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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

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

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

Awards & 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

0 / 2Eligibility criteria met