Preventing Internalizing in Preadolescents Exposed to Chronic Stress

NCT02764138 | Completed DMC

• 1 other identifier: R33MH107631
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Racial and socioeconomic disparities in physical and mental health problems are large, persistent, and severe; begin during childhood; and stem from in part damage to physiologic stress response systems caused by chronic stress. Discovery of ways to prevent and/or halt this progression of damage to a child's stress response system may offer new directions for combatting health disparities. This project will evaluate the efficacy of a new prevention program designed to teach preadolescent children effective ways for coping with chronic stress that will have direct effects on their physiologic stress response systems (hypothalamic-pituitary-adrenal axis) and ultimately prevent onset of anxiety, depression, and post-traumatic stress symptoms and disorders.

Conditions

Chronic Stress; Anxiety; Depression

Keywords

poverty; discrimination

Outcome Measures

Primary Outcomes (1)

• HPA Reactivity Profile

  Changes in levels of salivary cortisol across a 90 minute Trier Social Stress Test protocol

  Pre-post (3 months) and Pre-follow-up (6 and 12 months)

Secondary Outcomes (2)

• Internalizing symptoms

  Pre-follow-up (6 and 12 months)

• Coping Skills Acquisition

  pre-post (3 months) and Pre-follow-up (6 and 12 months)

Study Arms (2)

BaSICS Intervention

EXPERIMENTAL

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 3-month and 12-month follow-up assessments.

Behavioral: Building a Strong Identity and Coping Skills

Comparison

NO INTERVENTION

These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 3-month and 12-month follow-up assessments. No intervention.

Interventions

Building a Strong Identity and Coping Skills BEHAVIORAL

Psychoeducational program to teach children coping skills, healthy identity development, and collective social action.

Also known as: BaSICS

BaSICS Intervention

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child age 11 or 12 at intake
• Family income at or below 200% Federal Poverty Level
• Child speaks English
• Parent speaks English or Spanish

You may not qualify if:

• Intellectual disability
• Autism diagnosis
• Exceeds clinical cutoff for anxiety or depressive disorder

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Hamilton Health Center

Harrisburg, Pennsylvania, 17104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Martha E Wadsworth, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 6, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)