- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109716
School Adolescent Mood Project: Efficacy of IPT-AST in Schools (SAM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized clinical trial. Adolescents with elevated depressive symptoms will be identified and randomly assigned to IPT-AST delivered through telehealth by research staff (alone or in collaboration with school support staff) or services as usual (SAU) as delivered by counselors or other student support staff in schools. The research team will use longitudinal data collection with adolescents, parents, and counselors, and will collect data from teachers and school records to achieve study objectives.
Participants will be 240 racially and ethnically diverse students in the 9th and 10th grades between the ages of 14 and 17 with elevated symptoms of depression and their parents. Counselors in local high schools will also be study participants. A subset of counselors, adolescents, and administrators will also participate in a qualitative interview as part of an implementation study.
Adolescent participants will be randomly assigned to IPT-AST, an evidence-based depression prevention program, or SAU which may include supportive counseling and/or referral for services.
Standardized measures for adolescents, parents, and teachers and school records will be used to examine emotional outcomes (e.g., depression and anxiety symptoms, depression diagnoses) and school outcomes (e.g., school engagement, grades). Investigators will utilize standardized measures to assess social processes (e.g., interpersonal conflict, social functioning) that may mediate the effects of the intervention on these emotional and school outcomes. Investigators will also collect data on services received in IPT-AST and SAU, techniques utilized in both conditions, and feasibility, acceptability, fidelity, sustainability, and costs of IPT-AST using session logs, time diaries, standardized measures, leader- and consultant-rated fidelity checklists, and qualitative interviews.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jami F Young, PhD
- Phone Number: 267-425-1328
- Email: youngjf@chop.edu
Study Contact Backup
- Name: Jason Jones, PhD
- Phone Number: 267-425-1326
- Email: jonesjd@chop.edu
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Children's Hopsital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Adolescent Participants
Inclusion Criteria:
- Adolescents in 9th or 10th grade between the ages of 14 and 17
- Adolescent must be English-speaking; parents must be English or Spanish-speaking
- Parental/guardian permission (informed consent) and child assent/consent
- A score of 16 or higher on the CES-D AND at least 2 threshold or subthreshold symptoms on the K-SADS-PL
- Have access to a cellular phone, computer, and/or tablet and have internet access to complete the remote intervention and evaluations
Exclusion Criteria:
- Less than 2 threshold or subthreshold symptoms on the K-SADS-PL
- Significant current active suicidal ideation reported on the K-SADS-PL at the eligibility evaluation or suicide attempt in the past year reported on the K-SADS-PL at the eligibility evaluation
- Significant cognitive or language impairments requiring placement in Special Education as reported by the parent or as evident in the eligibility evaluation
- Youth may be excluded on a case-by-case basis if the eligibility/baseline evaluation suggests that the group program would not be appropriate (for, instance, in the case of significant behavioral problems in the baseline evaluation).
For Parent Participants
Inclusion Criteria:
- Parents of students in 9th or 10th grade between the ages of 14 and 17 at one of the participating schools
- English or Spanish-speaking or limited English proficiency with use of interpreter
- Consent to participate
- Have access to a phone, computer, and/or tablet to complete remote evaluations
Exclusion Criteria:
None
For Parent-Designated Adult Family Member Participants (in cases where parent asks a different family member to complete parent assessments)
Inclusion Criteria:
- 18 years of age or older
- Knows the adolescent well enough to answer questions about him/her
- English or Spanish-speaking or limited English proficiency with use of interpreter
- Consent to participate
- Have access to a phone, computer, and/or tablet to complete remote evaluations
Exclusion Criteria:
None
For Counselor Participants
Inclusion Criteria:
- Counselor at one of the participating high schools
- Consent to participate
- Have access to a phone, computer, and/or tablet to complete remote evaluations
Exclusion Criteria:
None
For Teacher and Administrator Participants
Inclusion Criteria:
- Teacher or administrator at one of the participating high schools
- Consent to participate in the qualitative interview
- Have access to a phone, computer, and/or tablet to complete remote evaluations
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interpersonal Psychotherapy-Adolescent Skills Training
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.
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This is an indicated group depression prevention consisting of 2 individual pre-group sessions, 8 weekly group session, and up to 6 individual booster sessions.
IPT-AST will be delivered predominately through telehealth.
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Active Comparator: Services as Usual (SAU)
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.
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Services as usual is expected to be brief periodic sessions (in person or remote) with the school counselor or services in the community.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression symptoms
Time Frame: Screen, baseline, 2 month, 3 month, 9 month, 15 month
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Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms
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Screen, baseline, 2 month, 3 month, 9 month, 15 month
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Impairment
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
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Change in impairment will be measured by the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment
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Baseline, 2 month, 3 month, 9 month, 15 month
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Onset of depression diagnoses
Time Frame: Eligibility, 15 month
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The onset of diagnoses/change in depression diagnoses during the study period from eligibility to the 15 month assessment will be assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL)
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Eligibility, 15 month
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Change in academic grades
Time Frame: Baseline, 15 month
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Impact of the intervention on school grades will be examined by accessing school records and looking at change in grades from baseline to the 15 month assessment.
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Baseline, 15 month
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Change in school attendance
Time Frame: Baseline, 15 month
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Impact of the intervention on school attendance will be examined by accessing school records and looking at change in attendance from baseline through 15 months.
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Baseline, 15 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Internalizing and externalizing symptoms
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
|
Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens, parents, and teachers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms
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Baseline, 2 month, 3 month, 9 month, 15 month
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Anxiety symptoms
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
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Change in anxiety symptoms will be assessed by the Screen for Child Anxiety Related Disorders (SCARED), a 41-item scale assessing symptoms corresponding to different anxiety disorders; we will examine total scores and the following subscales: panic, GAD, and social anxiety; total scores range from 0-82 (25 or higher indicates clinical range); panic scores range from 0-26 (7 or higher indicates clinical range); generalized anxiety disorder scores range from 0-18 (scores of 9 or higher indicates clinical range); social anxiety scale ranges from 0-14 (scores 8 or higher indicate clinical range)
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Baseline, 2 month, 3 month, 9 month, 15 month
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Number of disciplinary incidents
Time Frame: Baseline, 15 month
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Impact of the intervention on school disciplinary incidents will be examined by accessing school records and looking at number of new disciplinary incidents from baseline to the 15 month assessment
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Baseline, 15 month
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School connectedness
Time Frame: Baseline, 3 month, 9 month, 15 month
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Changes in school connectedness will be measured by the Psychological Sense of School Membership Scale, an 18 item measure of school connectedness; scores range from 18-90; higher scores indicate higher school connectedness
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Baseline, 3 month, 9 month, 15 month
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Emotional and behavioral engagement in learning
Time Frame: Baseline, 3 month, 9 month, 15 month
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The short and long-term impact of the interventions on engagement in learning will be measured by change in the Engagement versus Disaffection with Learning measure, a 20-item scale that assesses emotional and behavioral engagement vs. disengagement in school; total scores range from 20 to 80; behavioral and emotional engagement scores range from 10 to 40, with higher scores indicating greater engagement
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Baseline, 3 month, 9 month, 15 month
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Fidelity to the intervention
Time Frame: Weekly during intervention delivery
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The IPT-AST Fidelity Checklist will be completed by counselors and consultant to rate fidelity to IPT-AST intervention; adherence in each session is rated as a percent adherent; quality of session is also rated as percent; higher scores indicate greater adherence and quality (implementation)
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Weekly during intervention delivery
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Acceptability - counselors: A self-report measure, Counselor Feedback Form
Time Frame: 3 month, 15 month
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A self-report measure, Counselor Feedback Form, will be completed by any counselors who co-lead IPT-AST to assess acceptability of IPT-AST following group (3 month) and booster sessions (15 month) (implementation)
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3 month, 15 month
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Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
Time Frame: 3 month, 15 month
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A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of IPT-AST following group (3 month) and booster sessions (15 month) (implementation)
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3 month, 15 month
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Patterns in qualitative data
Time Frame: 3 month
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Qualitative interviews will be conducted with IPT-AST stakeholders to gather information on implementation of IPT-AST; this is a qualitative interview which will be coded for key themes
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3 month
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Attendance
Time Frame: Weekly during IPT-AST
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Logs will track youth participation in IPT-AST and clinician attendance to IPT-AST consultation as one indicator of feasibility (implementation)
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Weekly during IPT-AST
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perspective-taking
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
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Changes in perspective taking will be measured by the Interpersonal Reactivity Index (IRI), a 7-item perspective-taking scale; scores range from 0-28 with higher scores representing more perspective taking (social processes/mediators)
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Baseline, 2 month, 3 month, 9 month, 15 month
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Social functioning
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
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Changes in social functioning will be assessed by the Social Adjustment Scale-Self Report (SAS-SR), a 23-item scale of functioning in school (scores range from 6-30), with friends (scores range from 9-45), with family (scores range from 6-30), and dating (scores range from 2-10); a total score can also be computed (scores range from 23-115); higher scores indicate more difficulties in social functioning (social processes/mediators)
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Baseline, 2 month, 3 month, 9 month, 15 month
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Quality of relationships: Inventory of Parent and Peer Attachment (IPPA-45)
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
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Change in quality of relationships will be assessed by the Inventory of Parent and Peer Attachment (IPPA-45), a measure assessing the quality of mother (scores range from 15-75), father (scores range from 15-75), and peer relationships (scores range from 15-75); higher scores indicate more positive relationships (social processes/mediators)
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Baseline, 2 month, 3 month, 9 month, 15 month
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Parent-child conflict
Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month
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Changes in parent-child conflict will be assessed by the Conflict Behavior Questionnaire (CBQ), a 20-item questionnaire measuring conflict and negative communication between parents and adolescents; score range from 0-20; higher scores indicate more conflict (social processes/mediators)
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Baseline, 2 month, 3 month, 9 month, 15 month
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jami Young, PhD, CHOP, University of Pennsylvania Perelman School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-016323
- R305A190088 (Other Grant/Funding Number: U.S. Department of Education)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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