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Behavioral Intervention
Group Therapy for Psychosocial Issues (Group PM+ Trial)
N/A
Recruiting
Led By Maureen Lyon, PhD
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Family caregiver is under the age of 18 years
Child with the rare disease is over the age of 21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-intervention (session 5)
Awards & highlights
No Placebo-Only Group
Summary
"This trial is looking for parents or legal guardians of children with a rare condition to participate in a group program called Rare Group Problem Management Plus. The program aims to help adults with practical and emotional problems related
Who is the study for?
This trial is for parents or guardians of children aged 1 to 17 with a rare condition. They should be able to attend weekly group sessions via telemedicine using a smartphone or tablet, which the study team can assist in providing if necessary.
What is being tested?
The intervention being tested is called Rare Group Problem Management Plus, a psychoeducational program aimed at helping adults manage practical and emotional challenges through weekly group sessions over five weeks.
What are the potential side effects?
Since this is a psychoeducational intervention without medication, there are no direct medical side effects. However, discussing sensitive topics may cause temporary emotional discomfort.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My family caregiver is younger than 18.
Select...
My child with a rare disease is older than 21.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post-intervention (session 5)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-intervention (session 5)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Secondary study objectives
Generalized Anxiety Disorder 7
Patient Health Questionnaire 9
Post Traumatic Stress Disorder DSM-5 Checklist
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Rare Group PM PlusExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Children's National Research InstituteLead Sponsor
223 Previous Clinical Trials
258,365 Total Patients Enrolled
Travere Therapeutics, Inc.Industry Sponsor
22 Previous Clinical Trials
102,675 Total Patients Enrolled
Maureen Lyon, PhDPrincipal InvestigatorChildren's National Research Institute