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School Adolescent Mood Project: Efficacy of IPT-AST in Schools (SAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109716
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : March 14, 2022
Sponsor:
Collaborator:
Institute of Education Sciences
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
This school-based randomized controlled trial will: a) examine the effects of telehealth-administered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program, as compared to services as usual (SAU) on social processes and emotional and school outcomes, b) examine moderators and mediators of intervention effects, and c) assess the costs, cost-effectiveness, acceptability, feasibility, fidelity, and sustainability of IPT-AST.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: Interpersonal Psychotherapy - Adolescent Skills Training Behavioral: Services as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: School Adolescent Mood Project: Efficacy of IPT-AST in Schools
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


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.
Behavioral: Interpersonal Psychotherapy - Adolescent Skills Training
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.

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.
Behavioral: Services as usual
Services as usual is expected to be brief periodic sessions (in person or remote) with the school counselor or services in the community.




Primary Outcome Measures :
  1. Depression symptoms [ Time Frame: Screen, baseline, 2 month, 3 month, 9 month, 15 month ]
    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

  2. Impairment [ Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month ]
    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

  3. Onset of depression diagnoses [ Time Frame: Eligibility, 15 month ]
    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)

  4. Change in academic grades [ Time Frame: Baseline, 15 month ]
    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.

  5. Change in school attendance [ Time Frame: Baseline, 15 month ]
    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.


Secondary Outcome Measures :
  1. 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

  2. Anxiety symptoms [ Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month ]
    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)

  3. Number of disciplinary incidents [ Time Frame: Baseline, 15 month ]
    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

  4. School connectedness [ Time Frame: Baseline, 3 month, 9 month, 15 month ]
    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

  5. Emotional and behavioral engagement in learning [ Time Frame: Baseline, 3 month, 9 month, 15 month ]
    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

  6. Fidelity to the intervention [ Time Frame: Weekly during intervention delivery ]
    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)

  7. Acceptability - counselors: A self-report measure, Counselor Feedback Form [ Time Frame: 3 month, 15 month ]
    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)

  8. Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI) [ Time Frame: 3 month, 15 month ]
    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)

  9. Patterns in qualitative data [ Time Frame: 3 month ]
    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

  10. Attendance [ Time Frame: Weekly during IPT-AST ]
    Logs will track youth participation in IPT-AST and clinician attendance to IPT-AST consultation as one indicator of feasibility (implementation)


Other Outcome Measures:
  1. Perspective-taking [ Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month ]
    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)

  2. Social functioning [ Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month ]
    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)

  3. Quality of relationships: Inventory of Parent and Peer Attachment (IPPA-45) [ Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month ]
    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)

  4. Parent-child conflict [ Time Frame: Baseline, 2 month, 3 month, 9 month, 15 month ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Adolescent and Parent Participants

Inclusion Criteria:

  1. Adolescents in 9th or 10th grade between the ages of 14 and 17
  2. Adolescent must be English-speaking; parents must be English or Spanish-speaking
  3. Parental/guardian permission (informed consent) and child assent/consent
  4. A score of 16 or higher on the CES-D AND at least 2 threshold or subthreshold symptoms on the K-SADS-PL

Exclusion Criteria:

  1. Less than 2 threshold or subthreshold symptoms on the K-SADS-PL
  2. 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
  3. Significant cognitive or language impairments requiring placement in Special Education as reported by the parent or as evident in the eligibility evaluation

For Counselor Participants

Inclusion Criteria:

  1. Counselor at one of the participating high schools
  2. Consent to participate

Exclusion Criteria:

None

For Teacher and Administrator Participants

Inclusion Criteria:

  1. Teacher or administrator at one of the participating high schools
  2. Consent to participate in the qualitative interview

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109716


Contacts
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Contact: Jami F Young, PhD 267-425-1328 youngjf@chop.edu
Contact: Jason Jones, PhD 267-425-1326 jonesjd@chop.edu

Locations
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United States, Pennsylvania
Children's Hopsital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Jami Young, PhD    267-425-1328    youngjf@chop.edu   
Principal Investigator: Jami Young, PhD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Institute of Education Sciences
Investigators
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Principal Investigator: Jami Young, PhD CHOP, University of Pennsylvania Perelman School of Medicine
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04109716    
Other Study ID Numbers: 19-016323
R305A190088 ( Other Grant/Funding Number: U.S. Department of Education )
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The raw data will be entered into a de-identified electronic database and double-checked for accuracy. After data cleaning and quality assurance procedures are completed, pertinent sets of data will be converted into analytic datasets for statistical analyses. Additional variables may be derived for data analysis purposes. The cleaned, de-identified dataset, including additional derived variables, will be made accessible per IES data access requirements at the time that findings are published in a peer-reviewed journal. Data will be available for 10 years from that time.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The cleaned, de-identified dataset, including additional derived variables, will be made accessible per IES data access requirements at the time that findings are published in a peer-reviewed journal. Data will be available for 10 years from that time.
Access Criteria: Individuals interested in using the data should contact Dr. Young to make a request. Only de-identified data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms