Rare Group Problem Management Plus (Group PM+)

March 25, 2026 updated by: Maureen Lyon, Children's National Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Children's National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 2 weeks post-intervention (Session 5)
As measured by retention at 2 weeks post-intervention assessment
2 weeks post-intervention (Session 5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 2 weeks post-intervention
As measured retention rate of greater than 85% at 2 weeks post-intervention.
2 weeks post-intervention
Satisfaction Questionnaire
Time Frame: 2 weeks post-intervention
As measured by the 13 item Satisfaction Questionnaire. Responses are on a 5 point Likert scale ranges from Strongly agree to Strongly disagree. Minimum and maximum values are 13 to 65. Higher score indicates greater satisfaction with study participation.
2 weeks post-intervention
Generalized Anxiety Disorder 7
Time Frame: Baseline and 2 weeks post-intervention
Measure of symptoms of anxiety. 7 items scored from 0 to 3. 0=not at all. 3=nearly every day. Scale scores range from 0-21. Higher score indicates worse outcome.
Baseline and 2 weeks post-intervention
Patient Health Questionnaire 9
Time Frame: Baseline and 2 weeks post-intervention
Measure of symptoms of depression and suicidal ideation. 9 items scored from 0-3. )=not at all. 3=nearly every day. Scale scores range from 0-27. Higher score indicates worse outcome.
Baseline and 2 weeks post-intervention
Post Traumatic Stress Disorder DSM-5 Checklist
Time Frame: Baseline and 2 weeks post-intervention
Measure of symptoms of PTSD. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating. Score ranges from 0-80. Scores of 33 or higher may indicate severe PTSD. Higher score indicates worse outcome.
Baseline and 2 weeks post-intervention
WHO Disability Assessment Schedule 2.0
Time Frame: Baseline and 2 weeks post-intervention.
This 12-item version of the WHODAS 2.0 asks about difficulties due to health conditions over the past 30 days. Responses range from None to Extreme or cannot due on a 5-point Likert scale. Higher scores indicate worse outcomes.
Baseline and 2 weeks post-intervention.
Psychological Outcome Profiles
Time Frame: Baseline and 2 weeks post-intervention
the PSYCHOLOPS is a measure of up to 3 participant's problem(s) and how much it has affected them. Not affected at all to Severely affected, a six point scale ranging from zero to five. Pre-intervention score is compared to post-intervention scores. Only the questions relating to Problems, Functioning, and Well-being are scored. The maximum score for each question is 5. The maximum PSYCHLOPS score is 20. Higher scores indicate worse outcomes.
Baseline and 2 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Collaborators

Travere Therapeutics, Inc.

Investigators

  • Principal Investigator: Maureen Lyon, PhD, Children's National Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Actual)

June 25, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 5, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBear Protocol # 1049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be available to other researchers for this development and adaptation study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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