FIRST for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Depression+3 MoreFIRST - Behavioral
Eligibility
7 - 15
All Sexes
What conditions do you have?
Select

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: Behavioral
Usual Care
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Behavioral

Trial 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