212 Participants Needed

FIRST Psychotherapy for Youth Mental Health Issues

Recruiting at 1 trial location
NL
KR
OP
Overseen ByOlivia Petersen, B.A.
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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment FIRST for youth mental health issues?

The FIRST treatment, tested in community clinics with youths aged 7-15, showed positive results in terms of feasibility, acceptability, and clinical benefit. The study reported improvements in mental health symptoms, with effect sizes ranging from .41 to 2.66, indicating that the treatment was effective in reducing problems identified as important by caregivers and youths.12345

Is FIRST Psychotherapy safe for youth mental health issues?

Research on psychotherapy, including treatments like FIRST, shows that adverse events (unwanted effects) can occur in more than one in ten participants, with serious events happening in more than one in 21 participants. However, the way these events are recorded and reported varies, making it hard to compare results across studies.678910

How is the FIRST treatment different from other treatments for youth mental health issues?

The FIRST treatment is unique because it is a flexible, transdiagnostic approach that uses five key principles to address a range of mental health issues in youth, rather than focusing on a single disorder. This makes it adaptable to the changing needs of young people with multiple mental health challenges.111121314

What is the purpose of this trial?

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
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.

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

🇺🇸
Approved in United States as FIRST for:
  • Anxiety disorders
  • Depressive disorders
  • Conduct-related disorders
🇨🇦
Approved in Canada as FIRST for:
  • Anxiety disorders
  • Depressive disorders
  • Conduct-related disorders

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+

Findings from Research

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]
A study involving 34 clinicians and 22 adolescents in Norway suggests that routine outcome monitoring and clinical feedback systems can enhance psychotherapy for adolescents by focusing on the therapeutic relationship and the therapeutic work.
Participants emphasized the need for a feedback system that is personalized, relationally oriented, and supports collaboration, highlighting the importance of monitoring personal autonomy and the quality of the therapeutic relationship.
This is what I need a clinical feedback system to do for me: A qualitative inquiry into perspectives of adolescents and their therapists.Lavik, KO., Veseth, M., Frøysa, H., et al.[2023]
Despite numerous controlled studies showing the effectiveness of psychotherapy for children and adolescents, research advancements are limited due to inconsistent study methods and a lack of a cohesive research strategy.
To improve treatment outcomes, the article suggests a need for a more systematic approach to research, including better monitoring of treatment implementation and patient progress, as well as expanding the range of research questions and treatment models examined.
A model for developing effective treatments: progression and interplay of theory, research, and practice.Kazdin, AE.[2007]

References

Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents. [2018]
This is what I need a clinical feedback system to do for me: A qualitative inquiry into perspectives of adolescents and their therapists. [2023]
A model for developing effective treatments: progression and interplay of theory, research, and practice. [2007]
An overview of evidence-based psychotherapy for children and adolescents. [2007]
A critical review of psychotherapy outcome studies with adolescents: 1978-1988. [2005]
Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]
Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. [2023]
Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]
[How specific is the evidence base for child and adolescent psychotherapy?]. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]
Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Principle-Guided Psychotherapy for Children and Adolescents (FIRST): Study Protocol for a Randomized Controlled Effectiveness Trial in Outpatient Clinics. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
What Four Decades of Meta-Analysis Have Taught Us About Youth Psychotherapy and the Science of Research Synthesis. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Building Robust Psychotherapies for Children and Adolescents. [2018]
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