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Culturally Adapted Program for Anxiety and Depression (NPC Trial)
N/A
Recruiting
Research Sponsored by Montana State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-10 minutes
Awards & highlights
NPC Trial Summary
This trial will adapt a prevention and early intervention program for anxiety and depression for use with Native American youth, in order to better address the needs of this population.
Who is the study for?
This trial is for Native American youth aged 8-12 living on a Northern Plains tribal reservation, their parents, teachers at tribe-serving schools, mental health specialists serving the reservation or school, and elders residing on the reservation. Participants must be directly involved with the culturally adapted intervention.Check my eligibility
What is being tested?
The trial tests 'Culturally Adapted Compass for Courage', aiming to reduce anxiety and depression in Native American youth. It involves cultural adaptation by community members and mixed method evaluation of feasibility, acceptability, and changes in symptoms.See study design
What are the potential side effects?
As this is a psychological intervention involving culturally adapted prevention strategies rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience emotional discomfort during discussions.
NPC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5-10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-10 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Revised Child Anxiety and Depression Scale - Short Version
Secondary outcome measures
Anxiety Control Questionnaire for Children
Child Response Style Questionnaire - Rumination Scale
The Child and Youth Resilience Measure
Other outcome measures
Post-Intervention Usability Survey
NPC Trial Design
1Treatment groups
Experimental Treatment
Group I: Culturally Adapted Compass for CourageExperimental Treatment1 Intervention
All youth will receive the culturally adapted Compass for Courage from Native American providers in the school setting.
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Who is running the clinical trial?
National Institute of General Medical Sciences (NIGMS)NIH
272 Previous Clinical Trials
246,890 Total Patients Enrolled
9 Trials studying Depression
2,141 Patients Enrolled for Depression
Montana State UniversityLead Sponsor
44 Previous Clinical Trials
1,043,714 Total Patients Enrolled
8 Trials studying Depression
2,170 Patients Enrolled for Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 8-12 years old, go to a tribe-serving school, and live on the reservation with my guardian.I am a parent of a child aged 8-12 living on the reservation.I am a parent of a child aged 8-12 who joined the adapted program.I teach kids aged 8-12 and have used the adapted program.I teach 3rd to 6th grade at a school serving tribal communities.
Research Study Groups:
This trial has the following groups:- Group 1: Culturally Adapted Compass for Courage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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