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

December 29, 2017 updated by: Fundación San Carlos de Maipo

Mental Health Prevention Among Preschool Children: a Pilot Study of the Adaptation of the I Can Problem Solve (ICPS) Program to Chile

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Santiago, Chile, 7510078
        • Fundacion San Carlos de Maipo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Educational institutions that meet the following inclusion criteria will be invited to participate:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.
Other Names:
  • Interpersonal Cognitive Problem Solving Program
Active Comparator: 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.
The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.
Other Names:
  • Interpersonal Cognitive Problem Solving Program
No Intervention: Control Group
School in the control group will continue to carry out their normal academic and prevention activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: 5 months
Acceptability of the intervention will be assessed using qualitative questionnaires
5 months
Feasibility
Time Frame: 5 months
Feasibility will be assessed by looking at the number of students successfully completing the study
5 months
Parental report of psychological difficulties
Time Frame: 8 months
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
Parental report of psychological strengths
Time Frame: 8 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Teacher report of psychological difficulties
Time Frame: 8 months
The psychological difficulties will be assessed using the total subscale of difficulties of the Teacher version of The Strengths and Difficulties Questionnaire (SDQ)
8 months
Teacher report of psychological strengths
Time Frame: 8 months
The psychological strengths will be assessed using the total subscale of difficulties of the Teacher version of The Strengths and Difficulties Questionnaire (SDQ)
8 months
Executive function
Time Frame: 8 months
Scores on the The Minnesota Executive Function Scale (MEFS)
8 months
Recognition of emotions
Time Frame: 8 months
Scores on the Assessment of Children's Emotions Scale (ACES)
8 months
Social problem solving skills
Time Frame: 8 months
Scores on the Challenging Situations Task (CST)
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jorge Gaete, MD, MSc, PhD, Universidad De Los Andes
  • Principal Investigator: Marcelo Sanchez, MSc, Fundacion San Carlos de Maipo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

December 30, 2018

Study Completion (Anticipated)

December 30, 2018

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSCM170505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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