Clinical trial NCT02877875: Student Outcomes of Integrative Mental Health Services
Official title: Student Outcomes of Integrative Mental Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Trauma
Behavior Problems
Keywords: anxiety
depression
trauma
behavior problems
evidence-based treatments
manualized treatments
cognitive-behavioral therapy
youth
mental health
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 143
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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 Clinically elevated problem levels on the Internalizing, Externalizing, Anxious-Depressed, Withdrawn-Depressed, Aggressive Behavior, or Rule-Breaking Behavior scales of the Child Behavior Checklist or Youth Self-Report or on the UCLA Post-traumatic Stress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

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

Primary outcomes:
measure: Change in internalizing and externalizing problems per self- and caregiver-report.
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Change in internalizing and externalizing problems per teacher-report.
timeFrame: Change over time from Baseline (Day 1) through post-treatment (up to 34 weeks)
measure: Change in top problems per youth- and caregiver-report.
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Change in top problems per teacher-report.
timeFrame: Change over time from Baseline (Day 1) through Post-treatment (up to 34 weeks)
measure: Academic outcomes, assessed via school grades and standardized test performance
timeFrame: Yearly, assessed up to 52 weeks
measure: Change in school engagement per self- and caregiver-report.
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Change in school engagement per teacher-report.
timeFrame: Change over time from Baseline (Day 1) through Post-treatment (up to 34 weeks)
Secondary outcomes:
measure: Youth Self-Report (YSR)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Child Behavior Checklist (CBCL)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Teacher Report Form (TRF)
timeFrame: Change over time from Baseline (Day 1) to Post-treatment (up to 34 weeks)
measure: University of California at Los Angeles (UCLA) Post-traumatic Stress Disorder Reaction Index
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Services Assessment for Children and Adolescents (SACA)
timeFrame: Baseline (Day 1) through study completion (up to 66 weeks)
measure: Medication Questionnaire adapted from the Services for Children and Adolescents-Parent Interview (SCA-PI)
timeFrame: Baseline (Day 1) through study completion (up to 66 weeks)
measure: Therapeutic Alliance Scale (TASC)
timeFrame: Post-treatment, assessed up to 42 weeks after baseline
measure: Caregiver Satisfaction Questionnaire
timeFrame: Post-treatment, assessed up to 42 weeks after baseline
measure: Youth Satisfaction Questionnaire
timeFrame: Post-treatment, assessed up to 42 weeks after baseline
measure: Therapist Satisfaction Inventory (TSI)
timeFrame: Post-treatment, assessed up to 42 weeks after baseline
measure: Emotion Regulation Checklist (ERC)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Brief Symptom Inventory (BSI)
timeFrame: Baseline (Day 1)
measure: The Children's Emotion Management Scale (CEMS)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: The Children's Response Style Questionnaire (CRSQ)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Perceived Control Scale for Children (PCSC)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Secondary Control Scale for Children (SCSC)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Reduced Aggression and Victimization Scales (RAVS)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Implicit Theories of Thoughts, Emotions, and Behaviors Scale (ITEB-Q)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Children's Alexithymia Scale (CAS)
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
measure: Evidence-Based Practice Attitudes Scale (EBPAS)
timeFrame: Change over time from Baseline (Day 1) to Post-treatment (up to 42 weeks)
measure: Academic Competence Evaluation Scales
timeFrame: Change over time from Baseline (Day 1) to Post-treatment (up to 34 weeks)
measure: The School Engagement Measure-MacArthur Network
timeFrame: Change over time from Baseline (Day 1) through study completion (up to 66 weeks)
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard University
name: John R. Weisz
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Weisz JR, Chorpita BF, Frye A, Ng MY, Lau N, Bearman SK, Ugueto AM, Langer DA, Hoagwood KE; Research Network on Youth Mental Health. Youth Top Problems: using idiographic, consumer-guided assessment to identify treatment needs and to track change during psychotherapy. J Consult Clin Psychol. 2011 Jun;79(3):369-80. doi: 10.1037/a0023307.
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