Rare Group Problem Management+
Purpose
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.
Conditions
- Anxiety
- Depressive Symptoms
- Post-traumatic Stress Disorder
- Problems Psychosocial
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single group, pre/post-test design.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rare Group PM 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 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Children's National Research Institute
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. We 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.
