Brief Summary

Prevention of depressive disorders has become a key priority for the NIMH, but the investigators have no widely available public health strategy to reduce morbidity and mortality. To address this need, the investigators developed and evaluated the primary care based-technology "behavioral vaccine," Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT). The investigators will engage N=4 health systems representative of the United States health care system, and conduct a factorial design study to optimize the intervention in preparation for an implementation study and eventual dissemination.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P75+ for not_applicable depression

Timeline

6mo left

Started Feb 2022

Longer than P75 for not_applicable depression

Geographic Reach

1 country

6 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

Study Progress90%

Feb 2022Oct 2026

First Submitted

Initial submission to the registry

January 10, 2022

Completed

14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed

8 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 10, 2022

Last Update Submit

January 6, 2026

Conditions

Depression Mental Disorder in Adolescence

Keywords

Adolescents DepressionInternet interventionCognitive-Behavioral TherapyPreventionMOST design

Outcome Measures

Primary Outcomes (27)

Time
Time will be measured to nearest minute for all intervention related activities including initial screening, engagement phone calls, use of CATCH-IT. Time will be measured from adolescent, family, practice, community center, healthcare organization, health system perspective. For time that cannot be directly measured by study staff, the investigators will sample direct observation or questionnaires to capture time required for health system related activities such as screening and engagement.
Baseline through 12 months
Cultural acceptability adolescent and family
Cultural acceptability for each stakeholder using appropriate, validated instruments. Adolescent and family: Usefulness, Satisfaction, and Ease Questionnaire (USE, 30 items, self-report, 7-point Likert scale, 30-210 score range, higher score indicates more acceptable). An example statement is: "I would recommend this to a friend."
Baseline through 12 months
Cost
Costs will be measured for all stakeholders. For practice, community center, healthcare organizations, health systems, cost will be measured to nearest dollar by converting time measures into employment related costs based on mean wages and benefits for staff at that occupational level. Adolescent and family costs will be measured by converting time into mean hourly wages and benefits for adolescent and family members involved in the project (based on mean wage for age and occupation).
Baseline through 12 months
Depressive Symptoms
Patient Health Questionnaire-Adolescent (PHQ-A, 9 items plus 4 follow-up items, self-report, 3-point Likert scale, 0-27 score range, higher score indicates more depression symptoms/severity).
Baseline through 12 months
Depressive and mental disorder episodes
Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid, self-report). This is a structured psychiatric interview administered by a trained staff member which uses stem questions and follow-ups to determine the presence of symptoms and date of onset. The staff member then determines if and when the symptoms developed an episode is present. Measure is either episode present or not and date of onset.
Baseline through 12 months
Stress symptoms
Center for Epidemiological Studies-Depression Scale (CES-D, 20 items, self-report, measured in frequency, 0,"not at all" to 3, "nearly every day in last week, 0-60 score range, higher score indicates more depressed).
Baseline through 12 months
Resiliency
Resiliency will be measured across multiple domains. To assess resiliency in terms of coping skills, the Connor-Davidson Resilience Scale (CD-RISC, 10 items, self-report, 4 levels of response, 0-40 score range, higher score indicates better coping skills).
Baseline through 12 months
Function
Social Adjustment Scale Self-Report (SAS-SR, 23-items, self-report, 5-point Likert scale, 23-115 score range, higher score indicates higher levels of social adjustment) administered to adolescents only.
Baseline through 12 months
Relationships (Life Events)
University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only.
Baseline through 12 months
Socio-cultural Relevance
The Socio-Cultural Relevance Scale (10-item and 14-item versions, self-report, 5-point Likert scale, 10-40 or 14-56 score ranges, higher score indicates greater socio-cultural relevance) will assess perceived change and satisfaction with the intervention, component of cultural acceptability to adolescent)
Baseline through 12 months
Acceptability of Intervention
Acceptability of Intervention Measure (AIM, 1 question with 4 items, self-report, 5-point Likert scale, 1-5 score range, higher score indicates greater acceptability of intervention, to be completed by all staff and leadership, repeatedly, component of cultural acceptability to practice, community center, healthcare organizations, health systems).
Start to end of recruitment, 32 months
Feasibility of Intervention
Feasibility of Intervention Measure (FIM, 1 question with 4 items, self-report, 5-point Likert scale, 1-5 score range, higher score indicates greater feasibility of intervention, to be completed by all staff and leadership, repeatedly, component of cultural acceptability to practice, community center, healthcare organizations, health systems).
Start to end of recruitment, 32 months
Intervention Appropriateness
Intervention Appropriateness Measure (IAM, 1 question with 4 items, self-report, 5-point Likert scale, 1-5 score range, higher score indicates greater appropriateness of intervention, to be completed by all staff and leadership, repeatedly, component of cultural acceptability to practice, community center, healthcare organizations, health systems).
Start to end of recruitment, 32 months
Externalizing Behavior Symptoms
Disruptive Behavior Disorders Rating Scale-Adolescent (DBD-A, 41-items, self-report, 4-point Likert scale, 0-123 score range, higher score indicates greater externalizing symptoms).
Baseline through 12 months
Anxiety Symptoms
Screen for Child Anxiety Related Disorders (SCARED, 41-items, self-report, 3-point Likert scale, 0-82 score range, higher score indicates greater anxiety symptoms).
Baseline through 12 months
Substance Abuse Symptoms
Car, Relax, Alone, Forget, Friends, Trouble substance use assessment (CRAFFT, 6 items, self-report, 2-point scale, 0-6 score range, higher score indicates greater substance abuse symptoms).
Baseline through 12 months
Post Traumatic Stress Disorder Symptoms
Child Post Traumatic Symptoms Disorder Scale (24-items, self-report, 4-point Likert scale, 0-72 score range, higher score indicates greater PTSD symptom levels).
Baseline through 12 months
Rumination
Tendency towards rumination will be assessed by the Children's Response Style Scale (CRSS, 10-items, self-report, 5-point Likert scale, 0-50 score range, higher score indicates greater rumination (more repeated negative thinking, less resilient, component of resiliency).
Baseline through 12 months
Dysfunctional Attitudes
The Dysfunctional Attitude Scale (DAS, 9-item, self-report, 7-point Likert scale, 9-63 score range, higher score indicates more dysfunctional attitude, less resiliency, component of resiliency).
Baseline through 12 months
Family Relationships
Child Report of Parental Behavior Inventory (CRPBI, 30-item, self-report, 3-point Likert scale, 0-60 score range, higher scores indicate more positive parent child relationship).
Baseline through 12 months
Cognitive Style
The Children's Cognitive Style Questionnaire (CCSQ, 6-items, self-report, 5-point Likert scale, 0-150 range, higher score indicates greater negativity of cognitive style).
Baseline through 12 months
Self-efficacy
The Trans-Theoretical Model Scale (TTMS, 10-item, self-report, 4-point Likert scale, 0-24 range, higher score indicates higher self-efficacy and intention to reduce depressive symptoms).
Baseline through 12 months
Social Adjustment
The Social Adjustment Scale-Adolescent version (SAS-SR, 23-item, self-report, 5-point Likert scale, 0-115 range, higher score indicates higher level of social dysfunction).
Baseline through 12 months
Systolic and diastolic blood pressure
Measured in millimeters of mercury.
At baseline
Height
Measure by standard medical office practice measure, without shoes, in centimeters.
At baseline
Weight
Measured in kilograms by standard medical office scale, fully clothed participant.
At baseline
Body Mass Index
Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index).
At baseline

Secondary Outcomes (2)

Moderation of COVID-19-related behaviors and consequences
Baseline through 12 months
Moderation of COVID-19-related social determinants of health
Baseline through 12 months

Study Arms (16)

1. No adolescent modules + no parent modules

NO INTERVENTION

No adolescent nor parent modules will be offered to the participant.