Digital Single Session Intervention for Youth Mental Health

Recruiting at 4 trial locations

Overseen By Katherine Venturo-Conerly, A.M.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Harvard University

Disqualifiers: Non-English speaking, No digital device

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: 3

226 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital program designed to help young people feel better while waiting for mental health therapy. The program teaches "Practicing the Opposite" (PTO), a technique that encourages kids to try positive actions instead of negative ones to improve mood and behavior. It includes a brief, online session with stories and activities to make learning engaging. This trial suits English-speaking youths aged 9-17 who have contacted a clinic for mental health care and have access to a digital device. As an unphased trial, it offers participants a unique opportunity to contribute to innovative mental health solutions for young people.

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 prior data suggests that this digital intervention is safe for youth mental health?

Research has shown that the "Practicing the Opposite" (PTO) technique is generally safe for mental health care. Some studies have examined its effectiveness and found that it helps people manage emotions by encouraging them to face fears rather than avoid them. This method originates from Dialectical Behavior Therapy (DBT), which often aids in emotional control.

Regarding safety, little evidence suggests major negative effects from PTO. Since it focuses on behavior change rather than medication, it typically has fewer side effects. Participants engage in activities and stories that teach positive behaviors, which are considered low-risk.

The PTO method in this study is digital and involves just one session, further reducing the likelihood of safety issues. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Practicing the Opposite" (PTO) technique because it offers a fresh approach to youth mental health by focusing on changing behaviors through digital means. Unlike traditional therapies that often require in-person sessions and can involve long waits, PTO is a quick, 30-45 minute online intervention accessible anytime. It empowers young people to actively transform their mood and actions by practicing positive behaviors in place of negative ones, using stories and interactive activities. This self-directed digital format not only makes mental health support more accessible but also provides tools for immediate and ongoing personal development.

What evidence suggests that the Practicing the Opposite intervention could be effective for youth mental health?

Research shows that the "Practicing the Opposite" (PTO) approach, which participants in this trial may receive, can improve mental health in young people. This method draws from a dialectical behavior therapy (DBT) technique called "opposite action," which encourages positive behaviors to manage emotions. Studies have found that online programs like PTO assist young people with mental health challenges by teaching them to change their mood, thoughts, and actions through fun activities. Early results suggest that this digital method is both easy to access and effective in helping teens manage difficult emotions better. ^{2 6 7 8 9}

Who Is on the Research Team?

Katherine Venturo-Conerly, A.B.

Principal Investigator

Harvard University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I do not have a smartphone, computer, or tablet.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Practicing the Opposite (PTO)
• Usual Clinical Care

Trial Overview

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.

How Is the Trial Designed?

Group I: Usual waitlist control group Experimental Treatment 1 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) intervention Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Harvard University

Lead Sponsor

Trials

237

Recruited

588,000+

Published Research Related to This Trial

A systematic review of 25 randomized controlled trials involving 9219 youths (ages 11-19) found that certain wise interventions (WIs) can effectively reduce youth mental health issues, with 7 interventions classified as 'Well-Established' or 'Probably Efficacious.'

Among these effective WIs, 5 significantly reduced depressive symptoms, and they are relatively brief and low-cost compared to traditional therapies, suggesting they could enhance access to mental health support for youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing Wise Interventions to Advance the Potency and Reach of Youth Mental Health Services. Schleider, JL., Mullarkey, MC., Chacko, A.[2021]

This systematic review analyzed 25 studies on digital health interventions (DHIs) for mental disorders in youth, identifying cognitive and affective mediators as key factors influencing intervention outcomes, with 100% of affective mediators showing significant effects.

Despite the promising findings, most studies lacked the ability to draw causal conclusions, highlighting the need for improved research designs to better understand how DHIs work and enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Change in Digital Health Interventions for Mental Disorders in Youth: Systematic Review. Domhardt, M., Engler, S., Nowak, H., et al.[2021]

Preventive mental health programs for children and adolescents significantly reduce behavioral problems and enhance competencies, with behavioral and cognitive-behavioral interventions showing effect sizes around 0.50, comparable to traditional psychotherapy.

Programs targeting early signs of externalizing problems achieved a high mean effect size of 0.72, indicating they are particularly effective at preventing the escalation of issues that are typically resistant to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of indicated preventive intervention (secondary prevention) mental health programs for children and adolescents. Durlak, JA., Wells, AM.[2019]

The SPARK intervention, which uses tablet-assisted interactive games and activities, aims to enhance provider fidelity and child engagement in evidence-based psychotherapies, potentially improving the quality of mental health care for children.

This study employs a hybrid effectiveness-implementation trial design across over two dozen community practice settings, allowing researchers to evaluate both the effectiveness of the SPARK intervention and the challenges of implementing technology in existing mental health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment. Anton, MT., Ridings, LE., Hanson, R., et al.[2021]

The ENgage YOung people Early (ENYOY) digital intervention aims to provide accessible mental health support for young people aged 16-25 with early symptoms, addressing the high threshold for seeking help and potentially reducing the risk of severe mental health issues.

This study will follow 125 participants over a year, using both qualitative and quantitative measures to assess psychological distress, functioning, and stress biomarkers, highlighting the importance of early intervention in mental health care, especially during the Covid-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. van Doorn, M., Popma, A., van Amelsvoort, T., et al.[2021]

A study involving 996 high-symptom adolescents tested two digital single-session interventions (SSIs) for depression, but found no significant difference in outcomes based on a treatment-matching algorithm, indicating that matching adolescents to specific SSIs may not enhance effectiveness.

The results suggest that predicting which adolescents will respond best to different SSIs is difficult, and that both interventions may be similarly effective, highlighting the potential public health benefit of increasing access to both types of SSIs rather than focusing on matching individuals to specific treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a treatment selection approach for online single-session interventions for adolescent depression. Ahuvia, IL., Mullarkey, MC., Sung, JY., et al.[2023]

Three computerized single-session interventions (SSIs) designed for Indian high schools were found to be acceptable and feasible according to focus group feedback from both students and educators, indicating a positive reception for mental health support.

The study aims to evaluate the effectiveness and implementation of these SSIs, suggesting that they could provide scalable and innovative solutions for youth mental health interventions in low- and middle-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Wasil, AR., Park, SJ., Gillespie, S., et al.[2021]

Despite the U.S. spending the most on mental health services, access remains low, especially for children and adolescents, with up to 80% not receiving necessary care.

Single-session interventions (SSIs) could improve accessibility and effectiveness of mental health services for youth, as evidence suggests they can help reduce and prevent various mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future Directions in Single-Session Youth Mental Health Interventions. Schleider, JL., Dobias, ML., Sung, JY., 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]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

This exploratory study involving interviews with 14 practitioners revealed that adverse effects of psychological therapies in children and adolescents are not well understood, highlighting the need for better detection and support mechanisms.

Practitioners identified key areas to focus on when managing adverse effects, including understanding the types and severity of effects, potential causes, and considering the perspectives of both the young clients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of psychological therapy: An exploratory study of practitioners' experiences from child and adolescent psychiatry. Jonsson, U., Johanson, J., Nilsson, E., et al.[2022]

A review of side effects (SEs) from psychotropic medications, including ADHD drugs, atypical antipsychotics, and antidepressants, revealed significant variability in SE incidence, which can affect student performance in school.

The study found that while all medications showed significant differences in SEs compared to placebo, many large risk ratio differences did not reach statistical significance, highlighting the need for careful monitoring and consideration of these medications by school psychologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant differences in pediatric psychotropic side effects: Implications for school performance. Kubiszyn, T., Mire, S., Dutt, S., et al.[2019]

Research shows that matching specific therapies to mental health diagnoses has little effect on treatment outcomes, indicating a need for new approaches in mental health care.

The Outcome Orientated Child and Adolescent Mental Health Services (OO-CAMHS) model, developed by a community mental health team, incorporates evidence-based practices that focus on feedback and patient alliance, showing promise in improving outcomes for young mental health service users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome Orientated Child and Adolescent Mental Health Services (OO-CAMHS): a whole service model. Timimi, S., Tetley, D., Burgoine, W., et al.[2019]

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