Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11+
SponsorPenn State University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children ages 11-14 at intake
Family income at or below 200% federal poverty level
Child speaks English
Parent speaks English or Spanish
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Building a Strong Identity and Coping Skills
BehavioralPsychoeducational program to teach children coping skills, healthy identity development, and collective social action
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: BaSICS InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety
Changes in the number of anxiety problems that children report. Anxiety problems will be measured using the Screen for Child Anxiety Related Disorders (SCARED), Child Behavior Checklist (CBCL), and Youth Self Report (YSR).
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)2
Depression
Changes in the number of depressive symptoms that children report. Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9A), CBCL, and YSR.
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)3
Suicide Risk Markers
Changes in the number of suicide risk markers that children report. Suicide risk markers will be measured using the Child Trauma Screen (CTS) and Mini Kid.
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)Secondary outcomes
1
Engagement Coping Skills Acquisition
Changes in the number of coping skills that children can report. Engagement Coping Skills Acquisition will be assessed with the Responses to Stress Questionnaire (RSQ), Children's Sadness Management Scale (CSMS) and Coping Skills Scale (CSS).
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)2
HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test (TSST) protocol
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)3
Collaborative Coping
Changes in the number of collaborative coping skills that children report. Collaborative Coping will be assessed with the Collaborative Coping Discussion, Youth Civic and Character Measure (YCCM), and Social Skills Improvement System (SSIS).
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)4
Sociocultural Identity Development
Changes in the sociocultural identity beliefs that children report. Sociocultural identity beliefs will be assessed with the Child and Adolescent Social Support (CASS), Early Identity Exploration Scale (EIES), and Multigroup Ethnic Identity Measure (MEIM).
Time frame
Pre-post (3 months) and Pre-follow up (6 and 12 months)Sponsors and contacts
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Source ClinicalTrials.gov