Mental Health Prevention Among Preschool Children Effectiveness Study

NCT ID: NCT03683056

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-06-30

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 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.

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 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 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.

• 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

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Reference Type: BACKGROUND

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Reference Type: RESULT

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

FSCM180505

Identifier Type: -

Identifier Source: org_study_id