Rare Group Problem Management+
NCT Number: NCT06548022
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Depressive Symptoms|Post-traumatic Stress Disorder|Problems Psychosocial
Interventions: BEHAVIORAL: Rare Group Problem Management Plus
Sponsor: Children's National Research Institute
Collaborators: Travere Therapeutics, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-05
Completion Date: 2025-01-31
Locations: Children's National Hospital, Washington, District of Columbia, 20010, United States

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.

Primary Outcome Measures: Safety, As measured by # of participants with treatment related adverse events as assessed by the Satisfaction Questionnaire, i.e. responding agree or strongly agree that intervention was harmful, hurtful, and disagreeing or strongly disagreeing that it was worthwhile and/or satisfactory., 2 weeks post-intervention
Secondary Outcome Measures: Acceptability, As measured retention rate of greater than 85% at 2 weeks post-intervention., 2 weeks post-intervention|Satisfaction Questionnaire, As measured by the 13 item Satisfaction Questionnaire. Responses are on a 5 point Likert scale ranges from Strongly agree to Strongly disagree. Minimum and maximum values are 13 to 65. Higher score indicates greater satisfaction with study participation., 2 weeks post-intervention|Generalized Anxiety Disorder 7, Measure of symptoms of anxiety. 7 items scored from 0 to 3. 0=not at all. 3=nearly every day. Scale scores range from 0-21. Higher score indicates worse outcome., Baseline and 2 weeks post-intervention|Patient Health Questionnaire 9, Measure of symptoms of depression and suicidal ideation. 9 items scored from 0-3. )=not at all. 3=nearly every day. Scale scores range from 0-27. Higher score indicates worse outcome., Baseline and 2 weeks post-intervention|Post Traumatic Stress Disorder DSM-5 Checklist, Measure of symptoms of PTSD. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating. Score ranges from 0-80. Scores of 33 or higher may indicate severe PTSD. Higher score indicates worse outcome., Baseline and 2 weeks post-intervention|WHO Disability Assessment Schedule 2.0, This 12-item version of the WHODAS 2.0 asks about difficulties due to health conditions over the past 30 days. Responses range from None to Extreme or cannot due on a 5-point Likert scale. Higher scores indicate worse outcomes., Baseline and 2 weeks post-intervention.|Psychological Outcome Profiles, the PSYCHOLOPS is a measure of up to 3 participant's problem(s) and how much it has affected them. Not affected at all to Severely affected, a six point scale ranging from zero to five. Pre-intervention score is compared to post-intervention scores. Only the questions relating to Problems, Functioning, and Well-being are scored. The maximum score for each question is 5. The maximum PSYCHLOPS score is 20. Higher scores indicate worse outcomes., Baseline and 2 weeks post-intervention