Rare Group Problem Management Plus
- Conditions
- AnxietyDepressive SymptomsPost-traumatic Stress DisorderProblems Psychosocial
- Interventions
- Behavioral: Rare Group Problem Management Plus
- Registration Number
- NCT06548022
- Lead Sponsor
- Children's National Research Institute
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
-
ā¢ 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rare Group PM Plus Rare Group Problem Management Plus Rare Group PM Plus consists of 5 weekly sessions. Each session lasts 90 minutes. Session 1: Managing Stress Session 2: Managing Problems Session 3: Get Going, Keep Doing Session 4: Strengthening Social Support Session 5: Staying Well and Looking Forward
- Primary Outcome Measures
Name Time Method Acceptability 2 weeks post-intervention (Session 5) As measured by retention at 2 weeks post-intervention assessment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's National Hospital
šŗšøWashington, District of Columbia, United States