FIRST Psychotherapy for Youth Mental Health Issues

Recruiting at 1 trial location

Overseen By Julie Petersen, PhD

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

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

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?

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+

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.

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. cebc4cw.org cebc4cw.org/program/first-a-principal-guided-approach-to-evidence-based-youth-psychotherapy/

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10503852/

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.

3. weiszlab.fas.harvard.edu weiszlab.fas.harvard.edu/research-projects

Research Projects | Lab for Youth Mental Health In 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10519126/

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 ...

5. researchgate.net researchgate.net/publication/373770060_Principle-Guided_Psychotherapy_for_Children_and_Adolescents_FIRST_Study_Protocol_for_a_Randomized_Controlled_Effectiveness_Trial_in_Outpatient_Clinics

(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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10589969/

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.

7. reporter.nih.gov reporter.nih.gov/search/p9nVyULFQk-9Gs2rVf2KyQ/project-details/10549743

Testing FIRST in Youth Outpatient Psychotherapy FIRST is built upon five empirically supported principles of change (e.g., calming, problem solving), each applicable to treatment of depression, anxiety/OCD, ...

8. researchgate.net researchgate.net/publication/374898916_Principle-Guided_Psychotherapy_for_Children_and_Adolescents_FIRST_study_protocol_for_a_randomized_controlled_effectiveness_trial_in_outpatient_clinics

(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 ...