Clinical trial NCT05453370: CALMA App as an Adjunct to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents
Official title: A Randomized 3-Month, Parallel-Group, Controlled Trial of CALMA M-Health App as an Adjunct to Therapy for the Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self-Injurious Behavior
Keywords: Self-Injurious Behavior
Mobile Applications
Dialectical Behavior Therapy
Suicide Prevention
Lead sponsor: University of Buenos Aires
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, two-arm randomized controlled trial design, which will employ an intervention condition (CALMA app) and a control condition (Treatment as usual -TAU) with a 3-month follow-up for each participant
Primary purpose: TREATMENT

Brief summary: Suicide in the second cause of death in subjects between 15 and 24 years of age. Despite the efficacy of interventions for the management of suicidal crises observed in some clinical trials, a crucial aspect for their effectiveness is accessibility. This leaves little time to intervene during the suicidal process. New platforms to provide evidence-based interventions, universally, economically, and quickly are needed. Smartphones appear to be a good alternative considering the high penetration of these devices locally.

The research group carried out a pilot randomized controlled cluster trial with four weeks of follow-up that provided initial evidence on the safety and acceptability of the app for reducing self-injurious thoughts and behaviors when used as an adjunct to conventional Dialectical Behavioral Therapy (DBT). This study conducted with a group of patients who were already undergoing DBT treatment program, and have shown good acceptability of CALMA as an adjunct to therapy targeting suicidal and non-suicidal self-injury behaviors. Although effectiveness was not the main outcome, results revealed a high probability to decrease suicidal outcomes including ideation, suicidal behaviors, Non-Suicidal Self-Injury (NSSI) and thoughts about NSSI in the group that received CALMA compared to the comparison group.

No specific app for adolescents and young people is available in Spanish. The research group developed CALMA (the Spanish word for "calm"), the first user-interactive mobile app in Spanish. It provides evidence-based tools to manage a suicidal or non-suicidal self-directed violence crisis. CALMA also interacts with the user between crises by promoting activities that reduce their vulnerability to suicide by provide psychoeducation about suicide and its prevention. Based on these encouraging initial findings, in this project the investigators propose to scale the intervention to a larger group of patients, focus it on adolescents and including public hospitals not specialized in DBT.

This is a parallel group, two-arm randomized controlled trial design, which will employ an intervention condition (CALMA app) and a control condition (Treatment as usual) with a 3-month follow-up for each participant, to evaluate the effectiveness, safety and acceptability of CALMA, a suicide prevention app for smartphones, to reduce the frequency of self-injurious thoughts and behaviors in adolescents who are assisted in a Mental Health service of three Public Hospitals.

Detailed description: Suicide and suicidal behaviors are among the leading causes of death and injury worldwide. Although in Argentina the overall suicide rate has remained relatively stable in the last 15 years, when analyzing the rates by age group, it is observed that in that same period there was a gradual and sustained growth in the suicide rate in subjects between 15 and 24 years of age. Despite the efficacy of interventions for the management of suicidal crises observed in some clinical trials, a crucial aspect for their effectiveness in daily practice is accessibility, that is, the availability of the intervention at the time of the crisis. This leaves little time to intervene during the suicidal process. This is why, beyond employing effective interventions to prevent suicide, it is necessary that they be quickly accessible at the time of crisis. New platforms to provide evidence-based interventions, universally, economically, and quickly are needed. Smartphones appear to be a good alternative considering the high penetration of these devices locally. The development of mobile applications (apps) for the prevention of suicidal behavior is recent.

The research group carried out a pilot randomized controlled cluster trial with four weeks of follow-up that provided initial evidence on the safety and acceptability of the app for reducing self-injurious thoughts and behaviors when used as an adjunct to conventional Dialectical Behavioral Therapy (DBT). This study conducted with a group of patients who were already undergoing DBT treatment program, have shown good acceptability of CALMA as an adjunct to therapy targeting suicidal and non-suicidal self-injury behaviors. Furthermore, although effectiveness was not the main outcome, results revealed a high probability to decrease suicidal outcomes including ideation, suicidal behaviors, Non-Suicidal Self-Injury (NSSI) and thoughts about NSSI in the group that received CALMA compared to the comparison group To investigators knowledge, no specific app for adolescents and young people is available in Spanish. The research group developed CALMA (the Spanish word for "calm"), the first user-interactive mobile app in Spanish. CALMA provides evidence-based tools to manage a suicidal or non-suicidal self-directed violence crisis with the goal of preventing death by suicide. CALMA also interacts with the user between crises by promoting activities that reduce their vulnerability to suicide by provide psychoeducation about suicide and its prevention. Based on these encouraging initial findings, in this project the investigators propose to scale the intervention to a larger group of patients, focus it on adolescents and include public hospitals not specialized in DBT.

The investigators are conducting a parallel group, two-arm randomized controlled trial design, which will employ an intervention condition (CALMA app) and a control condition (Treatment as usual -TAU) with a 3-month follow-up for each participant, to evaluate the effectiveness, safety and acceptability of CALMA, a suicide prevention app for smartphones, to reduce the frequency of self-injurious thoughts and behaviors in adolescents who are assisted in a Mental Health service of three Public Hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients from 10 to 19 years old who come on an outpatient basis or have been hospitalized in Mental Health Services
* Have a smartphone where the application can be installed and used are eligible to participate in the study
* Have attempted suicide, or exhibited a suicidal gesture or self-injurious behavior (according to the SITBI definition) in the last month before entering the study
* Agree to give their informed consent and their guardian agrees to sign your informed consent

Exclusion Criteria:

* If the participant plans not to continue the treatment in the next 3 months or
* Has an inability to provide assent/consent for cognitive or language reasons
* Do not have the functional capacity to use the application, which will be operationally determined by a score below 30 on the Self-Care motor domain, below 10 on the Communication cognitive domain or below 14 on the Cognitive domain of Social Knowledge in the Functional Independence Measurement scale (FIM).

Primary outcomes:
measure: Change in Frequency of Suicidal and Non-Suicidal Self-Injurious Behaviors.
timeFrame: Participants will be assessed at four timepoints: day-0 (baseline), day-30, day-60 and day-90.
Secondary outcomes:
measure: Levels of Emotional Dysregulation
timeFrame: Participants will be assessed at two timepoints: day-0 (baseline) and day-90.
measure: Levels of Engagement of the app.
timeFrame: Participants will be assessed at three timepoints: day-30, day-60, and day-90.
Other outcomes:
measure: Time (days) to psychiatric admission
timeFrame: from the date of enrollment to the date of the first psychiatric hospitalization for a self-injurious behavior up to 3 months. Participants will be assessed at the three follow-up timepoints: day-30, day-60, and day-90.
measure: Sociodemographic variables
timeFrame: Participants will be assessed at day-0 (baseline).
Locations:
city: City of Buenos Aires
country: Argentina
facility: Pedro de Elizalde Children's General Hospital
state: Buenos Aires
city: City of Buenos Aires
country: Argentina
facility: Institute of Pharmacology of the School of Medicine of the University of Buenos Aires
state: Buenos Aires
city: La Plata
country: Argentina
facility: Interzonal Acute Hospital "San Roque" de Gonnet
state: Buenos Aires
city: La Plata
country: Argentina
facility: Children's Hospital "Sor María Ludovica"
state: Buenos Aires
Study officials:
affiliation: Institute of Pharmacology, School of Medicine, University of Buenos Aires
name: Demián E Rodante, MD, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Pharmacology, School of Medicine, University of Buenos Aires
name: Federico M Daray, MD, MsC, PhD
role: STUDY_DIRECTOR
References:
citation: Daray FM, Olivera Fedi RH, Rodante DE. [Development of CALMA: A mobile APP for the prevention of suicide in adolescents and youth]. Vertex. 2018 Jan;29(137):55-64. Spanish.
citation: Rodante DE, Kaplan MI, Olivera Fedi R, Gagliesi P, Pascali A, Jose Quintero PS, Compte EJ, Perez AI, Weinstein M, Chiapella LC, Daray FM. CALMA, a Mobile Health Application, as an Accessory to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injured Behaviors: A Pilot Cluster Randomized Controlled Trial. Arch Suicide Res. 2022 Apr-Jun;26(2):801-818. doi: 10.1080/13811118.2020.1834476. Epub 2020 Oct 18.