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Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)

The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The pilot randomized controlled trial will include adolescents ages 13-17 with subthreshold depression scores on a depression screener, the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M), completed during an annual PC well-visit."
  • "All adolescents randomized to B-IPT-AST will complete a survey measuring acceptability of B-IPT-AST."
  • "Additionally, a subset of adolescents who participate in B-IPT-AST will be invited to participate in an hour-long qualitative interview to give feedback on their experiences with B-IPT-AST to inform any further modifications needed to enhance the program's feasibility and acceptability."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests a program called Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) to help prevent depression in teens in primary care. It looks at whether the program is practical, whether teens accept it, and whether it may help. The study is for teens ages 13 to 17 with certain scores on a depression survey, and their legal guardians.

This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Teens must be 13 to 17 years old and speak English.
  • Teens must score 5 to 10 on the PHQ-9-M, a depression survey for teens, at a routine primary care checkup.
  • A legal guardian must give permission, and the teen must agree to join.
  • Teens must have access to a phone, computer, or other electronic device for study activities.
  • Guardian participants must be the legal guardian of a teen ages 13 to 17 who meets the survey score requirement.
  • Guardian participants must speak English and agree to join.
  • Guardian participants must have access to a phone, computer, or tablet to complete study check-ins from home.

Who can't join

  • Teens cannot join if their checkup survey reports thoughts of death or self-harm in the past week, serious thoughts of suicide in the past month, or any past suicide attempt.
  • Teens cannot join if the survey at the start of the study reports serious thoughts of suicide in the past month.
  • Teens cannot join if a major illness, serious behavior problems, or a disability affecting learning or development could keep them from completing study activities.
  • Teens may not be able to join if records, screening, study visits, or talks with the family suggest the group program is not a good fit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: For Adolescent Participants 1. Adolescents ages 13 to 17 years. 2. Adolescents must be English-speaking. 3. Legal guardian permission (informed consent) and child consent/assent. 4. A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit. 5. Access to a phone, computer, or other electronic device that could be used for study activities For Legal guardian Participants 1. Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit. 2. Consent to participate. 3. English-speaking. 4. Access to a phone, computer, and/or tablet to complete remote evaluations. Exclusion Criteria: Exclusion criteria will be determined based on electronic health record (EHR) review, eligibility screening questions, the baseline evaluation, and any other interactions with the family. 1. Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 "In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?" and/or yes to either of the supplemental questions which ask, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month ("Has there been a time in the past month when you have had serious thoughts about ending your life?") will be excluded. 2. Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures. 3. Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.

Study sites (1)

PA