Completed

NCT Number: NCT06548022

Rare Group Problem Management Plus

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.

Completed

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Post-traumatic Stress Disorder Problems Psychosocial Rare Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rare Group Problem Management Plus

Behavioral

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.

Primary outcomes

Acceptability

Time frame: 2 weeks post-intervention (Session 5)

As measured by retention at 2 weeks post-intervention assessment

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Collaborators

Travere Therapeutics, Inc.

Registry information

Acronym: Group PM+

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Aug 12, 2024
Registry last updated: Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed