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

Depressive Symptoms Clinical Trial

— SAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04109716
• Other study ID #: 19-016323
• Secondary ID: R305A190088
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 242
• Est. completion date: June 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Adolescent 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

5. Have access to a cellular phone, computer, and/or tablet and have internet access to complete the remote intervention and evaluations

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

4. 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:

1. Parents of students in 9th or 10th grade between the ages of 14 and 17 at one of the participating schools

2. English or Spanish-speaking or limited English proficiency with use of interpreter

3. Consent to participate

4. 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:

1. 18 years of age or older

2. Knows the adolescent well enough to answer questions about him/her

3. English or Spanish-speaking or limited English proficiency with use of interpreter

4. Consent to participate

5. Have access to a phone, computer, and/or tablet to complete remote evaluations Exclusion Criteria: None For Counselor Participants

Inclusion Criteria:

1. Counselor at one of the participating high schools

2. Consent to participate

3. Have access to a phone, computer, and/or tablet to complete remote evaluations 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

3. Have access to a phone, computer, and/or tablet to complete remote evaluations Exclusion Criteria: None

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hopsital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Institute of Education Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perspective-taking	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)	Baseline, 2 month, 3 month, 9 month, 15 month
Other	Social functioning	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)	Baseline, 2 month, 3 month, 9 month, 15 month
Other	Quality of relationships: Inventory of Parent and Peer Attachment (IPPA-45)	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)	Baseline, 2 month, 3 month, 9 month, 15 month
Other	Parent-child conflict	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)	Baseline, 2 month, 3 month, 9 month, 15 month
Primary	Depression symptoms	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	Screen, baseline, 2 month, 3 month, 9 month, 15 month
Primary	Impairment	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	Baseline, 2 month, 3 month, 9 month, 15 month
Primary	Onset of depression diagnoses	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)	Eligibility, 15 month
Primary	Change in academic grades	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.	Baseline, 15 month
Primary	Change in school attendance	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.	Baseline, 15 month
Secondary	Internalizing and externalizing symptoms	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	Baseline, 2 month, 3 month, 9 month, 15 month
Secondary	Anxiety symptoms	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)	Baseline, 2 month, 3 month, 9 month, 15 month
Secondary	Number of disciplinary incidents	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	Baseline, 15 month
Secondary	School connectedness	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	Baseline, 3 month, 9 month, 15 month
Secondary	Emotional and behavioral engagement in learning	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	Baseline, 3 month, 9 month, 15 month
Secondary	Fidelity to the intervention	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)	Weekly during intervention delivery
Secondary	Acceptability - counselors: A self-report measure, Counselor Feedback Form	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)	3 month, 15 month
Secondary	Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)	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)	3 month, 15 month
Secondary	Patterns in qualitative data	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	3 month
Secondary	Attendance	Logs will track youth participation in IPT-AST and clinician attendance to IPT-AST consultation as one indicator of feasibility (implementation)	Weekly during IPT-AST