Group program for parents of children with rare conditions
Rare Group Problem Management Plus
NA · Children's National Research Institute · NCT06548022
This study is testing a group program for parents of children with rare conditions to see if sharing experiences and learning new strategies can help them cope better with their challenges.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Children's National Research Institute (other) |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT06548022 on ClinicalTrials.gov |
What this trial studies
This intervention involves a group-based psychoeducational program called Rare Group Problem Management Plus, designed for family caregivers of children with rare diseases. The program consists of five weekly sessions, each lasting 90 minutes, where participants can share experiences and learn strategies to manage practical and emotional challenges. Assessments will be conducted before and after the program to evaluate its effectiveness, and sessions will be held via Telemedicine. The study aims to recruit 30 families from Children's National Hospital to participate in this supportive intervention.
Who should consider this trial
Good fit: Ideal candidates are family caregivers aged 18 or older of children with rare diseases, from infancy to 21 years old.
Not a fit: Patients who may not benefit include caregivers under 18, those whose children are over 21, or caregivers experiencing severe mental health issues.
Why it matters
Potential benefit: If successful, this program could provide essential support and coping strategies for caregivers of children with rare conditions.
How similar studies have performed: While similar group interventions have shown promise in supporting caregivers, this specific approach targeting rare conditions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington, District of Columbia
- Children's National Hospital — Washington, District of Columbia, United States (RECRUITING)
Study contacts
- Principal investigator: Maureen Lyon, PhD — Children's National Research Institute
- Study coordinator: Maureen E Lyon, PhD
- Email: mlyon@childrensnational.org
- Phone: 703-346-2873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety, Depressive Symptoms, Post-traumatic Stress Disorder, Problems Psychosocial, rare disease, pediatric, family caregiver, psychoeducation