Testing FIRST in Youth Outpatient Psychotherapy

NCT04725721 | Active Not Recruiting DMC

• 1 other identifier: IRB20-1875
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 2

Brief Summary

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.

Conditions

Anxiety; Depression; Trauma; Behavior Problem

Keywords

anxiety; depression; trauma; behavior problems; youth; mental health; emotion regulation

Outcome Measures

Primary Outcomes (3)

• Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)

  The CBCL is a parent-report checklist with 113 youth problem items, each rated on a 0-1-2 scale (0 = not true, 1 = somewhat/sometimes true, 2 = very often true). The YSR is a corresponding 112-item youth-report checklist measure. From both the CBCL and the YSR, T-scores, adjusted for age and gender, Internalizing, Externalizing, and Total Problems scales will be used for outcome assessment. Higher scores represent more severe problems, with borderline and clinical cutoffs at T = 60 and T = 63, respectively. Evidence of CBCL/YSR validity and reliability is strong and extensive.

  Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)

• Behavior and Feelings Survey (BFS; Weisz et al., 2020)

  The 12-item BFS is a measure of internalizing (6 items), externalizing (6 items), and total problems, developed via four studies, three with samples of clinically referred youths aged 7-15 and their caregivers. Both youth and caregiver forms showed robust factor structure, internal consistency, test-retest reliability, convergent and discriminant validity in relation to three well-established symptom measures (including CBCL and YSR), and slopes of change indicating efficacy in monitoring treatment progress during therapy. Items are rated on a scale from 0 (not a problem) to 4 (a very big problem). Internalizing and externalizing scale scores range from 0 to 24 and total problems from 0 to 48 (with higher scores indicating greater problem severity).

  Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

• Functional Top Problems Assessment (TPA; Weisz et al., 2011)

  The TPA assesses youth and caregiver severity ratings (from 0 = not a problem to 4 = a very big problem) for the functional top three problems the youth and caregiver independently identified as most important to them, in separate baseline interviews. Psychometric analyses have shown strong test-retest reliability, convergent and discriminant validity for the TPA in relation to standardized measures, and sensitivity to change during treatment.

  Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

Secondary Outcomes (4)

• Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al., 1999; Ebesutani et al., 2011)

  Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

• Coping Questionnaire (CQ; Crane & Kendall, 2020)

  Change from baseline through end of treatment (weekly from 0 up to 78 weeks)

• Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID parent version; Sheehan et al., 2010)

  Change from baseline (0 months) to end of treatment (up to 78 weeks)

• UCLA PTSD Reaction Index (PTSDRI; Steinberg et al., 2004)

  Baseline for entire sample; quarterly (3, 6, 9, 12, and 18 months) for up to 18 months for those with elevated baseline PTS symptoms (from 0 up to 78 weeks)

Other Outcomes (11)

• Evidence-Based Practice Attitudes Scale (EBPAS-15; Aarons, 2004)

  Baseline

• Evidence-Based Treatment Intentions (EBTI; Williams, 2015)

  Baseline

• Knowledge of Evidence Based Services Questionnaire (KEBS-Q; Stumpf et al., 2009)

  Baseline, post-training (approx 2 weeks after training)

Study Arms (2)

FIRST

EXPERIMENTAL

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.

Behavioral: FIRST

Usual Care

ACTIVE COMPARATOR

Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.

Behavioral: Usual Care

Interventions

FIRST BEHAVIORAL

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

Usual Care BEHAVIORAL

Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.

Usual Care

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ages 7.0-15.9 years
• 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

You may not qualify if:

• current suicide risk, operationalized as active suicidal ideation or a history of suicide attempt or inpatient hospitalization for suicide risk within the last 3 months
• 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

Sponsors & Collaborators

• Harvard University: lead
• University of Texas at Austin: collaborator

Study Sites (2)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (21)

• 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.

  PMID: 32762554 BACKGROUND

• 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.

  PMID: 27442352 BACKGROUND

• 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: 30657721 BACKGROUND

• 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: 21500888 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21381834 BACKGROUND

• 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.

  PMID: 19135649 BACKGROUND

• 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.

  PMID: 32157488 BACKGROUND

• 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: 15224451 BACKGROUND

• 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.

  PMID: 15038911 BACKGROUND

• 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.

  PMID: 27150798 BACKGROUND

• 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.

  PMID: 21401270 BACKGROUND

• 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.

  PMID: 15796640 BACKGROUND

• 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.

  PMID: 32076887 BACKGROUND

• 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.

  PMID: 25984802 BACKGROUND

• 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.

  PMID: 20331933 BACKGROUND

• 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.

  PMID: 23377768 BACKGROUND

• 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.

  PMID: 23088205 BACKGROUND

• Institute of Behavioral Research. TCU Organizational Readiness for Change (ORC-D4). Fort Worth: Texas Christian University, Institute of Behavioral Research. 2009.

  BACKGROUND

• 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.

  PMID: 37864269 DERIVED

• 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.

  PMID: 37720052 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression; Wounds and Injuries; Mental Disorders; Psychological Well-Being; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2021
• First Posted: January 27, 2021
• Study Start: September 27, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be uploaded biannually per the NIH requirements starting in 2023. IPD will be available once the study findings are accepted for publication.
• Access Criteria: \- IPD can be accessed by scientific investigators by requesting data directly from the NDA. The NDA Data Access Committee will determine whether the proposed use of the dataset including the types of analyses is ethically appropriate and provide approval for researchers to access data uploaded to the NDA.

Locations

US (2)