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Clinical Trials/NCT02877875
NCT02877875
Completed
N/A

Student Outcomes of Integrative Mental Health Services

Harvard University1 site in 1 country143 target enrollmentJanuary 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Harvard University
Enrollment
143
Locations
1
Primary Endpoint
Change in top problems per youth- and caregiver-report.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual school-based therapy on students' mental health and school-related outcomes, and test whether changes in school outcomes are mediated by changes in student mental health.

Detailed Description

This project will implement and evaluate the Child STEPs (see Weisz et al., 2012) treatment approach through a randomized controlled trial (RCT) at 27 K-8 public schools. The STEPs model has two components: (1) a modular protocol that combines 33 modules-i.e., descriptions of common elements within evidence-based therapies for anxiety, depression, post-traumatic stress, and conduct problems; and (2) a web-based system for monitoring student responses to treatment and providing weekly feedback to therapists, to guide their selection and sequencing of the STEPs modules. The project will include an evaluation of the effectiveness of STEPS compared to "treatment as usual" (known as Usual Care or UC) on students' mental health and school-related outcomes, and an analysis of whether changes in school outcomes are mediated by changes in student mental health.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John Weisz

Professor and Principal Investigator

Harvard University

Eligibility Criteria

Inclusion Criteria

  • Enrolled in grades 2-7
  • Have a primary clinical problem in the areas of anxiety, depression, conduct, or posttraumatic stress
  • Clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-traumatic Stress Disorder Reaction Index

Exclusion Criteria

  • Mental retardation
  • Pervasive developmental disorder
  • Eating disorders
  • Children for whom attention problems or hyperactivity are the primary referral concern
  • Active psychosis and/or a suicide attempt in the previous year

Outcomes

Primary Outcomes

Change in top problems per youth- and caregiver-report.

Time Frame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)

The Top Problems Assessment-Youth and Caregiver Report (TPA- Youth and Caregiver) is a brief idiographic instrument designed to help identify and monitor youth problems that are especially important from the perspectives of the youth and caregiver. The TPA- Youth and Caregiver were shown to complement standardized measures and offer incremental utility, with evidence of test- retest reliability, convergent and discriminant validity, and sensitivity to change during treatment. The TPA-Youth and Caregiver is administered weekly.

Academic outcomes, assessed via school grades and standardized test performance

Time Frame: Yearly, assessed up to 52 weeks

Academic outcomes as obtained through class grades and standardized school testing.

Change in school engagement per self- and caregiver-report.

Time Frame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)

The National Survey of American Families (NSAF-Youth and Caregiver) School Engagement Scale is a youth- and caregiver-reported is a measure of behavioral, emotional, and cognitive engagement in school. Respondents rate youth on a four-point scale on items assessing whether the youth cares about doing well in school, only works on schoolwork when forced to, does just enough schoolwork to get by, and always does their homework

Change in school engagement per teacher-report.

Time Frame: Change over time from Baseline (Day 1) through Post-treatment (up to 34 weeks)

The National Survey of American Families (NSAF-Teacher) School Engagement Scale is a measure of behavioral, emotional, and cognitive engagement in school. Respondents rate youth on a four-point scale on items assessing whether the youth cares about doing well in school, only works on schoolwork when forced to, does just enough schoolwork to get by, and always does their homework. NSAF-Teacher is administered monthly.

Change in internalizing and externalizing problems per self- and caregiver-report.

Time Frame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)

The Behavior and Feelings Survey-Youth and Caregiver Report (BFS-Youth and Caregiver) is a no-cost, 12-item, youth- and caregiver-report measure of internalizing and externalizing problems. The BFS-Youth and Caregiver showed robust factor structure, internal consistency, test-retest reliability, and slopes of change indicating efficacy in monitoring treatment progress during psychotherapy in four samples of youths aged 7-15 years. The BFS-Youth and Caregiver is administered weekly.

Change in internalizing and externalizing problems per teacher-report.

Time Frame: Change over time from Baseline (Day 1) through post-treatment (up to 34 weeks)

The Behavior and Feelings Survey-Teacher Report (BFS-Teacher) is a no-cost, 12-item, teacher-report measure of internalizing and externalizing problems. The BFS-Teacher showed robust factor structure, internal consistency, test-retest reliability, and slopes of change indicating efficacy in monitoring treatment progress during psychotherapy in four samples of youths aged 7-15 years. The BFS-Teacher is administered monthly.

Change in top problems per teacher-report.

Time Frame: Change over time from Baseline (Day 1) through Post-treatment (up to 34 weeks)

The Top Problems Assessment-Teacher Report (TPA-Teacher) is a brief idiographic instrument designed to help identify and monitor youth problems that are especially important from the perspectives of the youth's teacher. The TPA-Teacher has not yet been examined psychometrically. The TPA-Youth and Caregiver is administered monthly.

Secondary Outcomes

  • University of California at Los Angeles (UCLA) Post-traumatic Stress Disorder Reaction Index(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Youth Satisfaction Questionnaire(Post-treatment, assessed up to 42 weeks after baseline)
  • Therapeutic Alliance Scale (TASC)(Post-treatment, assessed up to 42 weeks after baseline)
  • The Children's Emotion Management Scale (CEMS)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Perceived Control Scale for Children (PCSC)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Reduced Aggression and Victimization Scales (RAVS)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Youth Self-Report (YSR)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Services Assessment for Children and Adolescents (SACA)(Baseline (Day 1) through study completion (up to 66 weeks))
  • Medication Questionnaire adapted from the Services for Children and Adolescents-Parent Interview (SCA-PI)(Baseline (Day 1) through study completion (up to 66 weeks))
  • Brief Symptom Inventory (BSI)(Baseline (Day 1))
  • Teacher Report Form (TRF)(Change over time from Baseline (Day 1) to Post-treatment (up to 34 weeks))
  • Therapist Satisfaction Inventory (TSI)(Post-treatment, assessed up to 42 weeks after baseline)
  • Emotion Regulation Checklist (ERC)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • The Children's Response Style Questionnaire (CRSQ)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Child Behavior Checklist (CBCL)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Caregiver Satisfaction Questionnaire(Post-treatment, assessed up to 42 weeks after baseline)
  • Secondary Control Scale for Children (SCSC)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Children's Alexithymia Scale (CAS)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • The School Engagement Measure-MacArthur Network(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Implicit Theories of Thoughts, Emotions, and Behaviors Scale (ITEB-Q)(Change over time from Baseline (Day 1) through study completion (up to 66 weeks))
  • Evidence-Based Practice Attitudes Scale (EBPAS)(Change over time from Baseline (Day 1) to Post-treatment (up to 42 weeks))
  • Academic Competence Evaluation Scales(Change over time from Baseline (Day 1) to Post-treatment (up to 34 weeks))

Study Sites (1)

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