An interventional study of Rare Group Problem Management Plus in Anxiety, Depressive Symptoms and Post-traumatic Stress Disorder, sponsored by Children's National Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Children's National Research Institute · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Children's National Research Institute is the lead sponsor of 124 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.
Exclusion Criteria:
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
Behavioral: Rare Group Problem Management Plus
The World Health Organization's Group Problem Management Plus (Group PM+) intervention has been demonstrated to effectively provide psychological help for adults impaired by distress in communities exposed to adversity. Investigators will test an adapted model for use on-line and with family caregivers of children with rare diseases. Managing Stress. Teaching participants a brief stress management strategy will help them better manage problems related to anxiety and stress. Managing Problems. This is a strategy to apply in situations where a participant is experiencing practical problems (e.g. conflict in the family). Get Going, Keep Doing. This strategy targets depression and inactivity. Strengthening Social Support. Individuals with emotional problems can be isolated from supportive people and organizations. Strengthening social support promotes well-being. Staying Well and Looking Forward. This is a review, ends with a closing ceremony.
Acceptability
As measured by retention at 2 weeks post-intervention assessment
Time frame: 2 weeks post-intervention (Session 5)
Plan to share: No — No individual participant data will be available to other researchers for this development and adaptation study.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Children's National Research Institute