RECRUITING

The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care

Quick Facts

Study Start:2025-03-20

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07020572

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
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 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.	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.

Inclusion Criteria

Exclusion Criteria

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
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.

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.

Contacts and Locations

Study Contact

Molly F Davis, PhD

CONTACT

2674250721

davismf@chop.edu

Jami F. Young, PhD

CONTACT

2674251328

youngjf@chop.edu

Principal Investigator

Molly F Davis, PhD

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Molly F Davis, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-20

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-03-20

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Depressive Symptoms