RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2029-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05789446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children ages 11-14 at intake
  2. * Family income at or below 200% federal poverty level
  3. * Child speaks English
  4. * Parent speaks English or Spanish
  1. * Intellectual disability
  2. * Autism spectrum disorder
  3. * High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
  4. * Severe depression (score of 19 or more on Patient health questionnaire (PHQ).

Contacts and Locations

Study Contact

Martha E Wadsworth, PhD
CONTACT
814-865-2878
mew27@psu.edu
Dara Babinksi, PhD
CONTACT
dbabinski@pennstatehealth.psu.edu

Principal Investigator

Martha E Wadsworth, PhD
PRINCIPAL_INVESTIGATOR
Penn State University

Study Locations (Sites)

Pennsylvania Psychiatric Institute
Harrisburg, Pennsylvania, 17110
United States
Penn State Health Medical Group - Psychiatry and Behavioral Health
Hershey, Pennsylvania, 17033
United States
Penns Valley Area School District
Spring Mills, Pennsylvania, 16875
United States
Dr. Edwin L. Herr Clinic
State College, Pennsylvania, 16802
United States
Penn State Psychological Clinic
State College, Pennsylvania, 16802
United States

Collaborators and Investigators

Sponsor: Penn State University

  • Martha E Wadsworth, PhD, PRINCIPAL_INVESTIGATOR, Penn State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2029-05-31

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2029-05-31

Terms related to this study

Keywords Provided by Researchers

  • Poverty
  • Discrimination
  • Stress
  • Coping

Additional Relevant MeSH Terms

  • Chronic Stress
  • Anxiety
  • Depression