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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 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)
Awards & highlights

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.

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 ~monthly beginning after first session through end of treatment (every 4 weeks from 0 up to 78 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly beginning after first session through end of treatment (every 4 weeks 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
229 Previous Clinical Trials
474,371 Total Patients Enrolled
26 Trials studying Depression
9,706 Patients Enrolled for Depression
University of Texas at AustinOTHER
350 Previous Clinical Trials
80,772 Total Patients Enrolled
30 Trials studying Depression
5,067 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify to partake in this medical research?

"The trial is taking on 212 participants aged 7-15 years old diagnosed with depression. To be eligible, they must also have a clinically significant score in any CBCL subscale: including but not limited to anxiety, PTSD, conduct issues and melancholy."

Answered by AI

Is the age cutoff for this medical experiment restricted to those younger than sixty years old?

"For this medical trial, the eligibility criteria requires that participants must be between 7 and 15 years old. Clinicialtrials.gov has registered 278 studies for individuals in the under 18 age category, while 1090 are available to those over 65."

Answered by AI

How many patients are partaking in this clinical endeavor?

"Affirmative. As indicated on clinicaltrials.gov, this medical experiment is actively recruiting participants with recruitment beginning on September 27th 2021 and the details most recently updated October 8th 2021. 212 patients must be sourced from 2 research sites for the study to proceed."

Answered by AI

Are there any open opportunities for volunteers to join this research endeavor?

"Yes, the records on clinicaltrials.gov affirm that this scientific investigation is presently enrolling participants. It was initially made available on September 27th 2021 and most recently updated October 8th 2021 - with an aim to recruit a total of 212 individuals from 2 locations."

Answered by AI

What is the purpose of this research project?

"This trial seeks to analyze the Functional Top Problems Assessment (TPA; Weisz et al., 2011) over a 0-78 week period, while also measuring secondary outcomes like Positive and Negative Affect Schedule Short Form (PANAS-C/P-SF; Laurent et al. 1999; Ebesutani et al. 2011), UCLA PTSD Reaction Index (PTSDRI; Steinberg et al. 2004), and Coping Questionnaire (CQ; Crane & Kendall 2020). The PANAS includes 5 emotion descriptors for positive affections such as joyfulness and pride, along with 5 for negative emotions including distress and"

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas at Austin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~86 spots leftby Feb 2026