Clinical trial NCT03683056: Mental Health Prevention Among Preschool Children Effectiveness Study
Official title: Mental Health Prevention Among Preschool Children: The Effectiveness of I Can Problem Solve (ICPS) Program in Chile Using a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health
Aggressive Childhood Behavior
Problem Behavior
Social Behavior
Keywords: Prevention
Promotion
Mental Health
Lead sponsor: Fundación San Carlos de Maipo
Sponsor class: OTHER
Collaborators: name: Universidad de los Andes, Chile
First posted: 2018-09-25
Enrollment: 385
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 behaviors and reducing aggressive behavior 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 effectiveness of an adapted version of ICPS, in the national context at educational institutions with high socio-economic vulnerability, on increasing social-emotional competence and reducing emotional and behavioral 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. Today we know that many of the present in the adult population begins 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%. 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 gap in the treatment of these, especially in populations that are more economically vulnerable. 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. 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 behavior, and problem-solving skills. 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 behavioral problems), as well as peer rejection.

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. 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). Several studies conducted among disadvantaged population have shown that students who received ICPS had better results regarding increasing pro-social behaviors and reducing aggressive behavior compared with students in the control group. 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 practicing 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 effectiveness of an adapted version of ICPS, in the national context at educational institutions with a high socio-economic vulnerability, on increasing social-emotional competence and reducing emotional and behavioral problems in preschoolers.

Methods. A cluster randomized controlled study will be conducted to asses the effectiveness of the culturally adapted version of ICPS on increasing social-emotional skills and reducing behavioral problems. There will be two arms: 1) 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; 2) A control group will consist of school implementing their usual teaching activities.

Eligibility criteria: 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 two classes 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.

Primary outcomes:
measure: Recognition of emotions
timeFrame: 8 months
measure: Parental report of psychological difficulties
timeFrame: 8 months
Secondary outcomes:
measure: Social problem solving skills
timeFrame: 8 months
measure: Executive function
timeFrame: 8 months
measure: Parental report of psychological strengths
timeFrame: 8 months
measure: Teacher report of psychological difficulties
timeFrame: 8 months
measure: Teacher report of psychological strengths
timeFrame: 8 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Fundacion San Carlos de Maipo
Study officials:
affiliation: Universidad de Los Andes
name: Jorge Gaete, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion San Carlos de Maipo
name: Marcelo Sanchez, MSc
role: PRINCIPAL_INVESTIGATOR
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