Student Outcomes of Integrative Mental Health Services

NCT ID: NCT02877875

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Anxiety Depression Trauma Behavior Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Child STEPS

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).

Group Type EXPERIMENTAL

Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems

Intervention Type BEHAVIORAL

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.

Monitoring and Feedback System

Intervention Type OTHER

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.

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

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

Interventions

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Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems

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.

Intervention Type BEHAVIORAL

Monitoring and Feedback System

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.

Intervention Type OTHER

Treatment as usual

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

Intervention Type BEHAVIORAL

Other Intervention Names

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MATCH MATCH - ADTC MFS Usual Care UC

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard University

OTHER

Sponsor Role lead

Responsible Party

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John Weisz

Professor and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John R. Weisz

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

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Harvard University

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22065252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21500888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20623175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10780134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9383613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11393649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1890582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11261405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14732185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8126686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15224451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30657721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31312253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15502592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3794023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7141442 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33746857 (View on PubMed)

Other Identifiers

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R305A140253

Identifier Type: -

Identifier Source: org_study_id

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