Coping Skills Program for Depression

Recruiting at 4 trial locations

Overseen By Dara Babinksi, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Intellectual disability, Autism, High suicidal risk, Severe depression

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 8 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Building a Strong Identity and Coping Skills (BaSICS) program can assist young people experiencing anxiety, depression, or stress. The program targets low-income youth aged 11-14 who are awaiting mental health services. Participants will be divided into two groups: one will participate in the BaSICS program, while the other will not, to assess the program's effectiveness in enhancing coping skills and reducing stress. Ideal candidates are English-speaking children from low-income families who do not have severe depression or high-risk suicidal thoughts. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could benefit many young people in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BaSICS program is safe for youth?

Studies have shown that the Building a Strong Identity and Coping Skills (BaSICS) program helps children manage stress, anxiety, and depression. Research indicates that participants in the program did well, with no major safety concerns reported. The program teaches coping skills and helps children build a positive sense of self, reducing stress and anxiety.

As the program is not a drug or medical procedure, it doesn't carry the same risks as medications. Instead, it involves learning new skills in a supportive environment, making it generally safe and well-tolerated for children. Prospective participants should find this information reassuring regarding the program's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BaSICS (Building a Strong Identity and Coping Skills) program for depression because it takes a unique approach by focusing on identity development and coping skills rather than relying on medication. Unlike standard treatments like antidepressants or cognitive-behavioral therapy, BaSICS emphasizes collective action and personal empowerment, teaching children how to manage chronic stress through interactive sessions. This method could offer a fresh perspective and additional support for young people in building resilience against depression.

What evidence suggests that the BaSICS program is effective for treating depression?

Research has shown that the Building a Strong Identity and Coping Skills (BaSICS) program, which participants in this trial may receive, helps young teens manage stress better. One study found that kids who participated in BaSICS experienced fewer symptoms of anxiety and depression. The program teaches coping skills and helps kids build a strong personal and cultural identity. It also aims to reduce physical stress reactions, particularly those related to the body's stress response system. Early results suggest that kids in the program learn to handle stress more effectively, improving their overall mental health. These findings support BaSICS as a promising approach for helping young people with mental health challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Martha E Wadsworth, PhD

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Family income at or below 200% federal poverty level

I am between 11 and 14 years old.

Exclusion Criteria

Intellectual disability

High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))

I have severe depression, as indicated by my PHQ score.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group complete 16 twice-weekly BaSICS sessions focusing on coping skills, identity development, and collective action

8 weeks

16 sessions (in-person)

Follow-up

Participants complete pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments to monitor changes in anxiety, depression, coping skills, and HPA reactivity

12 months

3 follow-up assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Building a Strong Identity and Coping Skills

Trial Overview 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.

How Is the Trial Designed?

Group I: BaSICS Intervention Experimental Treatment 1 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: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Published Research Related to This Trial

The Teaching Kids to Cope (TKC) program is a 10-week psychoeducational intervention that has shown promising results in reducing depressive symptoms and enhancing coping skills among adolescents.

While initial findings are positive, further research with larger groups is necessary to fully assess the effectiveness of the TKC intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching kids to cope: a preventive mental health nursing strategy for adolescents. Puskar, KR., Lamb, J., Tusaie-Mumford, K.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10228347/

Initial Efficacy of the BaSICS Intervention for Early ... This proof-of-concept study tests the initial efficacy of the Building a Strong Identity and Coping Skills (BaSICS) intervention, a selective prevention of ...

2. careslab.la.psu.edu careslab.la.psu.edu/research/building-a-strong-identity-and-coping-skills-basics-projects/

Building a Strong Identity and Coping Skills (BaSICS) The BaSICS Program seeks to help children develop positive personal and cultural identities and to learn healthy ways of dealing with the stress in their lives.

3. reporter.nih.gov reporter.nih.gov/project-details/11142510

Project Details - NIH RePORTER The Building a Strong Identity and Coping Skills (BaSICS) program is a trauma- informed coping and empowerment intervention for early adolescents exposed to ...

4. withpower.com withpower.com/trial/phase-chronic-stress-2024-1e634

Coping Skills Program for Depression The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and ...

5. adaa.trialstoday.org adaa.trialstoday.org/?page=eJyLVspLrShR0lHycw4xMDEztrA0MVPS0bWEAR1jPUNDczMTEx1DcxNjEzNTMwMQ0FHKSy4xMLM0MDA3NFKKBQBIAw_l

Anxiety & Depression Association of America Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program. Penn State University Chronic Stress Anxiety Depression. The goal of this ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10786006/

The social determinants of mental health and disorder In this paper we provide a roadmap to address the social determinants that cause mental ill health.

7. csc.la.psu.edu csc.la.psu.edu/research/funded-research-projects/confirmatory-efficacy-of-the-building-a-strong-identity-and-coping-skills-program-for-low-income-adolescents-basics-2/

Confirmatory Efficacy of the Building a Strong Identity and ... The current project aims to replicate and extend the findings from the initial efficacy trial of BaSICS where, relative to control group, youth randomized to ...

8. adaa.trialstoday.org adaa.trialstoday.org/?page=eJyLViooSi3LzC8tVtJR8nMOMTAxM7awNDFT0tG1hAEdYz1DQzNLEyMdQ3MTA3MLcyMDENBRyksuMTA1NzAwNzNQigUAxMMRow--

Anxiety & Depression Association of America Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program. Penn State University Chronic Stress Anxiety Depression. The goal of this ...