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Behavioral Intervention

Group Therapy for Psychosocial Issues

N/A
Recruiting
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
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety
Secondary study objectives
Acceptability
Generalized Anxiety Disorder 7
Patient Health Questionnaire 9
+4 more

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

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Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
218 Previous Clinical Trials
257,880 Total Patients Enrolled
2 Trials studying Depression
2,450 Patients Enrolled for Depression
Travere Therapeutics, Inc.Industry Sponsor
22 Previous Clinical Trials
177,744 Total Patients Enrolled
~9 spots leftby Dec 2024
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