Study Summary
This trial will compare the effectiveness of a new transdiagnostic treatment against usual care outpatient psychotherapy, for youths' mental health outcomes. The new treatment is based on five principles of change, and one proposed mechanism of change is regulation of negative emotions.
Eligible Conditions
- Depression
- Anxiety
- Trauma
- Behavioral Problem
Treatment Effectiveness
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)
Week 78
Therapist Integrity in Evidence-Based Interventions (TIEBI; Jensen et al., 2004)
Therapy Process Observational Coding System-Alliance Scale (TPOCS-A; McLeod & Weisz, 2005)
Week 78
Parent and Child Satisfaction Scales (PCSS)
Month 18
UCLA PTSD Reaction Index (PTSDRI; Steinberg et al., 2004)
Baseline only (day 0)
TCU Organizational Readiness for Change (TCU-ORC; Organizational Climate Scale; Institute of Behavioral Research, 2009)
Month 0
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID parent version; Sheehan et al., 2010)
Day 14
Evidence-Based Practice Attitudes Scale (EBPAS-15; Aarons, 2004)
Evidence-Based Treatment Intentions (EBTI; Williams, 2015)
Knowledge of Evidence Based Services Questionnaire (KEBS-Q; Stumpf et al., 2009)
Week 78
Behavior and Feelings Survey (BFS; Weisz et al., 2020)
Coping Questionnaire (CQ; Crane & Kendall, 2020)
Functional Top Problems Assessment (TPA; Weisz et al., 2011)
Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al., 1999; Ebesutani et al., 2011)
Month 18
Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)
Immediately after treatment
Therapist Satisfaction Index (TSI; Chorpita et al., 2015)
Week 78
Therapeutic Alliance Scale for Children and Caregivers/Parents(TASC-r; Shirk et al., 2011; TASCP; Accurso et al., 2013)
Week 78
Engagement of families in treatment
Perceptions of Supervisory Support Scale (PSSS; Fukui et al., 2014)
Trial Safety
Trial Design
2 Treatment Groups
Usual Care
1 of 2
FIRST
1 of 2
Active Control
Experimental Treatment
212 Total Participants · 2 Treatment Groups
Primary Treatment: FIRST · No Placebo Group · N/A
FIRST
Behavioral
Experimental Group · 1 Intervention: FIRST · Intervention Types: BehavioralUsual Care
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to 18 months (quarterly at 0, 3, 6, 9, 12, and 18 months from 0 up to 78 weeks)
Who is running the clinical trial?
Harvard UniversityLead Sponsor
213 Previous Clinical Trials
18,228,311 Total Patients Enrolled
23 Trials studying Depression
5,528 Patients Enrolled for Depression
University of Texas at AustinOTHER
289 Previous Clinical Trials
67,155 Total Patients Enrolled
21 Trials studying Depression
3,117 Patients Enrolled for Depression
Eligibility Criteria
Age 7 - 15 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:This group of people is in the age range of 7.0-15.9 years old.
At least one clinically-relevant CBCL subscale score indicating borderline/clinical-range anxiety, depression, conduct problems, or post-traumatic stress was found in 73% of the studies.
Students who take all their school classes in English are considered to be fluent in English
References
- Weisz, John, Sarah Kate Bearman, Lauren C. Santucci, and Amanda Jensen-Doss. 2016. “Initial Test of a Principle-guided Approach to Transdiagnostic Psychotherapy with Children and Adolescents”. Journal of Clinical Child & Adolescent Psychology. Informa UK Limited. doi:10.1080/15374416.2016.1163708.
- Cho, Evelyn, Sarah Kate Bearman, Rebecca Woo, John R. Weisz, and Kristin M. Hawley. 2020. “A Second and Third Look at FIRST: Testing Adaptations of A Principle-guided Youth Psychotherapy”. Journal of Clinical Child & Adolescent Psychology. Informa UK Limited. doi:10.1080/15374416.2020.1796678.
- Ebesutani, Chad, Kelsie Okamura, Charmaine Higa-McMillan, and Bruce F. Chorpita. 2011. “A Psychometric Analysis of the Positive and Negative Affect Schedule for Children–parent Version in a School Sample.”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/a0022057.
- Daughters, Stacey B., Elizabeth K. Reynolds, Laura MacPherson, Christopher W. Kahler, Carla K. Danielson, Michael Zvolensky, and C.W. Lejuez. 2009. “Distress Tolerance and Early Adolescent Externalizing and Internalizing Symptoms: The Moderating Role of Gender and Ethnicity”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/j.brat.2008.12.001.
- Crane, Margaret E., and Philip C. Kendall. 2020. “Psychometric Evaluation of the Child and Parent Versions of the Coping Questionnaire”. Child Psychiatry & Human Development. Springer Science and Business Media LLC. doi:10.1007/s10578-020-00975-w.
- Accurso, Erin C., Kristin M. Hawley, and Ann F. Garland. 2013. “Psychometric Properties of the Therapeutic Alliance Scale for Caregivers and Parents.”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/a0030551.
- Aarons, Gregory A.. 2004. “Mental Health Provider Attitudes Toward Adoption of Evidence-based Practice: The Evidence-based Practice Attitude Scale (EBPAS)”. Mental Health Services Research. Springer Science and Business Media LLC. doi:10.1023/b:mhsr.0000024351.12294.65.
- McLeod, Bryce D., and John R. Weisz. 2005. “The Therapy Process Observational Coding System-alliance Scale: Measure Characteristics and Prediction of Outcome in Usual Clinical Practice.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/0022-006x.73.2.323.
- Williams, Nathaniel J.. 2015. “Assessing Mental Health Clinicians’ Intentions to Adopt Evidence-based Treatments: Reliability and Validity Testing of the Evidence-based Treatment Intentions Scale”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-016-0417-3.
- Steinberg, Alan M., Melissa J. Brymer, Kelly B. Decker, and Robert S. Pynoos. 2004. “The University of California at Los Angeles Post-traumatic Stress Disorder Reaction Index”. Current Psychiatry Reports. Springer Science and Business Media LLC. doi:10.1007/s11920-004-0048-2.
- Chorpita, Bruce F., The Research Network on Youth Mental Health, Alayna Park, Katherine Tsai, Priya Korathu-Larson, Charmaine K. Higa-McMillan, Brad J. Nakamura, John R. Weisz, and Jennifer Krull. 2015. “Balancing Effectiveness with Responsiveness: Therapist Satisfaction Across Different Treatment Designs in the Child Steps Randomized Effectiveness Trial.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0039301.
- Weisz, John R., Rachel A. Vaughn-Coaxum, Spencer C. Evans, Kristel Thomassin, Jacqueline Hersh, Mei Yi Ng, Nancy Lau, Erica H. Lee, Jacquelyn N. Raftery-Helmer, and Patrick Mair. 2019. “Efficient Monitoring of Treatment Response During Youth Psychotherapy: The Behavior and Feelings Survey”. Journal of Clinical Child & Adolescent Psychology. Informa UK Limited. doi:10.1080/15374416.2018.1547973.
- Weisz, John R., The Research Network on Youth Mental Health, Bruce F. Chorpita, Alice Frye, Mei Yi Ng, Nancy Lau, Sarah Kate Bearman, Ana M. Ugueto, David A. Langer, and Kimberly E. Hoagwood. 2011. “Youth Top Problems: Using Idiographic, Consumer-guided Assessment to Identify Treatment Needs and to Track Change During Psychotherapy.”. Journal of Consulting and Clinical Psychology. American Psychological Association (APA). doi:10.1037/a0023307.
- Lawson, Gwendolyn M., Tyler M. Moore, Kelsie H. Okamura, Emily M. Becker-Haimes, and Rinad S. Beidas. 2020. “Knowledge of Evidence-based Services Questionnaire: Development and Validation of a Short Form”. Administration and Policy in Mental Health and Mental Health Services Research. Springer Science and Business Media LLC. doi:10.1007/s10488-020-01020-7.
- Shirk, Stephen R., Marc S. Karver, and Renee Brown. 2011. “The Alliance in Child and Adolescent Psychotherapy.”. Psychotherapy. American Psychological Association (APA). doi:10.1037/a0022181.
- Sheehan, David V., Kathy H. Sheehan, R. Douglas Shytle, Juris Janavs, Yvonne Bannon, Jamison E. Rogers, Karen M. Milo, Saundra L. Stock, and Berney Wilkinson. 2010. “Reliability and Validity of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.09m05305whi.
- Fukui, Sadaaki, Charles A. Rapp, Rick Goscha, Doug Marty, and Mark Ezell. 2013. “The Perceptions of Supervisory Support Scale”. Administration and Policy in Mental Health and Mental Health Services Research. Springer Science and Business Media LLC. doi:10.1007/s10488-013-0470-z.
- 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.
- Institute of Behavioral Research. TCU Organizational Readiness for Change (ORC-D4). Fort Worth: Texas Christian University, Institute of Behavioral Research. 2009.
- Cho, Evelyn, Sarah Kate Bearman, Rebecca Woo, John R. Weisz, and Kristin M. Hawley. 2020. “A Second and Third Look at FIRST: Testing Adaptations of A Principle-guided Youth Psychotherapy”. Journal of Clinical Child & Adolescent Psychology. Informa UK Limited. doi:10.1080/15374416.2020.1796678.
- 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.
- 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. Erratum In: Psychol Assess. 2011 Dec;23(4):969.
- 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.
- John Weisz 2021. "Testing FIRST in Youth Outpatient Psychotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725721.
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