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

Conditions

• Anxiety
• Chronic Stress
• Depression

Eligibility Criteria

Sex

ALL

Age

11 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Building a Strong Identity and Coping Skills — BEHAVIORAL
  Psychoeducational program to teach children coping skills, healthy identity development, and collective social action

Study Details

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

Key Dates

Start date

Feb 1, 2025

Status verified

Apr 2025

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BaSICS 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.
• No Intervention: Control
  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.

Primary Outcome Measure

Anxiety [ Time Frame: Pre-post (3 months) and Pre-follow up (6 and 12 months) ]

Central Contacts

• Martha E Wadsworth, PhD
  814-865-2878
  [email protected]
• Dara Babinksi, PhD
  [email protected]

Locations (5)

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