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Behavioral Intervention

Interpersonal Psychotherapy for Depression (SAM Trial)

N/A
Waitlist Available
Led By Jami Young, PhD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescents in 9th or 10th grade between the ages of 14 and 17
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 month, 3 month, 9 month, 15 month
Awards & highlights

SAM Trial Summary

This trial will examine the effects of an evidence-based depression prevention program delivered via telehealth, as compared to usual care, on social processes and emotional and school outcomes. It will also assess the costs, cost-effectiveness, acceptability, feasibility, fidelity, and sustainability of the intervention.

Who is the study for?
This trial is for 9th or 10th graders, ages 14-17, who show signs of depression. They must score at least a 16 on the CES-D and have some symptoms of depression according to K-SADS-PL. Participants need internet access and a device for telehealth sessions, speak English (with parents speaking English or Spanish), and give consent.Check my eligibility
What is being tested?
The study tests if Interpersonal Psychotherapy - Adolescent Skills Training (IPT-AST) delivered via telehealth can help prevent depression better than standard school services. It looks at how it affects social behavior, emotions, and school performance while evaluating its cost-effectiveness and practicality in schools.See study design
What are the potential side effects?
Since IPT-AST is a form of psychotherapy focusing on improving interpersonal skills to reduce depressive symptoms, there are generally no physical side effects like with medication; however emotional discomfort may arise as part of the therapeutic process.

SAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a 9th or 10th grader aged between 14 and 17.

SAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 month, 3 month, 9 month, 15 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 month, 3 month, 9 month, 15 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in academic grades
Change in school attendance
Depression symptoms
+2 more
Secondary outcome measures
Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
Acceptability - counselors: A self-report measure, Counselor Feedback Form
Anxiety symptoms
+7 more
Other outcome measures
Parent-child conflict
Perspective-taking
Quality of relationships: Inventory of Parent and Peer Attachment (IPPA-45)
+1 more

SAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Interpersonal Psychotherapy-Adolescent Skills TrainingExperimental Treatment1 Intervention
Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) is an indicated group depression prevention program. In IPT-AST, adolescents learn communication (e.g., using I statements, striking while the iron is cold) and interpersonal problem-solving strategies and apply these strategies to their relationships to decrease conflict, increase social support, and improve overall social functioning. IPT-AST consists of 1 or 2 individual pre-group sessions, 1 mid-group session, 8 weekly group sessions, and up to 6 individual booster sessions. Parents are invited to attend the mid-group session so the adolescents can apply the interpersonal strategies in a conversation with a parent. The purpose of the booster sessions is to monitor symptoms and apply the interpersonal strategies to current stressors. These sessions are designed to help solidify the interpersonal skills and address current problems before they result in a worsening of symptoms.
Group II: Services as Usual (SAU)Active Control1 Intervention
Investigators anticipate that counselors in SAU will see youth in the study for brief, periodic sessions and/or will refer youth for treatment in the community. Counselors will be permitted to see the adolescents as often as they would like throughout the course of the study (up to 15-months post-baseline). Investigators will ask counselors to complete a form each time they see a teen, noting the length of the session, whether the session was scheduled or not, and the topics discussed.

Find a Location

Who is running the clinical trial?

Institute of Education SciencesFED
7 Previous Clinical Trials
2,370 Total Patients Enrolled
1 Trials studying Depression
615 Patients Enrolled for Depression
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,581,061 Total Patients Enrolled
16 Trials studying Depression
2,126 Patients Enrolled for Depression
Jami Young, PhDPrincipal InvestigatorCHOP, University of Pennsylvania Perelman School of Medicine

Media Library

Interpersonal Psychotherapy - Adolescent Skills Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04109716 — N/A
Depression Research Study Groups: Interpersonal Psychotherapy-Adolescent Skills Training, Services as Usual (SAU)
Depression Clinical Trial 2023: Interpersonal Psychotherapy - Adolescent Skills Training Highlights & Side Effects. Trial Name: NCT04109716 — N/A
Interpersonal Psychotherapy - Adolescent Skills Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04109716 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results does this experiment seek to yield?

"The primary endpoint of the trial will be Impairment and it will be measured at Screen, baseline, 2 month, 3 month, 9 month and 15 months. Additionally, Acceptability - counselors (self-report measure), Counselor Feedback Form (self-report measure) Fidelity to intervention (IPT-AST Fidelity Checklist completed by counsellors/consultants), Number of disciplinary incidents (examined through school records from baseline to 15 months assessment) are secondary objectives that need to be assessed."

Answered by AI

How many participants are enrolled in the current experiment?

"Affirmative. According to clinicaltrials.gov, this experiment started advertising for participants on August 15th 2019 and was most recently updated on March 11th 2022. It is seeking 240 individuals from a single site."

Answered by AI

Does the age threshold for this research extend beyond fifty-five years?

"Within the bounds of this trial's enrolment criteria, prospective participants must be at least 14 years old and no older than 75."

Answered by AI

What criteria must prospective participants meet to be considered eligible for this research study?

"This depression-related study requires 240 volunteers aged 14 to 75, who have a CES-D score of 16 or higher and at least 2 symptoms on the K-SADS-PL. Additionally, adolescent participants need to be between 9th and 10th grade."

Answered by AI

Is recruitment still available for this experiment?

"This clinical trial is still recruiting patients, as indicated on the official website. It was first advertised in August of 2019 and recently updated in March 2022."

Answered by AI

Who else is applying?

What site did they apply to?
Children's Hopsital of Philadelphia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
School Adolescent Mood Project: Efficacy of IPT-AST in Schools
2019. "School Adolescent Mood Project: Efficacy of IPT-AST in Schools". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04109716.
All > Depression New York
~16 spots leftby Sep 2024
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