Study Results
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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RECRUITING
NA
212 participants
INTERVENTIONAL
2021-09-27
2026-02-28
Brief Summary
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Detailed Description
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This randomized controlled effectiveness trial will provide a more definitive test of FIRST, an initial investigation of a candidate mechanism of change, and tests of therapist characteristics that may predict and moderate implementation of evidence-based practices. The sample will be ethnically and economically diverse youths, ages 7-15, from four community clinics-two in greater Boston MA, two in greater Austin TX-all referred by their families and all showing elevated depression, anxiety/OCD, post-traumatic stress, or conduct problems. Clinicians within each clinic will be randomly assigned to learn and use FIRST or to employ Usual Care (UC), and youths will be randomized to FIRST or UC. Clinical outcomes will include change on standardized measures of mental health and on severity of the specific problems identified as most important by each youth and each caregiver at baseline. Study measures will include a proposed mechanism-regulation of negative emotions- thought to be responsive to treatment and responsible for changes in mental health. Analyses will assess whether treatment with FIRST impacts regulation, and whether improved regulation accounts for outcomes of FIRST treatment relative to UC. Finally, the study will investigate whether clinicians' baseline knowledge of, attitudes toward, and motivation to use evidence-based practices predicts or moderates their implementation of such practices in psychotherapy. The study will thus provide the first randomized trial of this new practice-adapted transdiagnostic treatment, plus an inquiry into the process through which it may work and therapist factors that may strengthen or weaken implementation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FIRST
FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.
FIRST
FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.
Usual Care
Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.
Usual Care
Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.
Interventions
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FIRST
FIRST is built upon five empirically supported principles of change (ESPCs-i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, trying the opposite). Each principle can be applied to treatment of problems spanning depression, anxiety (including OCD and PTS), and conduct problems-thus encompassing a majority of the youths seen in outpatient care. Its design addresses breadth of problem coverage, youth comorbidity, and flux in youth treatment needs during episodes of care. It is used in conjunction with performance feedback via a web-based tracking system that gives clinicians weekly data on youth treatment response. FIRST has treatment and training efficiency, and efficient clinician skill-building is supported by group consultation.
Usual Care
Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.
Eligibility Criteria
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Inclusion Criteria
* at least one clinically-relevant CBCL subscale score indicating borderline/clinical-range anxiety, depression, conduct problems, or post-traumatic stress
* English fluency indicated by taking all school classes in English
Exclusion Criteria
* presence of an eating disorder, schizophrenia spectrum disorder, autism spectrum disorder, or intellectual disability requiring special class placement in school
* referral for ADHD if specifically and exclusively to address inattentiveness and/or hyperactivity-impulsivity
7 Years
15 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Harvard University
OTHER
Responsible Party
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John Weisz
Professor
Locations
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Harvard University
Cambridge, Massachusetts, United States
University of Texas at Austin
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Cho E, Bearman SK, Woo R, Weisz JR, Hawley KM. A Second and Third Look at FIRST: Testing Adaptations of A Principle-Guided Youth Psychotherapy. J Clin Child Adolesc Psychol. 2021 Nov-Dec;50(6):919-932. doi: 10.1080/15374416.2020.1796678. Epub 2020 Aug 7.
Weisz J, Bearman SK, Santucci LC, Jensen-Doss A. Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents. J Clin Child Adolesc Psychol. 2017 Jan-Feb;46(1):44-58. doi: 10.1080/15374416.2016.1163708. Epub 2016 Jul 21.
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.
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.
Laurent J, Catanzaro SJ, Joiner TE, Rudolph KD, Potter KI, Lambert S, Osborne L, Gathright T. A measure of positive and negative affect for children: Scale development and preliminary validation. Psychological Assessment. 1999; 11(3): 326-338.
Ebesutani C, Okamura K, Higa-McMillan C, Chorpita BF. A psychometric analysis of the Positive and Negative Affect Schedule for Children-Parent Version in a school sample. Psychol Assess. 2011 Jun;23(2):406-16. doi: 10.1037/a0022057.
Daughters SB, Reynolds EK, MacPherson L, Kahler CW, Danielson CK, Zvolensky M, Lejuez CW. Distress tolerance and early adolescent externalizing and internalizing symptoms: the moderating role of gender and ethnicity. Behav Res Ther. 2009 Mar;47(3):198-205. doi: 10.1016/j.brat.2008.12.001. Epub 2008 Dec 13.
Crane ME, Kendall PC. Psychometric Evaluation of the Child and Parent Versions of the Coping Questionnaire. Child Psychiatry Hum Dev. 2020 Oct;51(5):709-720. doi: 10.1007/s10578-020-00975-w.
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.
Steinberg AM, Brymer MJ, Decker KB, Pynoos RS. The University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index. Curr Psychiatry Rep. 2004 Apr;6(2):96-100. doi: 10.1007/s11920-004-0048-2.
Williams NJ. Assessing mental health clinicians' intentions to adopt evidence-based treatments: reliability and validity testing of the evidence-based treatment intentions scale. Implement Sci. 2016 May 5;11:60. doi: 10.1186/s13012-016-0417-3.
Shirk SR, Karver MS, Brown R. The alliance in child and adolescent psychotherapy. Psychotherapy (Chic). 2011 Mar;48(1):17-24. doi: 10.1037/a0022181.
McLeod BD, Weisz JR. The therapy process observational coding system-alliance scale: measure characteristics and prediction of outcome in usual clinical practice. J Consult Clin Psychol. 2005 Apr;73(2):323-33. doi: 10.1037/0022-006X.73.2.323.
Lawson GM, Moore TM, Okamura KH, Becker-Haimes EM, Beidas RS. Knowledge of Evidence-Based Services Questionnaire: Development and Validation of a Short Form. Adm Policy Ment Health. 2020 Jul;47(4):581-596. doi: 10.1007/s10488-020-01020-7.
Chorpita BF, Park A, Tsai K, Korathu-Larson P, Higa-McMillan CK, Nakamura BJ, Weisz JR, Krull J; Research Network on Youth Mental Health. Balancing effectiveness with responsiveness: Therapist satisfaction across different treatment designs in the Child STEPs randomized effectiveness trial. J Consult Clin Psychol. 2015 Aug;83(4):709-18. doi: 10.1037/a0039301. Epub 2015 May 18.
Sheehan DV, Sheehan KH, Shytle RD, Janavs J, Bannon Y, Rogers JE, Milo KM, Stock SL, Wilkinson B. Reliability and validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID). J Clin Psychiatry. 2010 Mar;71(3):313-26. doi: 10.4088/JCP.09m05305whi.
Fukui S, Rapp CA, Goscha R, Marty D, Ezell M. The perceptions of supervisory support scale. Adm Policy Ment Health. 2014 May;41(3):353-9. doi: 10.1007/s10488-013-0470-z.
Accurso EC, Hawley KM, Garland AF. Psychometric properties of the Therapeutic Alliance Scale for Caregivers and Parents. Psychol Assess. 2013 Mar;25(1):244-52. doi: 10.1037/a0030551. Epub 2012 Oct 22.
Institute of Behavioral Research. TCU Organizational Readiness for Change (ORC-D4). Fort Worth: Texas Christian University, Institute of Behavioral Research. 2009.
Bailin A, Cho E, Sternberg A, Evans SC, Hollinsaid NL, Bearman SK, Weisz JR. Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics. Trials. 2023 Oct 21;24(1):682. doi: 10.1186/s13063-023-07717-y.
Bailin A, Cho E, Sternberg A, Evans SC, Hollinsaid NL, Kate Bearman S, Weisz JR. Principle-Guided Psychotherapy for Children and Adolescents (FIRST): Study Protocol for a Randomized Controlled Effectiveness Trial in Outpatient Clinics. Res Sq [Preprint]. 2023 Sep 8:rs.3.rs-3210987. doi: 10.21203/rs.3.rs-3210987/v1.
Other Identifiers
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IRB20-1875
Identifier Type: -
Identifier Source: org_study_id
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