FIRST Psychotherapy for Youth Mental Health Issues

Recruiting at 1 trial location

Overseen By Olivia Petersen, B.A.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Harvard University

Disqualifiers: Suicide risk, Eating disorder, Schizophrenia, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 78 weeks

212 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 11 12 13 14}

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

Group I: FIRST Experimental Treatment 1 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 Care Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A model for developing effective treatments: progression and interplay of theory, research, and practice. Kazdin, AE.[2007]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of evidence-based psychotherapy for children and adolescents. Rzepski, B., Jarasek, N.[2007]

Individual psychotherapy for adolescents shows positive short-term outcomes, but the long-term effects are still unclear based on studies from 1978 to 1988.

Systemic therapies, particularly family therapy, demonstrate positive outcomes that tend to be maintained over longer follow-up periods, suggesting their effectiveness in treating adolescent mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical review of psychotherapy outcome studies with adolescents: 1978-1988. Mann, BJ., Borduin, CM.[2005]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

Identifying the specific active components of evidence-based psychotherapies for children and adolescents is crucial for enhancing treatment methods and therapist training, as many effective treatments lack clarity on what makes them work.

Various research methods, including randomized controlled trials and meta-analyses, are essential for uncovering these active ingredients, which will help bridge the gap between individualized care and standardized treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How specific is the evidence base for child and adolescent psychotherapy?]. Goldbeck, L.[2011]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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 improvements in mental health outcomes from FIRST are mediated by the regulation of negative emotions, potentially offering a practical approach to enhance treatment for youths with comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Meta-analyses of over 600 randomized controlled trials have shown that youth psychotherapies are more effective for treating anxiety than depression, highlighting the varying success rates of different mental health interventions.

Despite decades of research, the average benefit of youth psychotherapy has not improved, indicating a need for new strategies and approaches to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Four Decades of Meta-Analysis Have Taught Us About Youth Psychotherapy and the Science of Research Synthesis. Weisz, JR., Venturo-Conerly, KE., Fitzpatrick, OM., et al.[2023]

Empirically supported treatments (ESTs) for children and adolescents have been shown to be more effective than usual care, but the improvement in outcomes is only modest, indicating a need for further refinement.

The current design of many ESTs may not align well with the needs of referred youths in clinical settings, suggesting that a deployment-focused model, which involves developing treatments in real-world contexts, could enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Robust Psychotherapies for Children and Adolescents. Weisz, JR.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

This is what I need a clinical feedback system to do for me: A qualitative inquiry into perspectives of adolescents and their therapists. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A model for developing effective treatments: progression and interplay of theory, research, and practice. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

An overview of evidence-based psychotherapy for children and adolescents. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

A critical review of psychotherapy outcome studies with adolescents: 1978-1988. [2005]

6. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[How specific is the evidence base for child and adolescent psychotherapy?]. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics. [2023]

12. United States pubmed.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 States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Building Robust Psychotherapies for Children and Adolescents. [2018]