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

Primary Purpose

Chronic Stress, Anxiety, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Building a Strong Identity and Coping Skills
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stress focused on measuring Poverty, Discrimination, Stress, Coping

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Pennsylvania Psychiatric Institute
  • Penn State Health Medical Group - Psychiatry and Behavioral Health
  • Penns Valley Area School District
  • Dr. Edwin L. Herr Clinic
  • Penn State Psychological Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

BaSICS Intervention

Control EMA

Control

Arm Description

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. During their enrollment in the study, children will also complete EMA assessments.

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. Children will also complete EMA assessments. No 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. Children will not complete EMA assessments. No intervention.

Outcomes

Primary Outcome Measures

Internalizing symptoms (Anxiety and Depression)
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Internalizing symptoms (Anxiety and Depression)
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Internalizing symptoms (Anxiety and Depression)
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist

Secondary Outcome Measures

Coping Skills Acquisition
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Coping Skills Acquisition
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Coping Skills Acquisition
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol

Full Information

First Posted
February 9, 2023
Last Updated
March 28, 2023
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT05789446
Brief Title
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
Official Title
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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), control Ecological Momentary Assessment (EMA) (5), or control (5) 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 internalizing symptoms, changes in coping mechanism, and HPA reactivity profiles

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stress, Anxiety, Depression
Keywords
Poverty, Discrimination, Stress, Coping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BaSICS Intervention
Arm Type
Experimental
Arm Description
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. During their enrollment in the study, children will also complete EMA assessments.
Arm Title
Control EMA
Arm Type
No Intervention
Arm Description
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. Children will also complete EMA assessments. No intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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. Children will not complete EMA assessments. No intervention.
Intervention Type
Behavioral
Intervention Name(s)
Building a Strong Identity and Coping Skills
Other Intervention Name(s)
BaSICS
Intervention Description
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
Primary Outcome Measure Information:
Title
Internalizing symptoms (Anxiety and Depression)
Description
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Time Frame
Pre-post (3 months)
Title
Internalizing symptoms (Anxiety and Depression)
Description
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Time Frame
Pre-follow up (6 months)
Title
Internalizing symptoms (Anxiety and Depression)
Description
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Time Frame
Pre-follow up (12 months)
Secondary Outcome Measure Information:
Title
Coping Skills Acquisition
Description
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Time Frame
Pre-post (3 months)
Title
Coping Skills Acquisition
Description
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Time Frame
Pre-follow up (6 months)
Title
Coping Skills Acquisition
Description
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Time Frame
Pre-follow up (12 months)
Title
HPA Reactivity Profile
Description
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
Time Frame
Pre-post (3 months)
Title
HPA Reactivity Profile
Description
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
Time Frame
Pre-follow up (6 months)
Title
HPA Reactivity Profile
Description
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
Time Frame
Pre-follow up (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martha E Wadsworth, PhD
Phone
814-865-2878
Email
mew27@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dara Babinksi, PhD
Email
dbabinski@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha E Wadsworth, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania Psychiatric Institute
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Lagman, MD
Email
jlagman@pennstatehealth.psu.edu
Facility Name
Penn State Health Medical Group - Psychiatry and Behavioral Health
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dara Babinski, PhD
Email
dbabinski@pennstatehealth.psu.edu
Facility Name
Penns Valley Area School District
City
Spring Mills
State/Province
Pennsylvania
ZIP/Postal Code
16875
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurt Nyquist
Email
knyquist@pennsvalley.org
Facility Name
Dr. Edwin L. Herr Clinic
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Nadermann, PhD
Email
kmc452@psu.edu
Facility Name
Penn State Psychological Clinic
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estee Hausman, PhD
Email
exh471@psu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data produced in the course of the project will be preserved and shared after de-identification. Item level spreadsheet data for all variables will be shared openly once cleaned. Data will be deposited into the National Institute of Mental Health Data Archive.
IPD Sharing Time Frame
Data will become available after de-identification and cleaning.

Learn more about this trial

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

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