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Recruiting NCT05789446

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

No phase Interventional Chronic Stress Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Building a Strong Identity and Coping Skills.
Who it may be relevant to
Registry conditions: Chronic Stress, Anxiety, Depression. Basic parameters: from 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents

Overview

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

Interventions

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

Primary outcome measures

  • Anxiety [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]
  • Depression [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]
  • Suicide Risk Markers [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]
Secondary outcome measures (4)
  • Engagement Coping Skills Acquisition [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]
  • HPA Reactivity Profile [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]
  • Collaborative Coping [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]
  • Sociocultural Identity Development [Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)]

Eligibility criteria

Inclusion criteria

  • Children ages 11-14 at intake
  • Family income at or below 200% federal poverty level
  • Child speaks English
  • Parent speaks English or Spanish

Exclusion criteria

  • Intellectual disability
  • Autism spectrum disorder
  • High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
  • Severe depression (score of 19 or more on Patient health questionnaire (PHQ).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 5 centers
  • Pennsylvania Psychiatric Institute — Harrisburg
  • Penn State Health Medical Group - Psychiatry and Behavioral Health — Hershey
  • Penns Valley Area School District — Spring Mills
  • Dr. Edwin L. Herr Clinic — State College
  • Penn State Psychological Clinic — State College

Identifiers

NCT: NCT05789446 · PAR-21-132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗