Depression Clinical Trial
— PATHwayOfficial title:
Primary Care Based Depression Prevention in Adolescents: Intervention Optimization in Preparation for Implementation Study
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.
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 |
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 |
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 |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |