Digital Single Session Intervention for Youth Mental Health
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Harvard University
Disqualifiers: Non-English speaking, No digital device
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests an online program for kids aged 9-17 who are waiting for mental health treatment. The program teaches them to change negative behaviors by practicing positive ones, helping them feel better while they wait for therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but it's best to confirm with the trial organizers.
What data supports the effectiveness of the treatment Practicing the Opposite (PTO) for youth mental health?
Research shows that digital health interventions and behavioral programs can effectively reduce mental health problems in youth. Programs targeting early signs of issues, like those using behavioral techniques, have been found to significantly improve outcomes, suggesting that similar approaches like PTO could be beneficial.
12345Is the Digital Single Session Intervention for Youth Mental Health safe for children and adolescents?
There is limited information on the safety of psychological therapies for children and adolescents, and adverse effects (unintended negative outcomes) are not well-defined or consistently reported. Practitioners note that children may be particularly vulnerable to adverse effects, which can include emotional, behavioral, and social consequences.
678910What makes the Practicing the Opposite (PTO) treatment unique for youth mental health?
Practicing the Opposite (PTO) is unique because it is a digital single-session intervention, meaning it is designed to be completed in just one session, making it more accessible and cost-effective compared to traditional, longer-term therapies. This approach can quickly reach a large number of youths, especially those who might not otherwise seek help, and is particularly useful during times when in-person therapy is less accessible, such as during the Covid-19 pandemic.
211121314Eligibility Criteria
This trial is for English-speaking youths aged 9-17 in the Boston area who are on a waitlist for mental health care. They must have access to a digital device, be able to read English well enough to complete digital programs, and have consent from at least one guardian.Inclusion Criteria
Youth and at least one guardian consent to the youth's participation in study
Youth has access to a digital device
I am between 9 and 17 years old.
+2 more
Exclusion Criteria
I do not have a smartphone, computer, or tablet.
I do not speak English.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Participants receive a single-session, digital intervention teaching the principle of practicing the opposite
30-45 minutes
1 session (online)
Follow-up
Participants are monitored for changes in mental health outcomes post-intervention
1 month
Post-intervention, 2-week, and 1-month follow-up assessments
Long-term Follow-up
Participants' mental health outcomes are tracked until completion of clinic treatment or 1 year
Up to 1 year
Participant Groups
The study tests 'Practicing the Opposite' (PTO), a single-session digital intervention aimed at improving youth mental health against usual waitlist procedures. It's designed for those awaiting psychotherapy.
2Treatment groups
Experimental Treatment
Group I: Usual waitlist control groupExperimental Treatment1 Intervention
Usual waitlist procedures involve watchful waiting for a therapist to become available, sometimes complemented by periodic check-ins from the family with clinic administrators. After being removed from the waitlist and contacted to begin treatment, participants in both study conditions will receive treatment as usual in the clinic.
Group II: Practicing the Opposite (PTO) interventionExperimental Treatment1 Intervention
This 30-45 minutes Qualtrics-based, digital program uses stories, interactive activities, and engaging graphics to teach youths one core principle: by practicing the positive opposite of unhelpful behaviors (e.g., engaging with rather than avoiding feared stimuli), one can, over time, change their mood, thoughts, and actions. The intervention is comprised of four main sections: 1) An introduction to PTO; (2) Testimonials from young people who have been helped by PTO; (3) Learning how to Practice the Opposite through online activities. (4) Planning how to continue to Practice the Opposite in the participant's life. Of note, after being removed from the waitlist at the clinic and contacted to begin treatment, participants will still receive treatment as usual from the clinic.
Practicing the Opposite (PTO) is already approved in United States, Canada for the following indications:
🇺🇸 Approved in United States as Practicing the Opposite for:
- Youth mental health issues such as anxiety, depression, and hopelessness
🇨🇦 Approved in Canada as Practicing the Opposite for:
- Youth mental health issues such as anxiety, depression, and hopelessness
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Concord CenterConcord, MA
Riley Child Psychiatry and Behavioral Sciences ClinicIndianapolis, IN
The Baker Center for Children and FamiliesBoston, MA
Boston Child Study CenterBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Harvard UniversityLead Sponsor
References
Harnessing Wise Interventions to Advance the Potency and Reach of Youth Mental Health Services. [2021]Despite progress in research on evidence-based treatments (EBTs) for youth psychopathology, many youths with mental health needs do not receive services, and EBTs are not always effective for those who access them. Wise interventions (WIs) may help address needs for more disseminable, potent youth mental health interventions. WIs are single-component, social-psychological interventions designed to foster adaptive meaning-making. They have improved health-related and interpersonal youth outcomes, yet their potential to reduce youth psychopathology has not been systematically explored. Accordingly, we conducted a systematic, descriptive review characterizing WIs' potential to reduce youth mental health problems. Across 25 RCTs (N = 9219 youths, ages 11-19) testing 13 intervention types, 7 WIs qualified as "Well-Established," "Probably Efficacious," or "Possibly Efficacious" for reducing one or more types of youth psychopathology, relative to controls. Among these, 5 WIs significantly reduced youth depressive symptoms; 3, general psychological distress; and 1 each, eating problems, anxiety, and substance use. Three of these 7 WIs were self-administered by youths, and four by trained interventionists; collectively, they were 30-168 min in length and targeted clinic-referred and non-referred samples in clinical, school, and laboratory settings. Overall, certain WIs show promise in reducing mild-to-severe youth psychopathology. Given their brevity and low cost relative to traditional (i.e., therapist-delivered, 12- to 16-week, clinic-based) EBTs, WIs may represent beneficial additions to the youth mental healthcare ecosystem. Priorities for future research are proposed, including testing WIs for parents, younger children, and externalizing problems; as EBT adjuncts; and in schools and primary care clinics to increase access to brief, effective supports.
Mechanisms of Change in Digital Health Interventions for Mental Disorders in Youth: Systematic Review. [2021]Digital health interventions (DHIs) are efficacious for several mental disorders in youth; however, integrated, evidence-based knowledge about the mechanisms of change in these interventions is lacking.
Evaluation of indicated preventive intervention (secondary prevention) mental health programs for children and adolescents. [2019]Evaluated the outcomes of 130 indicated preventive interventions (secondary prevention) mental health programs for children and adolescents that seek to identify early signs of maladjustment and to intervene before full-blown disorders develop. Results indicate such programs significantly reduce problems and significantly increase competencies. In particular, behavioral and cognitive-behavior programs for children with subclinical disorders (mean ESs in the 0.50s) appear as effective as psychotherapy for children with established problems and more effective than attempts to prevent adolescent smoking alcohol use, and delinquency. In practical terms, the average participant receiving behavioral or cognitive-behavior intervention surpasses the performance of approximately 70% of those in a control group. Of particular interest was the high mean effect (0.72) achieved by programs targeting incipient externalizing problems which are customarily the least amenable to change via traditional psychotherapeutic efforts when they reach clinical levels. Priorities for future research include greater specification of intervention procedures, assessment of treatment implementation, more follow-up studies, and identifying how different participants respond to early intervention.
Outcome Orientated Child and Adolescent Mental Health Services (OO-CAMHS): a whole service model. [2019]The international evidence base on factors that most influence outcomes in mental health care finds that matching therapeutic intervention to diagnosis has a clinically insignificant impact on outcomes. Decades of outcome research into treatment of psychiatric disorders shows that, despite the development of many new techniques, the outcomes being achieved in studies 30 years ago are similar to those being achieved now. In the last few years, new service models that incorporate systems of feedback on progress and alliance have emerged and show promise with regards improving overall outcomes for mental health service users. Growing familiarity with this outcome literature, together with a desire to be part of a service that can continue to improve patient outcomes, led a small community Child and Adolescent Mental Health Services team to develop a new whole service model - Outcome Orientated Child and Adolescent Mental Health Services (OO-CAMHS). OO-CAMHS incorporates key aspects of the evidence base on what could make a differential positive impact on outcomes and relinquishes those aspects that do not. In this paper, we outline the evidence base on which OO-CAMHS is built, describe the key features of the approach and present some of the early findings on its impact.
Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment. [2021]The quality of child mental health care is highly variable in community practice settings. Innovative technology-based solutions may be leveraged to improve quality of care and, in turn, treatment outcomes. This is a protocol paper that describes an innovative study design in which we rigorously evaluate the effectiveness of a tablet-assisted intervention, Supporting Providers and Reaching Kids (SPARK). SPARK consists of a collection of interactive games and activities that are designed to improve provider fidelity and child engagement in evidence-based psychotherapies. The methodology also allows us to explore the implementation and sustainability of a technology-enhanced intervention in more than two dozen community practice settings. This paper includes a description and justification for sample selection and recruitment procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Novel features of the design include the tablet-based toolkit approach that has strong applicability to a range of child mental health interventions and the use of a hybrid type 1 effectiveness-implementation trial that allows for the simultaneous investigation of the effectiveness of the intervention and the implementation context. Challenges related to the implementation of a technology-enhanced intervention in existing mental health clinics are discussed, as well as implications for future research and practice.
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.
Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]Adverse Events (AEs) are defined as any unfavorable and unintended sign or symptom, that may occur during or after receipt of any intervention. The principle of non-maleficence requires careful consideration to ensure that existing or new psychological interventions are not harmful before they can be considered beneficial. In this context, the safety of psychological interventions, including the possible occurrence of AEs, is increasingly important for patients, families, and clinicians. The evaluation of AEs is crucial to obtain a complete understanding of the risk/benefit balance of psychological interventions. There is a need for researchers and clinicians to assess and report AEs comprehensively and in a coordinated manner. It is necessary to have more accurate data on the recording of AEs in protocols to enhance transparency and consistency, as well as to improve practice. Finally, and to facilitate this process, there is a need for standards for data collection.
Significant differences in pediatric psychotropic side effects: Implications for school performance. [2019]Some side effects (SEs) of increasingly prescribed psychotropic medications can impact student performance in school. SE risk varies, even among drugs from the same class (e.g., antidepressants). Knowing which SEs occur significantly more often than others may enable school psychologists to enhance collaborative risk-benefit analysis, medication monitoring, data-based decision-making, and inform mitigation efforts. SE data from Full Prescribing Information (PI) on the FDA website for ADHD drugs, atypical antipsychotics, and antidepressants with pediatric indications were analyzed. Risk ratios (RR) are reported for each drug within a category compared with placebo. RR tables and graphs inform the reader about SE incidence differences for each drug and provide clear evidence of the wide variability in SE incidence in the FDA data. Breslow-Day and Cochran Mantel-Haenszel methods were used to test for drug-placebo SE differences and to test for significance across drugs within each category based on odds ratios (ORs). Significant drug-placebo differences were found for each drug compared with placebo, when odds were pooled across all drugs in a category compared with placebo, and between some drugs within categories. Unexpectedly, many large RR differences did not reach significance. Potential explanations are offered, including limitations of the FDA data sets and statistical and methodological issues. Future research directions are offered. The potential impact of certain SEs on school performance, mitigation strategies, and the potential role of the school psychologist is discussed, with consideration for ethical and legal limitations.
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods.
Adverse effects of psychological therapy: An exploratory study of practitioners' experiences from child and adolescent psychiatry. [2022]The scientific knowledge about adverse effects of psychological therapies and how such effects should be detected is limited. It is possible that children and adolescents are particularly vulnerable and need specific support in order to express adverse effects. In this exploratory study, we used a qualitative approach to explore practitioners' experiences of this phenomenon. Fourteen practitioners providing psychological therapy within the Child and Adolescent Psychiatric Service were interviewed. Qualitative content analysis was applied to the data. Four overarching categories brought up by the practitioners were identified: vagueness of the concept (reflecting that the concept was novel and hard to define), psychotherapist-client interaction (encompassing aspects of the interaction possibly related to adverse effects), consequences for the young person (including a range of emotional, behavioural and social consequences) and family effects (e.g. professional complications and decreased autonomy for the parent). Professional discussions on these issues could improve psychological therapy for children and adolescents. Based on our findings and previous research, we propose three basic aspects to consider when adverse effects are detected and managed in this context: typology (form, severity and duration), aetiology (hypothesis about the causes) and perspective (adverse effects seen from the points of view of different interested parties).
ENgage YOung people earlY (ENYOY): a mixed-method study design for a digital transdiagnostic clinical - and peer- moderated treatment platform for youth with beginning mental health complaints in the Netherlands. [2021]The onset of mental disorders typically occurs between the ages of 12 and 25, and the burden of mental health problems is the most consequential for this group. Indicated prevention interventions to target individuals with subclinical symptoms to prevent the transition to clinical levels of disorders, even leading to suicide, have shown to be effective. However, the threshold to seek help appears to be high. Digital interventions could offer a solution, especially during the Covid-19 pandemic. This implementation study will investigate the digital indicated prevention intervention ENgage YOung people Early (ENYOY), the Dutch version of the original Moderated Online Social Therapy Platform (MOST+) from Australia. In addition, the relationship between stress biomarkers, symptoms and outcome measures of youth using the platform will be investigated in this study.
Evaluating a treatment selection approach for online single-session interventions for adolescent depression. [2023]The question 'what works for whom' is essential to mental health research, as matching individuals to the treatment best suited to their needs has the potential to maximize the effectiveness of existing approaches. Digitally administered single-session interventions (SSIs) are effective means of reducing depressive symptoms in adolescence, with potential for rapid, large-scale implementation. However, little is known about which SSIs work best for different adolescents.
Harnessing single-session interventions to improve adolescent mental health and well-being in India: Development, adaptation, and pilot testing of online single-session interventions in Indian secondary schools. [2021]Many evidence-based prevention and intervention approaches for youth mental health exist, but most are time-consuming and expensive to deliver. Innovative approaches are needed to develop and disseminate scalable mental health interventions, especially for youth in low- and middle-income countries. Computerized single-session interventions (SSIs) may be able to overcome many of these implementation barriers, especially if deployed in school settings.
Future Directions in Single-Session Youth Mental Health Interventions. [2023]The United States spends more money on mental health services than any other country, yet access to effective psychological services remains strikingly low. The need-to-access gap is especially wide among children and adolescents, with up to 80% of youths with mental health needs going without services, and the remainder often receiving insufficient or untested care. Single-session interventions (SSIs) may offer a promising path toward improving accessibility, cost-effectiveness, and completion rates for youth mental health services. SSIs are structured programs that intentionally involve only one visit or encounter with a clinic, provider, or program; they may serve as stand-alone or adjunctive clinical services. A growing body of evidence supports the capacity of SSIs to reduce and prevent youth psychopathology of multiple types. Here, we provide a working definition of SSIs for use in future research and practice; summarize the literature to date on SSIs for child and adolescent mental health; and propose recommendations for the future design, evaluation, and implementation of SSIs across a variety of settings and contexts. We hope that this paper will serve as an actionable research agenda for gauging the full potential of SSIs as a force for youth mental health.