A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol
BackgroundSuicidal and non-suicidal self-injurious behaviors are among the leading causes of death and injury in adolescents and youth worldwide. Mobile app development could help people at risk and provide resources to deliver evidence-based interventions. There is no specific application for adole...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-07-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1087097/full |
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| author | Demián Emanuel Rodante Demián Emanuel Rodante Demián Emanuel Rodante Luciana Carla Chiapella Luciana Carla Chiapella Ramiro Olivera Fedi Eliana Belén Papávero Eliana Belén Papávero Eliana Belén Papávero Kim L. Lavoie Kim L. Lavoie Federico Manuel Daray Federico Manuel Daray |
| author_facet | Demián Emanuel Rodante Demián Emanuel Rodante Demián Emanuel Rodante Luciana Carla Chiapella Luciana Carla Chiapella Ramiro Olivera Fedi Eliana Belén Papávero Eliana Belén Papávero Eliana Belén Papávero Kim L. Lavoie Kim L. Lavoie Federico Manuel Daray Federico Manuel Daray |
| author_sort | Demián Emanuel Rodante |
| collection | DOAJ |
| description | BackgroundSuicidal and non-suicidal self-injurious behaviors are among the leading causes of death and injury in adolescents and youth worldwide. Mobile app development could help people at risk and provide resources to deliver evidence-based interventions. There is no specific application for adolescents and young people available in Spanish. Our group developed CALMA, the first interactive mobile application with the user in Spanish, which provides tools based on Dialectical Behavioral Therapy to manage a crisis of suicidal or non-suicidal self-directed violence with the aim of preventing suicide in adolescents and youth.MethodsTo test the effectiveness, safety and level of engagement of the CALMA app in people aged 10 to 19 who are treated in mental health services of two public hospitals, we will conduct a parallel-group, two-arm randomized controlled trial. Participants will be assessed face-to-face and via video call at four timepoints: day-0 (baseline), day-30, day-60, and day-90. A total of 29 participants per group will be included. Change in the frequency of suicidal and non-suicidal self-injurious behaviors will be compared between groups, as well as the level of emotional dysregulation, level of app engagement and time of psychiatric admission during the follow-up period.DiscussionThis study is particularly relevant to young people given their widespread use of mobile technology, while there are currently no available smartphone app-based self-guided psychological strategies in Spanish that attempt to reduce suicidal behavior in adolescents who are assisted in the public health sector from low and middle-income countries in Latin America.Clinical trial registrationhttps://clinicaltrials.gov/, NCT05453370. |
| first_indexed | 2024-03-12T22:50:16Z |
| format | Article |
| id | doaj.art-9529e7b0c7b24da4bbd6195a244e9ef9 |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-03-12T22:50:16Z |
| publishDate | 2023-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj.art-9529e7b0c7b24da4bbd6195a244e9ef92023-07-20T14:08:13ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402023-07-011410.3389/fpsyt.2023.10870971087097A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocolDemián Emanuel Rodante0Demián Emanuel Rodante1Demián Emanuel Rodante2Luciana Carla Chiapella3Luciana Carla Chiapella4Ramiro Olivera Fedi5Eliana Belén Papávero6Eliana Belén Papávero7Eliana Belén Papávero8Kim L. Lavoie9Kim L. Lavoie10Federico Manuel Daray11Federico Manuel Daray12Facultad de Medicina, Universidad de Buenos Aires, Instituto de Farmacología, Buenos Aires, Argentina“Dr. Braulio A. Moyano” Neuropsychiatric Hospital, Buenos Aires, ArgentinaFORO Foundation for Mental Health, Buenos Aires, ArgentinaPharmacology Area, Faculty of Biochemical and Pharmaceutical Sciences, National University of Rosario, Rosario, ArgentinaConsejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, ArgentinaFacultad de Medicina, Universidad de Buenos Aires, Instituto de Farmacología, Buenos Aires, ArgentinaFacultad de Medicina, Universidad de Buenos Aires, Instituto de Farmacología, Buenos Aires, ArgentinaFORO Foundation for Mental Health, Buenos Aires, ArgentinaPedro de Elizalde Children’s General Hospital, Buenos Aires, ArgentinaMontreal Behavioural Medicine Centre, Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l’Île-de-Montréal, Montreal, QC, CanadaDepartment of Psychology, Université du Québec à Montréal, Montreal, QC, CanadaFacultad de Medicina, Universidad de Buenos Aires, Instituto de Farmacología, Buenos Aires, ArgentinaConsejo Nacional de Investigaciones Científicas y Técnicas, Buenos Aires, ArgentinaBackgroundSuicidal and non-suicidal self-injurious behaviors are among the leading causes of death and injury in adolescents and youth worldwide. Mobile app development could help people at risk and provide resources to deliver evidence-based interventions. There is no specific application for adolescents and young people available in Spanish. Our group developed CALMA, the first interactive mobile application with the user in Spanish, which provides tools based on Dialectical Behavioral Therapy to manage a crisis of suicidal or non-suicidal self-directed violence with the aim of preventing suicide in adolescents and youth.MethodsTo test the effectiveness, safety and level of engagement of the CALMA app in people aged 10 to 19 who are treated in mental health services of two public hospitals, we will conduct a parallel-group, two-arm randomized controlled trial. Participants will be assessed face-to-face and via video call at four timepoints: day-0 (baseline), day-30, day-60, and day-90. A total of 29 participants per group will be included. Change in the frequency of suicidal and non-suicidal self-injurious behaviors will be compared between groups, as well as the level of emotional dysregulation, level of app engagement and time of psychiatric admission during the follow-up period.DiscussionThis study is particularly relevant to young people given their widespread use of mobile technology, while there are currently no available smartphone app-based self-guided psychological strategies in Spanish that attempt to reduce suicidal behavior in adolescents who are assisted in the public health sector from low and middle-income countries in Latin America.Clinical trial registrationhttps://clinicaltrials.gov/, NCT05453370.https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1087097/fulldialectical behavioral therapymobile health applicationsuicide preventionsuicide and self-harmchild and adolescent psychiatry |
| spellingShingle | Demián Emanuel Rodante Demián Emanuel Rodante Demián Emanuel Rodante Luciana Carla Chiapella Luciana Carla Chiapella Ramiro Olivera Fedi Eliana Belén Papávero Eliana Belén Papávero Eliana Belén Papávero Kim L. Lavoie Kim L. Lavoie Federico Manuel Daray Federico Manuel Daray A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol Frontiers in Psychiatry dialectical behavioral therapy mobile health application suicide prevention suicide and self-harm child and adolescent psychiatry |
| title | A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol |
| title_full | A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol |
| title_fullStr | A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol |
| title_full_unstemmed | A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol |
| title_short | A randomized 3-month, parallel-group, controlled trial of CALMA m-health app as an adjunct to therapy to reduce suicidal and non-suicidal self-injurious behaviors in adolescents: study protocol |
| title_sort | randomized 3 month parallel group controlled trial of calma m health app as an adjunct to therapy to reduce suicidal and non suicidal self injurious behaviors in adolescents study protocol |
| topic | dialectical behavioral therapy mobile health application suicide prevention suicide and self-harm child and adolescent psychiatry |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1087097/full |
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