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Sponsor study identifier
interventional
240
1 country
1
Study Start
August 1, 2017
Actual (reported)Primary Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mental health in Chilean children and families is an urgent public health problem. Prevalence of psychiatric disorders among children between 4 and 11 years old is 27.8%, a higher percentage than was found in adolescents between 12 and 18 years old, which is 16.5%. The most frequent disorders in the population between 4 and 11 years old were disruptive disorders (20.6%), followed by anxiety disorders (9.2%). Mental health problems generate a high burden of disease on society in general; and there is an important treatment gap, especially among economically vulnerable populations. Prevention strategies appear to be the more recommendable options, mainly if these interventions can be implemented early in life and at low cost. Few preventive interventions aiming to increase resilience in the face of adversity, have been rigorously evaluated in Chile among preschoolers. There is substantial international evidence that shows that strengthening basic psychological skills, such as emotion regulation and social problem-solving, can reduce the incidence of mental pathology and improve various academic indicators. The curriculum of the Interpersonal Cognitive Problem Solving Program, also known as I Can Problem Solve (ICPS), is focused on the development of the cognitive process and children's social problem-solving skills. ICPS has been found to be effective in increasing pro-social behaviours and reducing aggressive behaviour among preschoolers. No previous studies in Spanish-speaking Latin American countries have been conducted aiming to explore the acceptability and feasibility of ICPS to provide information to evaluate later the effectiveness of this intervention at a larger scale. The main objective of this study is the evaluation of the acceptability and feasibility of an adapted version of ICPS in the national context at educational institutions with high socio-economic vulnerability, with the ultimate goal of increasing social-emotional competence and reducing emotional and behavioural problems in preschoolers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2017
Actual (reported)December 19, 2017
Actual (reported)December 26, 2017
Actual (reported)December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Acceptability
Acceptability of the intervention will be assessed using qualitative questionnaires
5 months
Feasibility
Feasibility will be assessed by looking at the number of students successfully completing the study
5 months
Parental report of psychological difficulties
The psychological difficulties will be assessed using the total subscale of difficulties of the Parents version of The Strengths and Difficulties Questionnaire (SDQ)
8 months
Schools with preschool students. All consented students in the class will participate in the ICPS preschool program, adapted to the Chilean reality and culture. The program is manualized and will be delivered by the early educator of the class, who is part of the school personnel.This internal facilitator will be trained in the program. Each of the 59 sessions lasts around 20 minutes, delivered 2 to 3 times a week, during 5 months. ICPS content includes vocabulary and concepts about emotions, and the development of problem-solving skills, practising alternative solutions, consequences and the sequential thought (solutions-consequences). Interactive techniques (e.g. games, role-playing, and the use of stories, illustrations and puppets), and guided discussion strategies are used to solve problems.
Schools with preschool students. All consented students in the class will participate in the ICPS preschool program, adapted to the Chilean reality and culture. The program is manualized and will be delivered by an external trained early educator, who is part of the research team. The early educator of the class, who is part of the school personnel, will also be trained to collaborate with all the program activities with the external facilitator. Each of the 59 sessions lasts around 20 minutes, delivered 2 to 3 times a week, during 5 months. ICPS content includes vocabulary and concepts about emotions, and the development of problem-solving skills, practising alternative solutions, consequences and the sequential thought (solutions-consequences). Interactive techniques (e.g. games, role-playing, and the use of stories, illustrations and puppets), and guided discussion strategies are used to solve problems.
The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fundacion San Carlos de Maipo
Santiago, 7510078, Chile
Vicente B, Kohn R, Rioseco P, Saldivia S, Levav I, Torres S. Lifetime and 12-month prevalence of DSM-III-R disorders in the Chile psychiatric prevalence study. Am J Psychiatry. 2006 Aug;163(8):1362-70. doi: 10.1176/ajp.2006.163.8.1362.
Vicente B, Saldivia S, de la Barra F, Kohn R, Pihan R, Valdivia M, Rioseco P, Melipillan R. Prevalence of child and adolescent mental disorders in Chile: a community epidemiological study. J Child Psychol Psychiatry. 2012 Oct;53(10):1026-35. doi: 10.1111/j.1469-7610.2012.02566.x. Epub 2012 May 31.
Jorge Gaete, MD, MSc, PhD
Universidad de los Andes, Chile
Marcelo Sanchez, MSc
Fundacion San Carlos de Maipo
First Submitted
December 19, 2017
First Posted
December 26, 2017
Study Start
August 1, 2017
Actual (reported)Primary Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Parental report of psychological strengths
The psychological strengths will be assessed using the total subscale of difficulties of the Parents version of The Strengths and Difficulties Questionnaire (SDQ)
8 months
Teacher report of psychological difficulties
8 months
Teacher report of psychological strengths
8 months
Executive function
8 months
Recognition of emotions
8 months
Social problem solving skills
8 months
School in the control group will continue to carry out their normal academic and prevention activities.
Contact the study team to confirm eligibility.
Patel V, Chisholm D, Parikh R, Charlson FJ, Degenhardt L, Dua T, Ferrari AJ, Hyman S, Laxminarayan R, Levin C, Lund C, Medina Mora ME, Petersen I, Scott J, Shidhaye R, Vijayakumar L, Thornicroft G, Whiteford H; DCP MNS Author Group. Addressing the burden of mental, neurological, and substance use disorders: key messages from Disease Control Priorities, 3rd edition. Lancet. 2016 Apr 16;387(10028):1672-85. doi: 10.1016/S0140-6736(15)00390-6. Epub 2015 Oct 8.
Bould H, Araya R, Pearson RM, Stapinski L, Carnegie R, Joinson C. Association between early temperament and depression at 18 years. Depress Anxiety. 2014 Sep;31(9):729-36. doi: 10.1002/da.22294. Epub 2014 Aug 8.
Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S. Prevention of depression in at-risk adolescents: a randomized controlled trial. JAMA. 2009 Jun 3;301(21):2215-24. doi: 10.1001/jama.2009.788.
Domitrovich CE, Durlak JA, Staley KC, Weissberg RP. Social-Emotional Competence: An Essential Factor for Promoting Positive Adjustment and Reducing Risk in School Children. Child Dev. 2017 Mar;88(2):408-416. doi: 10.1111/cdev.12739. Epub 2017 Feb 18.
Denham SA. Social-Emotional Competence as Support for School Readiness: What Is It and How Do We Assess It? Early Education and Development, 17(1), 57-89, 2006.
Garner PW, Waajid B. Emotion Knowledge and Self-Regulation as Predictors of Preschoolers' Cognitive Ability, Classroom Behavior, and Social Competence. Journal of Psychoeducational Assessment, 30(4), 330-343, 2012. doi:10.1177/0734282912449441
Shure MB. I Can Problem Solve (ICPS). An interpersonal cognitive problem solving program (preschool). Champaign, IL: Research Press, 1992.
Jones S, Brush K, Bailey R, Brion-Meisels G, McIntyre J, HKahn J, et al. Navigating SEL from the Inside Out. Looking inside and across 25 leading SEL programs: A practical resource for schools and OST providers. 2017.
Shure MB, Spivack G. Interpersonal problem-solving in young children: a cognitive approach to prevention. Am J Community Psychol. 1982 Jun;10(3):341-56. doi: 10.1007/BF00896500.
Boyle D, Hassett-Walker C. Reducing Overt and Relational Aggression Among Young Children. Journal of School Violence, 7(1), 27-42, 2008. doi:10.1300/J202v07n01_03
Gaete J, Sanchez M, Nejaz L, Otegui M. Mental Health Prevention in Preschool Children: study protocol for a feasibility and acceptability randomised controlled trial of a culturally adapted version of the I Can Problem Solve (ICPS) Programme in Chile. Trials. 2019 Mar 4;20(1):158. doi: 10.1186/s13063-019-3245-3.
Study Completion
December 30, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 3, 2018
Record last verified: 2017-12
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Source: ClinicalTrials.gov.
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