The PATHway Study: Primary Care Based Depression Prevention in Adolescents

Depression Clinical Trial

— PATHway  

Official title:

Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203198
• Other study ID #: CHAIRb 20080601
• Secondary ID: 1R01MH124723-01
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: University of Illinois at Chicago
• Contact: Benjamin W Van Voorhees, MD, MPH
• Phone: 312-996-8352
• Email: bvanvoor[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

With more than 13% of adolescents diagnosed with depressive disorders each year, prevention of depressive disorders has become a key priority for the National Institute of Mental Health (NIMH). Unfortunately, the investigators have no widely available interventions to reduce morbidity and mortality (e.g. public health impact). To address this need, the investigators developed a multi-health system "collaboratory" to develop and evaluate the primary care based technology "behavioral vaccine," Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT) (14 adolescent, 5 parent modules). Using this health-system collaboratory model, the full CATCH-IT program (all modules), demonstrated evidence of efficacy in prevention of depressive episodes in phase-three clinical trials in the United States and China. However, like many "package" interventions, CATCH-IT became larger and more complex across efficacy trials. Thus, adolescents were less willing to complete all 14 modules, suggesting adolescent dose "tolerability" issues (e.g., satisfaction, acceptability and resource use, "time as cost"). Similarly, primary care practices have "scalability" challenges (acceptability, feasibility, resource use, cost), resulting in declining REACH (percent of at-risk youth who complete intervention). To prepare for implementation studies and dissemination, the investigators need to address adolescent tolerability and practice/health system scalability, while preserving efficacy. Multiphase Optimization Strategy (MOST) uses a systematic analytic approach and a factorial randomized clinical trial design to address efficacy, tolerability, and scalability, simultaneously. The investigators will use a MOST approach to optimize CATCH-IT for the prevention of depression (indicated prevention, i.e., elevated symptoms of depression) in practices and health systems representative of US geography and population. The theoretically grounded components of CATCH-IT selected for study and optimization include: behavioral activation, cognitive-behavioral therapy, interpersonal psychotherapy, and parent program. The investigators will use a 4-factor (2x2x2x2) fully crossed factorial design with N=16 cells (25 per cell, 15% dropout) to evaluate the contribution of each component. The investigators propose to randomize N=400 adolescents from multiple sites: Advocate-Aurora Health Care (n=200); Lurie Children's Hospital (n=70); NorthShore University HealthSystem (n=70); University of Chicago Comer Hospital (n=25); University of Texas (n=20); University of Illinois College of Medicine Peoria (n=15). The at-risk youth will be high school students 13 through 18 years old, not currently experiencing a mood disorder, but with subsyndromal symptoms of depression (moderate to high risk). Using the efficient factorial design, the investigators can assess the contribution to prevention efficacy of each component. Thus, the MOST study design will enable us to eliminate non-contributing components while preserving efficacy and to optimize CATCH-IT by strengthening tolerability and scalability by reducing "resource use." By reducing resource use, the investigators anticipate satisfaction and acceptability will also increase, preparing the way for an implementation trial and eventual US Preventive Services Task Force endorsement to support dissemination. Thus, the primary question is whether one component, or perhaps two, can demonstrate an equivalent effect to combinations of other components in terms of efficacy, whilst also demonstrating superior adolescent/family tolerability scalability over a 12-month follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Adolescents ages 13 through 18 years, and

• Adolescents must be experiencing an elevated level of depressive symptoms (PHQ-9 = 5-18), and

• Adolescents will be included if they have had past depressive episode/s, but not if they are in a current depressive episode.

Exclusion Criteria:

1. Outside age range:

1. 12 or younger

2. 19 or older

2. Adolescent is a non-English speaker/reader

3. On the PHQ-9 screening, depression symptom level is:

1. PHQ-9 = 4 or lower

2. PHQ-9 =19 or higher

4. As assessed by the MINI Kid, a current depressive episode

5. As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder.

6. Currently using medication therapy for depression, anxiety, or other internalizing disorders.

7. Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen)

8. Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen)

9. Any past psychiatric hospitalizations

10. Any past suicide attempt or incident of self-harm with moderate or greater lethality

11. Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT)

12. Current suicidal thoughts

1. Eligibility will be determined on a case-by-case basis during the baseline PhQ-9 and MINI Kid assessment process and after a consultation with a licensed mental health clinician has taken place. If adolescent report suicidal ideation on the baseline PhQ-9, and found ineligible, the MINI Kid assessment may not be required.

2. Adolescents with current (within the past 6 months), active suicidal feelings will be excluded.

3. Adolescents with passive thoughts of death or suicide but report to the mental health clinician that they would never act on these thoughts may be admitted, depending on the severity of the risk.

4. Adolescents with past (greater than 6 months ago) ideation who are determined to be low risk will be admitted into the study if there has never been an attempt of moderate or greater lethality.

13. Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities

14. Not willing to comply with the study protocol

15. Did not complete phone assessment with MINI Kid by BCC

16. Not affiliated with any of the sites listed in Appendix A.

17. Parent/guardian does not speak English or Spanish

18. Parent/guardian has a cognitive or intellectual impairment

19. Participant Declined/Changed Mind/Uninterested in participating

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Mental Disorder in Adolescence
• Mental Disorders

Intervention

Behavioral:
• Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
Self-directed, technology-based, depression prevention program for adolescents and parents.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	UI Health	Chicago	Illinois
United States	University of Chicago Comer Children's Hospital	Chicago	Illinois
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Northshore University HealthSystem	Glenview	Illinois
United States	Advocate Aurora Health	Park Ridge	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Advocate Health Care, Ann & Robert H Lurie Children's Hospital of Chicago, National Institute of Mental Health (NIMH), NorthShore University HealthSystem, University of Chicago, Wellesley College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Systolic and diastolic blood pressure	Measured in millimeters of mercury.	At baseline
Primary	Height	Measure by standard medical office practice measure, without shoes, in centimeters.	At baseline
Primary	Weight	Measured in kilograms by standard medical office scale, fully clothed participant.	At baseline
Primary	Body Mass Index	Calculated by measuring height (centimeters) and weight (kilogram) to calculate kg/meters squared (BMI, Body Mass Index).	At baseline
Secondary	Moderation of COVID-19-related behaviors and consequences	The investigators will examine COVID-19-related behaviors and consequences (e.g. social distancing, sheltering-in-place, family illness and death) that that may be moderators of study outcomes using the Holliston at-Home Questionnaire (a 40-item, adolescent self-report, 5-point Likert scale, 0-150 score range, higher score indicates greater behaviors and consequences).	Baseline through 12 months
Secondary	Moderation of COVID-19-related social determinants of health	The investigators will examine COVID-19-related social determinants of health (e.g. food insecurity, internet access, unemployment) that may be moderators of study outcomes using the Holliston at-Home Questionnaire (a 40-item, adolescent self-report, 5-point Likert scale, 0-150 score range, higher score indicates greater number of social determinants).	Baseline through 12 months