ACTIVE_NOT_RECRUITING

Rare Group Problem Management Plus

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Rare Group Problem Management Plus

Quick Facts

Study Start:2024-02-05
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06548022

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.
  2. * Understands and speaks English or Spanish. Reading or health literacy is not required.
  3. * Signed consent.
  4. * Signed waiver of assent for child.
  1. * Family caregiver is under the age of 18 years.
  2. * Child with the rare disease is over the age of 21 years.
  3. * Family caregiver is actively suicidal, homicidal, or psychotic.
  4. * Family caregiver is impaired (cognitively or by drugs or alcohol).
  5. * Family caregiver has a low level of distress.

Contacts and Locations

Principal Investigator

Maureen Lyon, PhD
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Maureen Lyon, PhD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

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 Registration Dates

Study Start Date2024-02-05
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Anxiety
  • Depressive Symptoms
  • Post-traumatic Stress Disorder
  • Problems Psychosocial