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Coping Skills Program for Depression
N/A
Waitlist Available
Led By Martha E Wadsworth, PhD
Research Sponsored by Penn 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 pre-post (3 months) and pre-follow up (6 and 12 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a program to help low-income and minoritized youth aged 11-14 reduce symptoms of anxiety, depression, and PTSD. It will assess changes in coping mechanisms, symptom change, and biological "risk".
Who is the study for?
This trial is for English-speaking children aged 11-14 from low-income families who are experiencing chronic stress, depression, or anxiety. They must not have an intellectual disability, autism spectrum disorder, high suicidal risk, or severe depression.
What is being tested?
The study tests the 'Building a Strong Identity and Coping Skills' (BaSICS) program on youth waiting for mental health treatment. It aims to replicate previous positive results and examine changes in coping skills and stress response systems.
What are the potential side effects?
Since BaSICS is a psychological intervention rather than medication, side effects may include emotional discomfort during sessions but typically do not involve physical side effects like those seen with drugs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-post (3 months) and pre-follow up (6 and 12 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-post (3 months) and pre-follow up (6 and 12 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety
Depression
Suicide Risk Markers
Secondary study objectives
Collaborative Coping
Engagement Coping Skills Acquisition
HPA Reactivity Profile
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BaSICS InterventionExperimental Treatment1 Intervention
Intervention = Building a String Identity and Coping Skills (BaSICS). Children randomized to participate in 16 twice weekly BaSICS intervention sessions. Children learn coping skills, identity development, and collective action as ways to buffer against chronic stress.
These children also complete pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments.
Group II: ControlActive Control1 Intervention
These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments. No intervention.
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Who is running the clinical trial?
Penn State UniversityLead Sponsor
368 Previous Clinical Trials
127,231 Total Patients Enrolled
Martha E Wadsworth, PhDPrincipal InvestigatorPenn State University
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe depression, as indicated by my PHQ score.I am between 11 and 14 years old.My child speaks English.I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: BaSICS Intervention
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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