Rare Group Problem Management Plus

NCT06548022 | Completed

• 1 other identifier: IRBear Protocol # 1049
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

rare disease; pediatric; family caregiver; psychoeducation; group intervention

Outcome Measures

Primary Outcomes (1)

• Acceptability

  As measured by retention at 2 weeks post-intervention assessment

  2 weeks post-intervention (Session 5)

Study Arms (1)

Rare Group PM Plus

EXPERIMENTAL

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

Interventions

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.

Rare Group PM Plus

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead
• Travere Therapeutics, Inc.: collaborator

Study Sites (1)

Children's National Hospital

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

Location

Related Publications (31)

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  BACKGROUND

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• Ali AM, Schwalk DE, Lyon ME. Adapting and Beta Testing Rare Group Problem Management Plus for Family Caregivers of Children with Rare Diseases. (April 30, 2025). Poster. 2025 Awardee Medical Student Research Day, Abdulla Ali, in the category of Clinical and Translational Research. George Washington University School of Medicine and Health Sciences, Washington DC.

  RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Rare Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maureen Lyon, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Health Psychologist

Model Details: Single group, pre/post-test design.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 12, 2024
• Study Start: February 5, 2024
• Primary Completion: June 25, 2025
• Study Completion: November 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)