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Behavioral Intervention

FIRST Psychotherapy for Youth Mental Health Issues

N/A
Recruiting
Research Sponsored by Harvard University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ages 7.0-15.9 years
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed throughout treatment via observational coding (ongoing from 0 up to 78 weeks)
Awards & highlights

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.

Who is the study for?
This trial is for children aged 7 to almost 16 who show signs of anxiety, depression, conduct issues, or post-traumatic stress but are generally in English-speaking classes. It's not for kids at immediate suicide risk, with eating disorders, schizophrenia-related conditions, autism spectrum disorder, intellectual disabilities needing special school classes or those referred only for ADHD symptoms.Check my eligibility
What is being tested?
The study tests FIRST—a therapy based on five proven principles—against the usual care given to young people with mental health challenges. The focus is on how well each treatment improves mental health and helps manage negative emotions.See study design
What are the potential side effects?
Since this trial involves psychotherapy rather than medication, side effects may include emotional discomfort during sessions and potential increases in distress as difficult topics are discussed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 7 and 15 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavior and Feelings Survey (BFS; Weisz et al., 2020)
Child Behavior Checklist (CBCL; Achenbach & Rescorla, 2001) and Youth Self-Report (YSR; Achenbach & Rescorla, 2001)
Functional Top Problems Assessment (TPA; Weisz et al., 2011)
Secondary outcome measures
Coping Questionnaire (CQ; Crane & Kendall, 2020)
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID parent version; Sheehan et al., 2010)
Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al., 1999; Ebesutani et al., 2011)
+1 more
Other outcome measures
Engagement of families in treatment
Evidence-Based Practice Attitudes Scale (EBPAS-15; Aarons, 2004)
Evidence-Based Treatment Intentions (EBTI; Williams, 2015)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FIRSTExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
Treatment in the usual care (UC) condition will use the clinical procedures therapists consider appropriate and believe to be effective.

Find a Location

Who is running the clinical trial?

Harvard UniversityLead Sponsor
232 Previous Clinical Trials
474,883 Total Patients Enrolled
26 Trials studying Depression
9,706 Patients Enrolled for Depression
University of Texas at AustinOTHER
359 Previous Clinical Trials
81,541 Total Patients Enrolled
31 Trials studying Depression
5,077 Patients Enrolled for Depression

Media Library

FIRST (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04725721 — N/A
Depression Research Study Groups: FIRST, Usual Care
Depression Clinical Trial 2023: FIRST Highlights & Side Effects. Trial Name: NCT04725721 — N/A
FIRST (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725721 — N/A
~73 spots leftby Feb 2026
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