NCT07020572 Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
| NCT ID | NCT07020572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Depressive Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-03-20 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Molly F Davis, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine
Frequently Asked Questions
Who can join the NCT07020572 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Depressive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07020572 currently recruiting?
Yes, NCT07020572 is actively recruiting participants. Contact the research team at davismf@chop.edu for enrollment information.
Where is the NCT07020572 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07020572 clinical trial?
NCT07020572 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Molly F Davis, PhD at Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine. The trial plans to enroll 45 participants.