212 Participants Needed

FIRST Psychotherapy for Youth Mental Health Issues

Recruiting at 1 trial location
NL
KR
OP
JP
Overseen ByJulie Petersen, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Harvard University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new type of psychotherapy, called FIRST, can assist young people dealing with mental health issues such as anxiety, depression, or conduct problems. FIRST employs five key strategies to manage emotions and improve mental health, and its effects will be compared to standard therapy methods. The trial seeks participants who are fluent in English, aged 7 to 15, and have ongoing issues with anxiety, depression, or behavior. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative mental health therapies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that the FIRST psychotherapy approach is safe for youth?

Research has shown that the FIRST therapy program is generally safe for young people. Studies have found that therapists consider it easy to use and effective, with few reports of problems. No major safety concerns have been identified, and many therapists continue to incorporate it into their practice. FIRST is designed to address issues like anxiety, depression, and behavior problems by teaching skills such as staying calm and solving problems. It has been used successfully in various settings, demonstrating that young patients tolerate it well.12345

Why are researchers excited about this trial?

Researchers are excited about FIRST for youth mental health issues because it offers a fresh approach by focusing on five empirically supported principles of change. Unlike traditional therapies that might target a specific issue, FIRST is versatile and can address a wide range of problems like depression, anxiety, and conduct disorders. This adaptability is crucial for young people whose treatment needs can change during care. Additionally, FIRST uses a unique web-based feedback system to give therapists real-time data on their patients' progress, making it a dynamic and responsive treatment option.

What evidence suggests that this trial's treatments could be effective for youth mental health issues?

Research has shown that FIRST, one of the therapies studied in this trial, holds promise for treating mental health issues such as anxiety, depression, and behavior problems. Studies have found that it employs five main strategies to help children feel calmer, boost motivation, and improve problem-solving skills. In past trials, both young patients and therapists responded well to FIRST, achieving positive results in community mental health settings. The therapy emphasizes helping children manage their emotions, which is crucial for addressing these mental health challenges. Overall, FIRST offers a structured approach to effectively tackle a variety of emotional and behavioral issues in youth.15678

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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
I am between 7 and 15 years old.

Exclusion Criteria

You have an eating disorder, schizophrenia spectrum disorder, autism spectrum disorder, or intellectual disability that requires special education.
You have been referred for ADHD treatment but only for difficulties with paying attention or being hyperactive/impulsive.
You have had thoughts of harming yourself or attempted suicide in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the FIRST transdiagnostic treatment or Usual Care (UC) for mental health issues

78 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months
Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

  • FIRST
  • Usual Care
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: FIRSTExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

FIRST is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as FIRST for:
🇨🇦
Approved in Canada as FIRST for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Harvard University

Lead Sponsor

Trials
237
Recruited
588,000+

University of Texas at Austin

Collaborator

Trials
387
Recruited
86,100+

Published Research Related to This Trial

The FIRST intervention, a flexible transdiagnostic psychotherapy designed for youth with various mental health issues, is being rigorously tested in a randomized controlled trial involving 212 participants aged 7-15, comparing its effectiveness to usual care in community clinics.
This study aims to determine if FIRST improves mental health outcomes by regulating negative emotions and to identify factors that influence how clinicians implement this treatment, potentially making it a practical option for addressing the diverse needs of youths in real-world settings.
Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics.Bailin, A., Cho, E., Sternberg, A., et al.[2023]
The FIRST protocol, a transdiagnostic approach to youth psychotherapy, demonstrated high feasibility and acceptability in community clinics, with 86.6% adherence to the treatment protocol and positive feedback from clients and therapists.
Clinical outcomes showed significant improvements, with effect sizes ranging from 0.41 to 2.66, indicating that the FIRST protocol effectively addresses multiple disorders in youths aged 7-15, justifying further research through a randomized controlled trial.
Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents.Weisz, J., Bearman, SK., Santucci, LC., et al.[2018]
Research over the past 50 years has shifted the understanding of psychotherapy for children, moving from the belief that it was ineffective to recognizing that there are effective treatments for child and adolescent disorders.
The article reviews evidence-based psychotherapies specifically for externalizing and internalizing disorders, while also addressing the challenges of implementing these findings in clinical practice.
An overview of evidence-based psychotherapy for children and adolescents.Rzepski, B., Jarasek, N.[2007]

Citations

CEBC » Program › First A Principal Guided Approach To ...FIRST is a transdiagnostic synthesis of empirically supported treatment procedures for children and adolescents with disorders and problems involving anxiety.
Principle-Guided Psychotherapy for Children and ...This study will evaluate the effectiveness of FIRST in youth community mental health settings, relative to the care usually provided in those settings.
Research Projects | Lab for Youth Mental HealthIn this trial, FIRST scored well (1) on measures of feasibility and acceptability for clients (i.e., youths and caregivers) and clinicians and (2) on clinical ...
Testing Adaptations of A Principle-Guided Youth ...Treatment and Therapist Training​​ FIRST is a principle-guided transdiagnostic approach designed to treat youth anxiety, depression, and behavior problems (Weisz ...
(PDF) Principle-Guided Psychotherapy for Children and ...(PDF) Principle-Guided Psychotherapy for Children and Adolescents (FIRST): Study Protocol for a Randomized Controlled Effectiveness Trial in Outpatient Clinics.
Principle-Guided Psychotherapy for Children and ...This study will evaluate the effectiveness of FIRST in youth community mental health settings, relative to the care usually provided in those settings.
Testing FIRST in Youth Outpatient PsychotherapyFIRST is built upon five empirically supported principles of change (e.g., calming, problem solving), each applicable to treatment of depression, anxiety/OCD, ...
(PDF) Principle-Guided Psychotherapy for Children and ...Study 3 showed high effectiveness ratings, low difficulty ratings, and continued use of FIRST by a majority of clinicians. Conclusions Across ...
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