NCT02877875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

5.6 years

First QC Date

January 6, 2015

Last Update Submit

March 8, 2021

Conditions

Keywords

anxietydepressiontraumabehavior problemsevidence-based treatmentsmanualized treatmentscognitive-behavioral therapyyouthmental health

Outcome Measures

Primary Outcomes (7)

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

    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 over time from Baseline (Day 1) through study completion (up to 66 weeks)

  • Change in internalizing and externalizing problems per teacher-report.

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

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

    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.

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

  • Change in top problems per teacher-report.

    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.

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

  • Academic outcomes, assessed via school grades and standardized test performance

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

    Yearly, assessed up to 52 weeks

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

    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 over time from Baseline (Day 1) through study completion (up to 66 weeks)

  • Change in school engagement per teacher-report.

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

Secondary Outcomes (22)

  • Youth Self-Report (YSR)

    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)

  • Teacher Report Form (TRF)

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

  • 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)

  • Services Assessment for Children and Adolescents (SACA)

    Baseline (Day 1) through study completion (up to 66 weeks)

  • +17 more secondary outcomes

Study Arms (2)

Child STEPS

EXPERIMENTAL

Child STEPs includes (1) a treatment protocol, Modular Approach to Therapy for Children with Anxiety, Depression, Trauma or Conduct Problems (MATCH-ADTC;Chorpita \& Weisz, 2009), and (2) a youth monitoring and feedback system (MFS).

Behavioral: Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct ProblemsOther: Monitoring and Feedback System

Usual Care

ACTIVE COMPARATOR

Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective, and researchers will not influence their work.

Behavioral: Treatment as usual

Interventions

MATCH-ADTC (Chorpita \& Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with Attention-deficit/hyperactivity disorder (ADHD). MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.

Also known as: MATCH, MATCH - ADTC
Child STEPS

For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Feelings Survey and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all the weeks of treatment.

Also known as: MFS
Child STEPS

Treatment in the UC condition will use the procedures therapists (e.g., school counselors) and their supervisors consider appropriate and believe to be effective.

Also known as: Usual Care, UC
Usual Care

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (17)

  • Weisz JR, Chorpita BF, Palinkas LA, Schoenwald SK, Miranda J, Bearman SK, Daleiden EL, Ugueto AM, Ho A, Martin J, Gray J, Alleyne A, Langer DA, Southam-Gerow MA, Gibbons RD; Research Network on Youth Mental Health. Testing standard and modular designs for psychotherapy treating depression, anxiety, and conduct problems in youth: a randomized effectiveness trial. Arch Gen Psychiatry. 2012 Mar;69(3):274-82. doi: 10.1001/archgenpsychiatry.2011.147. Epub 2011 Nov 7.

    PMID: 22065252BACKGROUND
  • 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.

    PMID: 21500888BACKGROUND
  • Goodman A, Lamping DL, Ploubidis GB. When to use broader internalising and externalising subscales instead of the hypothesised five subscales on the Strengths and Difficulties Questionnaire (SDQ): data from British parents, teachers and children. J Abnorm Child Psychol. 2010 Nov;38(8):1179-91. doi: 10.1007/s10802-010-9434-x.

    PMID: 20623175BACKGROUND
  • Addis ME, Krasnow AD. A national survey of practicing psychologists' attitudes toward psychotherapy treatment manuals. J Consult Clin Psychol. 2000 Apr;68(2):331-9. doi: 10.1037//0022-006x.68.2.331.

    PMID: 10780134BACKGROUND
  • Shields A, Cicchetti D. Emotion regulation among school-age children: the development and validation of a new criterion Q-sort scale. Dev Psychol. 1997 Nov;33(6):906-16. doi: 10.1037//0012-1649.33.6.906.

    PMID: 9383613BACKGROUND
  • Shipman KL, Zeman J. Socialization of children's emotion regulation in mother-child dyads: a developmental psychopathology perspective. Dev Psychopathol. 2001 Spring;13(2):317-36. doi: 10.1017/s0954579401002073.

    PMID: 11393649BACKGROUND
  • Nolen-Hoeksema S, Morrow J. A prospective study of depression and posttraumatic stress symptoms after a natural disaster: the 1989 Loma Prieta Earthquake. J Pers Soc Psychol. 1991 Jul;61(1):115-21. doi: 10.1037//0022-3514.61.1.115.

    PMID: 1890582BACKGROUND
  • Weisz JR, Southam-Gerow MA, McCarty CA. Control-related beliefs and depressive symptoms in clinic-referred children and adolescents: developmental differences and model specificity. J Abnorm Psychol. 2001 Feb;110(1):97-109. doi: 10.1037//0021-843x.110.1.97.

    PMID: 11261405BACKGROUND
  • Orpinas P, Horne AM; Multisite Violence Prevention Project. A teacher-focused approach to prevent and reduce students' aggressive behavior: the GREAT Teacher Program. Am J Prev Med. 2004 Jan;26(1 Suppl):29-38. doi: 10.1016/j.amepre.2003.09.016.

    PMID: 14732185BACKGROUND
  • Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.

    PMID: 8126686BACKGROUND
  • Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the Evidence-Based Practice Attitude Scale (EBPAS). Ment Health Serv Res. 2004 Jun;6(2):61-74. doi: 10.1023/b:mhsr.0000024351.12294.65.

    PMID: 15224451BACKGROUND
  • Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.

    PMID: 30657721BACKGROUND
  • Achenbach TM. International findings with the Achenbach System of Empirically Based Assessment (ASEBA): applications to clinical services, research, and training. Child Adolesc Psychiatry Ment Health. 2019 Jul 5;13:30. doi: 10.1186/s13034-019-0291-2. eCollection 2019.

    PMID: 31312253BACKGROUND
  • Jensen PS, Eaton Hoagwood K, Roper M, Arnold LE, Odbert C, Crowe M, Molina BS, Hechtman L, Hinshaw SP, Hoza B, Newcorn J, Swanson J, Wells K. The services for children and adolescents-parent interview: development and performance characteristics. J Am Acad Child Adolesc Psychiatry. 2004 Nov;43(11):1334-44. doi: 10.1097/01.chi.0000139557.16830.4e.

    PMID: 15502592BACKGROUND
  • Weisz JR. Contingency and control beliefs as predictors of psychotherapy outcomes among children and adolescents. J Consult Clin Psychol. 1986 Dec;54(6):789-95. doi: 10.1037//0022-006x.54.6.789. No abstract available.

    PMID: 3794023BACKGROUND
  • Weisz JR, Stipek DJ. Competence, contingency, and the development of perceived control. Hum Dev. 1982;25(4):250-81. doi: 10.1159/000272812. No abstract available.

    PMID: 7141442BACKGROUND
  • Harmon SL, Price MA, Corteselli KA, Lee EH, Metz K, Bonadio FT, Hersh J, Marchette LK, Rodriguez GM, Raftery-Helmer J, Thomassin K, Bearman SK, Jensen-Doss A, Evans SC, Weisz JR. Evaluating a Modular Approach to Therapy for Children With Anxiety, Depression, Trauma, or Conduct Problems (MATCH) in School-Based Mental Health Care: Study Protocol for a Randomized Controlled Trial. Front Psychol. 2021 Mar 5;12:639493. doi: 10.3389/fpsyg.2021.639493. eCollection 2021.

MeSH Terms

Conditions

Anxiety DisordersDepressionWounds and InjuriesMental DisordersPsychological Well-Being

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • John R. Weisz

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Principal Investigator

Study Record Dates

First Submitted

January 6, 2015

First Posted

August 24, 2016

Study Start

January 1, 2015

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations