Adaptive Intervention for Self-Harm
(ED_SMART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to develop a brief, family-based program to improve mental health care for young people who have self-harmed or considered suicide after leaving the emergency room. It employs a special design to tailor the adaptive intervention to each participant's needs, focusing on enhancing mental health understanding and communication within families. The trial tests various approaches, including digital support, text messages, and a family navigator who guides families through the mental health system. It is designed for youth aged 8 to 17 who have visited the ER for self-harm or suicidal thoughts and live at home with a caregiver. As an unphased trial, this study provides a unique opportunity for families to contribute to innovative mental health solutions tailored to their needs.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this adaptive intervention is safe for youth with self-injurious behavior?
Research has shown that digital tools can safely and effectively assist with self-harm and suicidal thoughts. These online methods reach young people who might not seek traditional help, focusing on prevention and support.
Text messages have been shown to reduce self-injury and improve mental health. These SMS interventions keep individuals engaged and provide ongoing support.
Combining text messages with a family navigator appears promising and is well-received. This approach involves families and offers more comprehensive support, which is crucial for young people.
Overall, these methods are generally well-tolerated, with few serious side effects. They provide a supportive and flexible way to address self-harm and improve access to mental health care.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for self-harm because they offer innovative, digital approaches that differ from traditional in-person therapy sessions. The treatments being tested are delivered digitally, making them more accessible and convenient for people who might struggle to attend regular therapy. One treatment option includes supportive text messages, while another adds a human family navigator to help guide the process, providing a more personalized touch. These features could make the interventions more engaging and supportive, potentially leading to better outcomes for individuals struggling with self-harm.
What evidence suggests that this trial's treatments could be effective for reducing self-harm?
Research has shown that digital programs can help reduce self-injury and suicidal behaviors. This trial will evaluate different digitally delivered psychosocial interventions. One arm of the trial will test a basic digital psychosocial program. Another arm will include text messages in addition to the digital program, as studies have found that adding text messages can lead to even greater reductions in self-harm and better mental health for young people. A third arm will incorporate both text messages and a family navigator, who helps families understand mental health care, potentially enhancing these benefits. Overall, digital programs, especially with added support like text messages and family guidance, have positively impacted reducing self-harm and improving mental health in youth.678910
Are You a Good Fit for This Trial?
This trial is for youth who have been admitted to the emergency department (ED) due to self-harm or suicidal thoughts. Participants should be in need of community-based mental health care post-admission. The study aims to help them engage with these services and reduce the risk of future ED visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Youth and caregivers receive 1st-stage interventions in the ED, either digitally delivered psychosocial or psychosocial with digital health communication via text messages
Adaptive Intervention
Non-responding dyads are re-randomized to 2nd-stage interventions, including the use of a family navigation model
Follow-up
Participants are monitored for engagement in community-based mental health care and reduction in SSIB risk
What Are the Treatments Tested in This Trial?
Interventions
- Adaptive Intervention
Trial Overview
The trial is testing a family-based adaptive intervention designed to improve mental health literacy, communication, and engagement among young people after an ED admission for self-harm or suicidal ideation. It uses a Sequential Multiple Assignment Randomized Trial (SMART) design.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Digitally delivered psychosocial with text messages and human family navigator
Digitally delivered psychosocial with text messages
Digitally delivered psychosocial
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rhode Island Hospital
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
Delivering real-time support for self-injury: A systematic review ...
Effective psychological and psychosocial approaches to reduce repetition of self-harm: a systematic review, meta-analysis and meta ...
Effectiveness of a Self-Guided Digital Intervention for ...
After completing the DWM intervention (T2), we observed significant improvements across all measured outcomes, with a reduction in psychological ...
Needs for mobile and internet-based psychological ...
In recent years, mobile psychological interventions have proven effective in reducing self-injury and suicide-related behaviors ... Psychosocial ...
a systematic review and meta-analysis - BMC Psychiatry
Effective psychological and psychosocial approaches to reduce repetition of self-harm: a systematic review, meta-analysis, and meta-regression.
Suicide prevention using self-guided digital interventions
Digital interventions that deliver psychological self-help provide the opportunity to reach individuals at risk of suicide who do not access traditional ...
Digital Interventions for Adolescents and Young Adults ...
... digital interventions for suicide prevention and NSSI. Focuses on intervention features, functions, purpose, and psychological strategies.
Delivering real-time support for self-injury: A systematic ...
There is substantial evidence supporting the efficacy of several psychological therapies preventing SITB, with Dialectical Behavioral Therapy (DBT) being a ...
8.
bmcpsychiatry.biomedcentral.com
bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-023-05477-2Needs for mobile and internet-based psychological ...
... psychological intervention should pay more attention to the protection of patients' life safety. ... Psychosocial interventions for self-harm in ...
Using a Digital Mental Health Intervention for Crisis Support ...
Psychosocial interventions for self-harm, suicidal ideation and suicide attempt in children and young people: What? How? Who? and Where ...
Suicide prevention using self-guided digital interventions
Digital interventions that deliver psychological self-help provide the opportunity to reach individuals at risk of suicide who do not access ...
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