Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Harvard University
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
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.
Is the FIRST treatment a promising option for youth mental health issues?Yes, the FIRST treatment is promising for youth mental health issues. It is flexible and can address multiple problems at once, which is helpful for young people with different or changing needs. It has shown positive results in improving mental health in several trials and is designed to be easy for therapists to use in real-world settings.6791213
What safety data exists for FIRST psychotherapy for youth mental health issues?The safety data for FIRST psychotherapy, like other psychosocial interventions for youth, is limited and not consistently reported. Systematic reviews indicate that adverse events (AEs) in psychotherapy are often not clearly defined or monitored, and reporting is inconsistent across studies. While some studies report AEs, the association with the treatment is often unclear. Serious AEs occur in more than one in 21 participants in psychotherapy trials, but comprehensive harm monitoring is not standard practice. Therefore, more systematic and expanded monitoring of AEs is needed to better understand the risks and benefits of psychotherapy interventions like FIRST.45101114
What data supports the idea that FIRST Psychotherapy for Youth Mental Health Issues is an effective treatment?The available research shows that FIRST Psychotherapy is effective for treating youth mental health issues. In a study involving 24 young people aged 7-15, the treatment was found to be feasible and well-accepted by both clients and therapists. The study reported improvements in the participants' mental health problems, with scores indicating clinical improvement. These improvements were as good as or better than those seen in other similar treatments. The study also noted that therapists were able to follow the treatment protocol well, which contributed to its success.12378
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
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
I am between 7 and 15 years old.
Treatment Details
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.
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
Research locations nearbySelect from list below to view details:
Harvard UniversityCambridge, MA
University of Texas at AustinAustin, TX
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Who is running the clinical trial?
Harvard UniversityLead Sponsor
University of Texas at AustinCollaborator
References
A critical review of psychotherapy outcome studies with adolescents: 1978-1988. [2005]Although interest in identifying effective psychotherapies for adolescent mental health problems has increased dramatically in the last decade, there have been few attempts to summarize and integrate the recent empirical literature on psychotherapy outcomes with adolescents. The present paper reviews the methods and findings of adolescent psychotherapy outcome studies published from 1978 to 1988. Evaluations of individual psychotherapy with adolescents generally reveal positive short-term outcomes, but long-term outcomes are still to be determined. Evaluations of systemic therapies (especially family therapy) with adolescents often reveal positive outcomes that are maintained over extended follow-up periods. Recommendations are presented for improving the methodology of future psychotherapy outcome studies with adolescents.
A model for developing effective treatments: progression and interplay of theory, research, and practice. [2007]The central thesis of this article is that advances in psychotherapy research for children and adolescents are limited, despite the large number of controlled studies and consistent conclusions about demonstrated effectiveness. The ways in which individual studies are conducted and the lack of an overall plan for the progression of research to identify effective treatments have contributed to the limited conclusions. In this article, I identify steps toward developing effective treatment that entail conceptualization and investigation of clinical problems, processes of change, and conditions that influence treatment outcome. Progress will not only require more systematic accretion of research, but also expansion in the range of questions, outcomes, and models of treatment delivery that are examined. Efforts to improve the knowledge base and to integrate knowledge into clinical practice can also be greatly enhanced by modifying the ways in which clinical work is conducted and specifically by systematically monitoring treatment implementation and patient progress.
An overview of evidence-based psychotherapy for children and adolescents. [2007]Research on psychotherapy outcomes, particularly with children, has a short but evolving history. Studies in the 1950s and 1960s suggested therapy was no more useful than no treatment and the passage of time. There were many flaws in the research upon which this conclusion of no improvement from psychotherapy was based and it has taken the next half century to generate more studies and to reconsider the evidence for efficacy of psychotherapy. While problems continue to exist with the quantity, strength, and generalizability of research on child psychotherapies, it is increasingly accepted that efficacious treatments do exist for child and adolescent disorders. This article provides an overview of evidence-based psychotherapies for the two chief domains of psychiatric problems in children and adolescents: externalizing and internalizing disorders. The concurrent challenge of integrating research findings into typical treatment settings and promoting their adoption with clinical practitioners will be highlighted.
[How specific is the evidence base for child and adolescent psychotherapy?]. [2011]Evidence-based psychotherapy (EBP) proposes the fit between a specific treatment, therapist, patient and mental disorder. At the same time, the generalization of psychotherapy research findings is intended. In this conflict between individualized and standardized treatment the search for specific active components of psychotherapy is essential to improve intervention methods as well as training of therapists. Many manualized treatments for children and adolescents are considered evidence-based, proven by its outcome. However, their active ingredients often remain unclear. The following methods to identify necessary active components for successful treatments are described: classical comparative randomized controlled trials, dismantling studies, add-on studies, meta-analyses, and the multiphase optimization strategy. Consequences for the future agenda for child and adolescent psychotherapy research are discussed.
The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]Monitoring for possible adverse events is ethically required by Institutional Review Boards and Good Clinical Practice guidelines for all human research involving the delivery of treatment interventions in a clinical trial. The monitoring of adverse events is a well-established and routine practice for contemporary clinical trials involving medications and medical devices. However, these same guidelines have not been fully integrated into clinical trials involving the use of behavioral health interventions and psychotherapy. Most behavioral health clinical trials limit adverse event monitoring to serious adverse events such as suicide attempts, completed suicides, and psychiatric hospitalizations. Other possible "side effects" of psychotherapy, such as temporary increases in anxiety, are often considered a normal part of therapy and are therefore not documented as possible adverse events. This manuscript reviews a variety of reasons for the limited adverse event monitoring in behavioral health clinical trials and highlights the importance of incorporating expanded adverse event monitoring into future behavioral health clinical trials. Without understanding the nature and prevalence of adverse events, patients cannot be informed adequately of the possible risks and benefits of behavioral interventions prior to engaging in treatment.
Building Robust Psychotherapies for Children and Adolescents. [2018]Psychotherapies for children and adolescents have been tested in hundreds of randomized controlled trials across five decades, and many of these youth therapies have now been classified as empirically supported treatments (ESTs). A burgeoning movement is underway to implement these ESTs in clinical practice settings, but questions arise as to whether the treatments are ready for practice and whether they will improve outcomes for clinically referred youths. Our data show ESTs to be more effective than usual care, on average, but only modestly so, and there are troubling exceptions. One reason may be that the design of most ESTs (e.g., single-disorder focus, linear session sequence) does not fit the characteristics of referred youths or clinical practice very well. Indeed, youth psychotherapy research has not focused much on the clients or contexts of actual clinical care. An alternative empirical approach, the deployment-focused model, proposes developing and testing interventions with the clients, clinicians, and contexts for which they are ultimately intended. Recent application of the model highlights its potential for stimulating robust treatments that are effective in clinical practice.
Initial Test of a Principle-Guided Approach to Transdiagnostic Psychotherapy With Children and Adolescents. [2018]To address implementation challenges faced by some evidence-based youth psychotherapies, we developed an efficient transdiagnostic approach-a potential "first course" in evidence-based treatment (EBP)-guided by five empirically supported principles of therapeutic change. An open trial of the resulting FIRST protocol was conducted in community clinics. Following a 2-day training, staff practitioners treated 24 clinically referred youths ages 7-15, 50% male, 87% White and 13% Latino, all with the Schedule for Affective Disorders and Schizophrenia for School-Age Children Diagnostic and Statistical Manual of Mental Disorders (4th ed.) anxiety, depressive, or conduct-related disorders, and averaging 2.21 disorders. We evaluated the protocol's (a) feasibility for use in everyday clinical practice (examining therapy process, client engagement, and therapist adherence and competence in using the protocol), (b) acceptability (examining therapeutic alliance and treatment satisfaction by youths, caregivers, and therapists), and (c) potential for clinical benefit (examining treatment outcomes across multiple measures and time points). FIRST scored well on measures of feasibility, acceptability to clients and clinicians, and clinical outcomes, matching or exceeding the corresponding scores in most benchmarking comparisons. Observational coding of sessions showed high levels of protocol adherence (86.6%) and good therapist competence in the evidence-based skills. Weekly assessments throughout treatment showed effect sizes for clinical improvement ranging from .41 to 2.66 on weekly total problems and problems deemed "most important" by caregivers and youths. The FIRST protocol showed evidence of feasibility, acceptability, and clinical benefit when used by practitioners with referred youths treated in community clinics. The findings suggest sufficient potential to justify a full randomized controlled trial of FIRST.
This is what I need a clinical feedback system to do for me: A qualitative inquiry into perspectives of adolescents and their therapists. [2023]Routine outcome monitoring and clinical feedback systems might be beneficial for adolescent psychotherapy processes.
What Four Decades of Meta-Analysis Have Taught Us About Youth Psychotherapy and the Science of Research Synthesis. [2023]Intervention scientists have published more than 600 randomized controlled trials (RCTs) of youth psychotherapies. Four decades of meta-analyses have been used to synthesize the RCT findings and identify scientifically and clinically significant patterns. These meta-analyses have limitations, noted herein, but they have advanced our understanding of youth psychotherapy, revealing (a) mental health problems for which our interventions are more and less successful (e.g., anxiety and depression, respectively); (b) the beneficial effects of single-session interventions, interventions delivered remotely, and interventions tested in low- and middle-income countries; (c) the association of societal sexism and racism with reduced treatment benefit in majority-girl and majority-Black groups; and, importantly, (d) the finding that average youth treatment benefit has not increased across five decades of research, suggesting that new strategies may be needed. Opportunities for the future include boosting relevance to policy and practice and using meta-analysis to identify mechanisms of change and guide personalizing of treatment.
Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.
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]Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD.
Principle-Guided Psychotherapy for Children and Adolescents (FIRST): Study Protocol for a Randomized Controlled Effectiveness Trial in Outpatient Clinics. [2023]Hundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder or homogeneous cluster of problems may not be ideal for clinically referred youths who have comorbidity and whose treatment needs may shift from week to week. This concern has prompted development of flexible transdiagnostic, modular youth psychotherapies. One of these, designed for efficient training and implementation, is FIRST-a transdiagnostic intervention built on five empirically supported principles of change (i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, and trying the opposite) and targeting common internalizing and externalizing youth mental health disorders and problems. FIRST has shown promise in improving youth mental health in three open trials. Now, in a more rigorous test, we seek to (1) conduct a randomized controlled trial comparing FIRST to usual care in real-world clinical practice settings; (2) examine a promising candidate mediator of change-regulation of negative emotions; and (3) explore variables that may influence clinicians' treatment implementation.
Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics. [2023]Hundreds of youth psychotherapy randomized trials have generated scores of helpful empirically supported treatments (ESTs). However, the standardized structure of many ESTs and their focus on a single disorder or homogeneous cluster of problems may not be ideal for clinically referred youths who have comorbidity and whose treatment needs may shift from week to week. This concern has prompted development of flexible transdiagnostic, modular youth psychotherapies. One of these, designed for efficient training and implementation, is FIRST-a transdiagnostic intervention built on five empirically supported principles of change (i.e., feeling calm, increasing motivation, repairing thoughts, solving problems, and trying the opposite) and targeting common internalizing and externalizing youth mental health disorders and problems. FIRST has shown promise in improving youth mental health in three open trials. Now, in a more rigorous test, we seek to (1) conduct a randomized controlled trial comparing FIRST to usual care in real-world clinical practice settings; (2) examine a promising candidate mediator of change-regulation of negative emotions; and (3) explore variables that may influence clinicians' treatment implementation.
Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]Objective: Although evidence for benefits of psychotherapy is substantial, less is known about potential harm. Therefore, we systematically summarized randomized controlled trials (RCTs) to compile evidence-based data on the frequency and characteristics of adverse events (AEs) of psychotherapy. Method: This systematic review of result publications is based on a review of harm consideration in psychotherapy study protocols. Results: On the basis of 115 study protocols, 85 RCTs with 126 psychotherapy and 61 control conditions were eligible for inclusion. The sample consisted of 14,420 participants with the most common mental disorders. Harmful events, e.g., AEs, number of individuals with symptom deterioration, were explicitly reported in 60% of the studies. Conceptualization, recording, and reporting of AEs were heterogeneous. For most reported AEs, the association to study treatment remained unclear. Conclusions: Because the AE recording approaches of the individual studies differed substantially, results could only be compared to a limited extent. Consistent with other findings, this review demonstrates that AEs can be expected to affect more than one in ten participants. Serious AEs occurred more than in one in 21 participants in psychotherapy RCTs. To allow a balanced risk/benefit evaluation of psychotherapy, systematic harm monitoring and reporting should become standard in psychotherapy RCTs.