Adolescent Depression Prevention in Primary Care
Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)
+ Services as usual (SAU)
Behavior
+ Behavioral Symptoms
+ Depression
Prevention Study
Summary
Study start date: March 20, 2025
Actual date on which the first participant was enrolled.This study focuses on preventing depression in teenagers by using a program that can be easily applied in regular doctor visits. Depression is common among teenagers and can lead to negative effects on their lives. Most existing programs that aim to prevent depression take a lot of time and resources. To address this, the study tests a shorter version of a proven therapy called Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) in a primary care setting. The goal is to make it easier for healthcare providers to use this program during routine check-ups for teenagers aged 13-17 who show early signs of depression. In the study, teenagers who have slightly elevated depression scores from a screening questionnaire will be randomly assigned to either receive the B-IPT-AST program or continue with their usual care. The B-IPT-AST program is delivered by trained team members and aims to improve emotional well-being and social interactions. Participants' progress is measured using standardized tools for symptoms like depression and anxiety, as well as interpersonal conflicts. After completing the program, teenagers will fill out a survey to share their thoughts about the program's acceptability. Some will also participate in an interview to provide detailed feedback, which will help improve the program's future use. Researchers will also track how many participants join and stay in the program, as well as attendance at the program sessions, to assess how practical the program is for real-world application.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 13 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Children's Hospital of Philadelphia
Philadelphia, United StatesOpen Children's Hospital of Philadelphia in Google Maps