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Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from May 31, 2029 to May 31, 2030 Eligibility criteria expanded, about 8 words · Secondary endpoints: details revised at 3 of 4 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 4 entries
  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 1, 2029 to May 31, 2029 · Completion date: Aug 30, 2029 to May 31, 2029 · Site details revised at 5 of 5 sitesv4 Show 3 more changesShow less
    • Primary completion date: Jan 1, 2029 to May 31, 2029
    • Completion date: Aug 30, 2029 to May 31, 2029
    • Site details revised at 5 of 5 sites
  3. Primary completion date: Dec 31, 2027 to Jan 1, 2029 Start date: Feb 1, 2024 to Feb 1, 2025 · Completion date: Dec 31, 2028 to Aug 30, 2029v3 Show 2 more changesShow less
    • Start date: Feb 1, 2024 to Feb 1, 2025
    • Completion date: Dec 31, 2028 to Aug 30, 2029
  4. Start date: Jan 1, 2024 to Feb 1, 2024 Primary endpoints revised (3) · Secondary endpoints: 6 to 4 · Study arms: 3 to 2v2 Show 3 more changesShow less
    • Primary endpoints revised (3)
    • Secondary endpoints: 6 to 4
    • Study arms: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Penn State University
81 trials monitored
See 9 trials at risk
Depression
2,998 trials monitored
See 166 trials at risk
Anxiety
2,264 trials monitored
See 97 trials at risk
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 minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services. The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration. Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles
Trial Details
NCT Number NCT05789446
Lead Sponsor Penn State University
Conditions Chronic Stress, Anxiety, Depression
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov