervention.

Rare Group PM Plus may help adults with practical and emotional problems It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)

Investigators will be recruiting for 3 groups of 10 families each, for a total of 30 families who will participate in this study from Children's National Hospital.

There are 7 study visits.

Study Timeline:

Study visit 1: Assessment-Before Group PM+ Study visit 2: Session 1-Managing Stress Study visit 3: Session 2-Managing Problems Study visit 4: Session 3-Get Going, Keep Doing Study visit 5: Session 4-Strengthening Social Support Study Visit 6: Session 5-Staying Well and Looking Forward Study Visit 7: Assessment within 2 weeks after complete Group PM+

Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee.

Investigators will use chi-square tests and Fisher's exact test to measure changes from baseline to 2 weeks post-intervention. Investigators will also collect qualitative data on what participants liked about the intervention, what they did not like, and what they think will improve the intervention.

Eligibility criteria: Inclusion Criteria:

* • Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.

  * Understands and speaks English or Spanish. Reading or health literacy is not required.
  * Signed consent.
  * Signed waiver of assent for child.

Exclusion Criteria:

* Family caregiver is under the age of 18 years.
* Child with the rare disease is over the age of 21 years.
* Family caregiver is actively suicidal, homicidal, or psychotic.
* Family caregiver is impaired (cognitively or by drugs or alcohol).
* Family caregiver has a low level of distress.

Primary outcomes:
measure: Acceptability
timeFrame: 2 weeks post-intervention (Session 5)
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Maureen Lyon, PhD
role: PRINCIPAL_INVESTIGATOR
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