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

Sponsor

Penn State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05789446

Collaborator

(none)

360

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Stress Anxiety Depression	Behavioral: Building a Strong Identity and Coping Skills	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
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. During their enrollment in the study, children will also complete EMA assessments.	Behavioral: Building a Strong Identity and Coping Skills Psychoeducational program to teach children coping skills, healthy identity development, and collective social action Other Names: BaSICS
No Intervention: Control EMA 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.
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. Children will not complete EMA assessments. No intervention.

Arm

Intervention/Treatment

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

Behavioral: Building a Strong Identity and Coping Skills

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

Other Names:

BaSICS

No Intervention: Control EMA

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.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Internalizing symptoms (Anxiety and Depression) [Pre-post (3 months)]
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Internalizing symptoms (Anxiety and Depression) [Pre-follow up (6 months)]
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist
Internalizing symptoms (Anxiety and Depression) [Pre-follow up (12 months)]
Reduction in total internalizing symptoms (anxiety and depression) reported by parents on the Child Behavior Checklist

Secondary Outcome Measures

Coping Skills Acquisition [Pre-post (3 months)]
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Coping Skills Acquisition [Pre-follow up (6 months)]
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
Coping Skills Acquisition [Pre-follow up (12 months)]
Changes in the number of coping skills that children can report during the Coping Skills interview protocol
HPA Reactivity Profile [Pre-post (3 months)]
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
HPA Reactivity Profile [Pre-follow up (6 months)]
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol
HPA Reactivity Profile [Pre-follow up (12 months)]
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennsylvania Psychiatric Institute	Harrisburg	Pennsylvania	United States	17110
2	Penn State Health Medical Group - Psychiatry and Behavioral Health	Hershey	Pennsylvania	United States	17033
3	Penns Valley Area School District	Spring Mills	Pennsylvania	United States	16875
4	Dr. Edwin L. Herr Clinic	State College	Pennsylvania	United States	16802
5	Penn State Psychological Clinic	State College	Pennsylvania	United States	16802

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator: Martha E Wadsworth, PhD, Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martha E. Wadsworth, Professor of Psychology, Penn State University

ClinicalTrials.gov Identifier:

NCT05789446

Other Study ID Numbers:

PAR-21-132

First Posted:

Mar 29, 2023

Last Update Posted:

Mar 29, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Martha E. Wadsworth, Professor of Psychology, Penn State University

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Mar 29, 2023