Online System for Identifying and Addressing Teen Depression in Primary Care

NCT04489485 | Unknown DMC

• 2 other identifiers: R44MH1167511R44MH116751-01A1
• Study Type: observational
• Target: 580
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Dysthymia; Depressive Symptoms

Keywords

depression

Outcome Measures

Primary Outcomes (2)

• Change in Short Moods and Feelings Questionnaire

  A brief screen of depressed mood completed by teen, 0-26 with 26 worst

  Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months

• Change in Short Moods and Feelings Questionnaire- Parent version

  A brief screen of depressed mood completed by parent, 0-26 with 26 worst

  Day 1 well visit, day 1 + 3 months, day 1 + 6 months, and day 1 + 11.5 months

Secondary Outcomes (3)

• Change in Self report of treatment access

  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

• Patient Health Questionnaire-9 (PHQ-9)

  Entire study period of up to 3 years

• Ask Suicide Screening Questions (ASSQ)

  Entire study period of up to 3 years

Study Arms (5)

Primary Care Providers (PCP)

20 PCP who provide well child care to teens 12-18. After randomization, 10 PCPs in the enhanced care group will use the Teen Depression Module for care.

Behavioral: Teen Depression Module used for care

Standard care teens

All teens coming for routine well child care to the control group PCPs will have routine depression screening and Youth Health Questionnaire without goals to inform treatment as usual. They will be offered a goals text messaging conversation. Suicide screening will be at the discretion of the PCP.

Enhanced care teens

All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, as well as Youth Health Questionnaire with goals and then they will receive treatment guided by the Teen Depression Module and offered a depression text messaging conversation. Suicide screening will be conducted.

Behavioral: Teen Depression Module used for care

Standard care- caregivers

All caregivers of teens \<18 years old coming for routine well child care to the control group PCPs will complete a Pediatric Symptom Checklist and Short Moods and Feelings Questionnaire, plus a Youth Health Questionnaire- Parent version to inform treatment as usual. If the internalizing subscale is positive the caregiver will also complete the Short Moods and Feelings Questionnaire and 3, 6 and 11.5 month follow up report of Intervention received (Parent Intervention Questionnaire)

Enhanced care- caregivers

All caregivers of teens \<18 years old coming for routine well child care to the enhanced group PCPs will complete a Pediatric Symptom Checklist plus a Youth Health Questionnaire- Parent version to inform treatment as usual. If the internalizing subscale is positive the caregiver will also complete the Short Moods and Feelings Questionnaire and 3, 6 and 11.5 month follow up report of Intervention received (Parent Intervention Questionnaire)

Interventions

Teen Depression Module used for care BEHAVIORAL

All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, and treatment using the Teen Depression Module and offered a depression chabot. Suicide screening will be conducted.

Enhanced care teens; Primary Care Providers (PCP)

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• English speaking teens
• English speaking caregivers

You may not qualify if:

• Non English speaking teens
• Non English speaking caregivers

Sponsors & Collaborators

• Total Child Health, Inc.: lead
• National Institute of Mental Health (NIMH): collaborator
• Foresight Logic: collaborator

Study Sites (1)

Total Child Health

Baltimore, Maryland, 21210, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Dysthymic Disorder; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Barbara J Howard, MD

  Total Child Health

  PRINCIPAL INVESTIGATOR

• Raymond A Sturner, MD

  Center for Promotion of Child Development

  PRINCIPAL INVESTIGATOR

• Marianne Wamboldt, MD

  U Colorado Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Howard, MD

CONTACT

4436189104; bhoward@chadis.com

Kerry A Bet, MPH

CONTACT

8884242347; kbet@chadis.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Total Child Health

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: July 28, 2020
• Study Start: February 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after results are published.
• Access Criteria: Qualified medical or mental health researchers.

Locations

US (1)