Mental Health Prevention Among Preschool Children Using a Culturally Adapted Version of ICPS

NCT ID: NCT03383172

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-12-30

Brief Summary

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.

Detailed Description

Background. Mental health in Chilean children and families is an urgent public health problem. Several epidemiological studies have shown that a significant percentage of the adult population has psychiatric disorders. For example, one recent study showed that 31.5% of the population aged 15 and over has some type of psychiatric pathology in their lives, and that 22.2% suffered from a mental disorder during the last year (Vicente et al., 2006). Today we know that many of the disorders present in the adult population begin in childhood and adolescence and that preventing their onset can have a significant impact on the future functioning of the individual. The few epidemiological studies on the Chilean child and adolescent populations show that the 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% (Vicente et al., 2012). The most frequent disorders in the population between 4 and 11 years old were disruptive disorders (20.6%), followed by anxiety disorders (9.2%) (Vicente et al., 2012). Mental health problems generate a high burden of disease on society in general (Patel, et al., 2016); and there is an important gap in the treatment of these, especially in populations that are more economically vulnerable (Patel, et al., 2016). Prevention strategies appear to be the more recommendable options, mainly if these interventions can be implemented early and at low cost. Few preventive interventions, or interventions that increase resilience in the face of adversity, have been rigorously evaluated in Chile. There is substantial evidence that shows that strengthening social and emotional learning skills can reduce the incidence of mental pathology and improve various academic indicators (Domitrovich et al., 2017). These social-emotional skills include the ability to identify and express emotions, to be able to adapt to social context, to regulate emotions, the ability to inhibit behaviour, and problem-solving skills (Denham, 2006; Domitrovich et al., 2017). Deficits in these skills have been associated with the appearance of both internalization problems (emotional problems such as depression and anxiety) and externalization problems (such as disruptive behavioural problems), as well as peer rejection (Garner & Waajid, 2012).

The curriculum of the Interpersonal Cognitive Problem Solving Program, also known as I Can Problem Solve (ICPS) (Shure, 1992), is focused on the development of the cognitive process and children's social problem-solving skills. That is, it is a program that explicitly promotes cognitive regulation (skills for listening and paying attention, sequencing and planning tasks) and solving social problems (thinking up alternative solutions, causal thinking, means-to-an-end thinking, and sequential planning). But it also includes the promotion and learning of emotional processes (particularly emotional expression/knowledge, perspective, and empathy) (Jones et al., 2017). Several studies conducted among disadvantaged population have shown that students who received ICPS had better results regarding increasing pro-social behaviours and reducing aggressive behaviour compared with students in the control group (Shure & Spivack, 1982; Boyle & Hassett-Walker, 2008). ICPS is a universal intervention designed to promote interpersonal cognitive processes and problem-solving skills in children from preschool through 6th grade. This project will adapt the preschool program, which has a total of 59 sessions. Each session lasts around 20 minutes, and the trained facilitator follows a simple manual that guides their work with the students on ICPS vocabulary and concepts and the development of problem-solving skills such as practising alternative solutions, consequences and the sequential thought (solutions-consequences). An interactive technique and guided discussion strategies are used to solve problems. Interactive methods include games, role-playing, and the use of stories, illustrations and puppets. These contents may also be used in other curricular activities for children, whether they are working on Math, Reading or Science. Children learn how to think and not what to think.

Aims. The general 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 is of increasing social-emotional competence and reducing emotional and behavioural problems in preschoolers.

Methods. A pilot study consisting of two phases. Firstly, a formative stage when all intervention evaluation materials will be prepared, including the validation of instruments assessing socio-emotional skills; and curriculum of ICPS Preschool Program will be translated, edited and adapted, working closely with the author of the program Dr Myrna Shure. Secondly, the program will be implemented using a three-arm randomised controlled trial design. The acceptability and feasibility of its implementation in the national context will be evaluated, and changes in the development of social-emotional skills, behavioural problems and mental health, before and after the intervention. There will be two Intervention groups: 1) Schools implementing the ICPS program delivered by the school early teacher, trained by the research team; and 2) Schools implementing the ICPS program delivered by an early teacher hired and trained by the research team, who will work collaboratively with the school early teacher. A control group will consist of school implementing their usual teaching activities.

Conditions

Mental Health; Aggressive Childhood Behavior; Problem Behavior; Social Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ICPS with internal school facilitator

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.

Group Type: EXPERIMENTAL

I Can Problem Solve (ICPS) Program

Intervention Type: BEHAVIORAL

The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.

ICPS with external facilitator

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.

Group Type: ACTIVE_COMPARATOR

I Can Problem Solve (ICPS) Program

Intervention Type: BEHAVIORAL

The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.

Control Group

School in the control group will continue to carry out their normal academic and prevention activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

I Can Problem Solve (ICPS) Program

The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.

Intervention Type: BEHAVIORAL

Other Intervention Names

Interpersonal Cognitive Problem Solving Program

Eligibility Criteria

Inclusion Criteria

1. Municipal or subsidized educational institutions.

2. Mixed educational institutions.

3. Educational institutions with preschool education with at least one class per level.

4. Educational institutions with a high vulnerability index, given by IVESINAE ≥ 75%.

Exclusion Criteria

A criterion for exclusion will be educational institutions that are already developing or implementing a manualized program to promote social-emotional skills or participating in a similar study.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de los Andes, Chile

OTHER

Sponsor Role: collaborator

Fundación San Carlos de Maipo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge Gaete, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Los Andes

Marcelo Sanchez, MSc

Role: PRINCIPAL_INVESTIGATOR

Fundacion San Carlos de Maipo

Locations

Fundacion San Carlos de Maipo

Santiago, , Chile

Countries

Chile

References

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Reference Type: BACKGROUND

PMID: 16877648 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22646991 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26454360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25111741 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19491183 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28213889 (View on PubMed)

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.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Shure MB. I Can Problem Solve (ICPS). An interpersonal cognitive problem solving program (preschool). Champaign, IL: Research Press, 1992.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 7113996 (View on PubMed)

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

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 30832708 (View on PubMed)

Related Links

http://www.fsancarlos.cl

Home page of Fundación San Carlos de Maipo

http://www.uandes.cl

Home page of Universidad de los Andes

Other Identifiers

FSCM170505

Identifier Type: -

Identifier Source: org_study_id