Clinical trial NCT04489485: Online System for Identifying and Addressing Teen Depression in Primary Care
Official title: Online System for Identifying and Addressing Teen Depression in Primary Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depression
Dysthymia
Depressive Symptoms
Keywords: depression
Lead sponsor: Total Child Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: Foresight Logic
First posted: 2020-07-28
Enrollment: 580
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All teens coming to participating PCPs for well child visits during the study period and their adult caregivers for those under 18

Brief summary: A novel web-based module (Teen Depression Module or TDM)has been created for assisting primary care providers (PCPs) in screening for and addressing and referring teens with depression. This is a cluster randomized Quality Improvement study to determine if use of the TDM that includes collecting information on strengths and goals as part of well child care will improve detection of depression, referral success, and teen's use of alternative helping strategies with resulting improvement in depression symptoms.

Detailed description: Phase II Summary for finalizing and testing the CHADIS Teen Depression Module (TDM) These aims are unchanged except that health screening visits may be in-person or conducted via telehealth.

II-1. Revise programming and training materials: TDM- an addition for primary care screening and care for teen depression as part of the Comprehensive Health and Decision Information System (CHADIS) online questionnaire delivery system with decision support including "motivational interviewing teleprompters", care coordination functionality for referrals, and text chats- will be revised and programmed as needed to adjust for Phase 1 feedback and training materials created.

II-2 Recruit 20 study PCP's, set up care coordination with MH specialists and assess: Investigators will recruit 20 primary care providers (PCPs), assuring representative Medicaid-insured teens, and randomize to intervention or control. Intervention PCPs will identify their local Mental Health (MH) resources to recruit for referrals and use of care coordination functionality. 2 Therapists, 2 PCPs, and 2 Psychiatrists (Psy) using the care coordination will give feedback on functionality, acceptability and likelihood of continued use as well as use of a text messaging robot messaging about referrals after the baseline. Investigators will document current PCP access to MH services.

II-3 Baseline (3 mo.), refine implementation strategies using QI Maintenance of Certification (MOC-4) sessions:

All 20 PCPs will use the Patient Health Questionnaire-9 (PHQ-9) for depression (without follow-up questions) for a baseline, and have implementation issues addressed using Quality Improvement (QI) methods. Data will be collected from teens and parents before in person or telehealth Health Supervision Visits (HSV) using CHADIS. Data on rates of depression screening using CHADIS and billing data will be shared with PCPs as part of Maintenance of Certification Part 4 (MOC-4) sessions for intervention and controls. Teens (\<=480) will be sent a text survey post visit of any strength- or emotion- supporting care received.

II-4 Create child psychiatry version of TDM: Denver team will modify TDM for Psy including care plans.

II-5 Obtain MOC-4 approval for child psychiatry by American Board of Medical Specialties (covering American Board of Psychiatry and Neurology) for Child Psychiatrists for use of the TDM created in II-4 and MOC-4 will be offered to participating Child Psychiatrists.

II-6 Intervention trial: (See Figure) Primary Question 1 (PQ1). For teens PHQ positive, does TDM use result in lower Short Mood \& Feelings Questionnaire (SMFQ) scores at 3-, 6-and 11.5-months vs at start of intervention? Primary Question 2. For teens PHQ positive, does TDM use result in lower teen and parent SMFQ scores at 3-, 6-and 11.5-months vs controls? Secondary Question 1 (SQ1): Of teens PHQ positive, does TDM use result in higher rates of accessing treatment at 3-, 6-and 11.5 months vs controls? Secondary Question 2. Does QI method increase rates of teens screened? Secondary Question 3. Does QI method increase rates of Ask Suicide Questions (ASQ) screening? Design: A cluster randomized trial with a 2-group pretest-posttest design clustered at the PCP level will determine pre-post differences within patients and intervention vs control group differences.

Sample size estimates consider the design effect and use an Intent to Treat model. Sample sizes of 107/PCP in both intervention and control will achieve 89.5% power to detect a difference between group means of \>=2; also sufficient power for Secondary Questions 1-3. Procedure: Both groups: All teens before HSV will do: Visit Priorities, Teen Health \& Goals comprehensive of standard guidelines, and PHQ-9 with follow up to SMFQ, if positive and get health information chats with links to education/advice in their CHADIS Care Portal. All parents will do Visit Priorities and Pediatric Symptom Checklist-17 (PSC) for behavior/mood with follow-up parent SMFQ if the internalizing subscale is positive and can access "handouts" in the parent Care Portal. All PCPs see questionnaire results and earn MOC-4. Intervention group: Teens: will do: goals/strengths/values and ASQ. If PHQ-9 is \>=8 they will get follow-up questions and SMFQ. Teens will get follow-up text message robot dialogues with topic based on if a referral was accepted and other priorities. Chats may encourage strengths and provide resources, goals, mindfulness apps, journaling or depression-Cognitive Behavior Therapy dialogues for PHQ positive teens. Parents: get resources. PCPs: will use TDM results and decision support to detect, educate on depression, and motivate for intervention. They earn MOC.

Follow Up Measures: All teens and parents: get email/text reminders to do questionnaires 3, 6 and 11.5 months (pre next HSV) after initial HSV. Teens positive on initial PHQ-9 in both groups will be paid (and called) to do a repeat PHQ-9 with follow-up about interval treatment and parents will do SMFQ and provide impressions of PCP management and success of any referrals. Rates for Ask Suicide Screening Questions (ASSQ) will be in the intervention group only, as it is not usual care, but any PCP may use it. Evaluation will include: depression screening rates, decision support use, proportions of positive teens referred via care coordination and teen use of resources.

II.7 Analysis of Results of Intervention: Initial: Descriptive analyses. Primary Questions 1\&2: t-tests adjusted for design effect, categorical statistical tests of inference appropriately matched to the underlying distributions of the measures used at T1 and T2, adjusted for design. Secondary Question 2: Chi-Squared Test of Independence on two cross-sectional samples tabulated at T0 and T1. Rates of ASQ use will be assessed for T2-T3. Tests will be applied to 2 cross-sectional samples regardless of treatment arm. Multi-Level Linear Regression models for Primary Questions 1-2 and Logistic Regression models for Secondary Questions 1-3 will assess impact of patient characteristics and item responses, and control for design effect of a cluster-randomized design.

Eligibility criteria: Inclusion Criteria:

* English speaking teens
* English speaking caregivers

Exclusion Criteria:

* Non English speaking teens
* Non English speaking caregivers

Primary outcomes:
measure: Change in Short Moods and Feelings Questionnaire
timeFrame: Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months
measure: Change in Short Moods and Feelings Questionnaire- Parent version
timeFrame: Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months
Secondary outcomes:
measure: Change in Self report of treatment access
timeFrame: Day 1 well visit when there is a positive depression screen, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Entire study period of up to 3 years
measure: Ask Suicide Screening Questions (ASSQ)
timeFrame: Entire study period of up to 3 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Total Child Health
state: Maryland
Study officials:
affiliation: Total Child Health
name: Barbara J Howard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Promotion of Child Development
name: Raymond A Sturner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: U Colorado Medical Center
name: Marianne Wamboldt, MD
role: PRINCIPAL_INVESTIGATOR
References: