PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents

NCT04290754 | Active Not Recruiting DMC

• 3 other identifiers: CHAIRb 19081501IHS-2017C3-9333094637
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 1

Brief Summary

PATH (Promoting AdolescenT Health) 2 Purpose is a two-arm comparative effectiveness research trial to that will evaluate the ability of the interventions, Competent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) and Teens Achieving Mastery over Stress (TEAMS), to intervene early to prevent depressive illness and potentially other common mental health disorders. Using cluster randomization, 564 participants eligible for the study will be offered one of two different depression prevention programs in multiple sites in Chicagoland, Rockford, Illinois; Dixon, Illinois; and Louisville, Kentucky. In response to the Coronavirus Disease 2019 (COVID-19) pandemic, we will employ a public health media campaign to recruit a second cohort of 100 adolescents state-wide in Illinois, Kentucky, and Massachusetts individually randomized to either intervention. The study will also assess teens', parents' and providers' experiences with each intervention approach. Finally, we will examine the impact of the COVID-19 pandemic on adolescents at-risk for depression who are enrolled in our study.

Conditions

Depression

Keywords

Adolescents; Depression; Internet intervention; Cognitive-Behavioral Therapy; Prevention; Group Therapy

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, TEAMS group activities, including travel time to and from TEAMS groups. 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 18 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 18 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 an 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 18 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 18 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 18 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 18 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 18 months

• Relationships (Life Events)

  University of California at Los Angeles (UCLA) Life Events Scale (19-items, self-report) administered to adolescents only.

  Baseline through 18 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 18 months

• Organizational Readiness to Change Assessment

  Organizational Readiness to Change Assessment (ORCA, 18 questions, 4 items per question, self-report, 5-point Likert scale, 18-90 score range, higher score indicates higher organizational readiness, component of cultural acceptability to practice, community center, healthcare organizations, health systems)

  Baseline

• Intervention Sustainability

  Program Sustainability Assessment Tool (PSAT, 8 questions, self-report 5 items per question, 7-point Likert scale, 8-56 score range, higher score indicates higher capacity for program sustainability, component of cultural acceptability to practice, community center, healthcare organizations, health systems)

  end of study, 30 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)

  end of study, 30 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)

  end of study, 30 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)

  Baseline through 18 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 18 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 18 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 18 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 18 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 18 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 18 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 18 months

• Relationships-Family

  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 18 months

• Blood Pressure

  Measured in millimeters of mercury

  Baseline and 18 months

• Body Mass Index

  Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index)

  Baseline and 18 months

• Weight

  Measured in kilograms by standard medical office scale, fully clothed participant

  Baseline and 18 months

• Height

  Measure by standard medical office practice measure, without shoes, in centimeters

  Baseline and 18 months

• Recruiting model and comparative effectiveness outcomes

  With the addition of a second cohort to be recruited through a public health media campaign, we will compare results between groups in each arm, and between the two recruitment models. We will compare implementation and clinical outcomes in the same trial arm, but also across the two recruiting methods.

  Baseline through 18 months

Secondary Outcomes (2)

• Implementation themes

  End of study, 30 months

• Moderation of Covid-19 factors on comparative effectiveness outcomes

  Baseline through 18 months

Study Arms (2)

CATCH-IT

EXPERIMENTAL

Competent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious.

Behavioral: CATCH-IT

TEAMS

ACTIVE COMPARATOR

Teens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive-behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.

Behavioral: TEAMS

Interventions

CATCH-IT BEHAVIORAL

Competent Adulthood Transition with Cognitive-behavioral \& Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious.

CATCH-IT

TEAMS BEHAVIORAL

Teens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.

Also known as: Prevention of Depression (POD)

TEAMS

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents ages 13 through 19 years, and
• Adolescent must be experiencing an elevated level of depressive symptoms (Patient Health Questionnaire-9 Score = 5-18), and
• Adolescent will be included if they have a past, but not current history of depression.

You may not qualify if:

• Outside age range
• A current diagnosis of Major Depression
• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of: schizophrenia, bipolar affective disorder, extreme current drug or alcohol abuse.
• Currently using medication therapy for depression, anxiety, or other internalizing disorders for less than 3 months.
• Currently engaged in individual treatment for a mood disorder
• Currently engaged in a cognitive-behavioral group or therapy
• Any past psychiatric hospitalizations
• Any past self-harm attempt with moderate or greater lethality
• Current suicidal thoughts
• Not willing to comply with the study protocol
• Not willing to participate in the TEAMS groups
• Not willing to be audio recorded during TEAMS groups (only for TEAMS clinics)
• Unable to complete the PHQ-9 screening due to cognitive or intellectual impairment
• Did not complete phone assessment with MINI Kid
• Parent/guardian has a cognitive or intellectual impairment.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Illinois College of Medicine Rockford: collaborator
• Wake Forest University Health Sciences: collaborator
• Katherine Shaw Bethea Hospital: collaborator
• University of Louisville: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Brown University: collaborator
• Mile Square Health Center: collaborator

Study Sites (1)

UI Health

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Knepper AK, Feinstein RT, Sanchez-Flack J, Fitzgibbon M, Lefaiver C, McHugh A, Gladstone TRG, Van Voorhees BW. Primary care-based screening and recruitment for an adolescent depression prevention trial: Contextual considerations during a youth mental health crisis. Implement Res Pract. 2024 Apr 22;5:26334895241246203. doi: 10.1177/26334895241246203. eCollection 2024 Jan-Dec.

  PMID: 38655380 DERIVED

Related Links

• Path2Purpose Website

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Benjamin W Van Voorhees, MD, MPH

  University of Illinois at Chicago, School of Medicine

  PRINCIPAL INVESTIGATOR

• Tracy RG Gladstone, PhD

  Wellesley College, Wellesley Centers for Women

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Cluster randomization of clinic sites
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Head of Department of Pediatrics, Physician-in-Chief of Childrens Hospital University of Illinois

Model Details: Comparative Effectiveness Study

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: March 2, 2020
• Study Start: January 1, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)