Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
Recruiting · NCT07020572 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital of Philadelphia
View the official record on ClinicalTrials.gov →Interventions studied
Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)Services as usual (SAU)
What this trial is about
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.
Who can take part
Age range
13 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- For Adolescent Participants
- Adolescents ages 13 to 17 years.
- Adolescents must be English-speaking.
- Legal guardian permission (informed consent) and child consent/assent.
- A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.
- Access to a phone, computer, or other electronic device that could be used for study activities
- For Legal guardian Participants
- 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.
- Consent to participate.
- English-speaking.
- 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.
- 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.
- Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.
- 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.
Where it is running
1 location listed across 1 US state.
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States