Mental Health Prevention Among Preschool Children Effectiveness Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mental Health Prevention Among Preschool Children: The Effectiveness of I Can Problem Solve (ICPS) Program in Chile Using a Cluster Randomized Controlled Trial

Conditions
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Mental Health, Aggressive Childhood Behavior, Problem Behavior, Social Behavior

Intervention / Treatment
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* Behavioral: I Can Problem Solve (ICPS) Program


Participation Criteria
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Eligibility Criteria
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Educational institutions that meet the following inclusion criteria will be invited to participate: Inclusion Criteria: Municipal or subsidized educational institutions. Mixed educational institutions. Educational institutions with preschool education with at least two classes per level. 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICPS with external facilitator<br>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. | Behavioral: I Can Problem Solve (ICPS) Program<br>* The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.<br>* Other names: Interpersonal Cognitive Problem Solving Program;|
| No Intervention: Control Group<br>School in the control group will continue to carry out their normal academic and prevention activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recognition of emotions | Scores on the Assessment of Children's Emotions Scale (ACES). The ACES evaluates emotion expression knowledge. The 26-item sub-scale consists of colour photographs of ethnically diverse elementary schoolchildren depicting four expressions of each of the four basic emotions (happy, sad, angry, and scared) and 10 images of children without obvious facial expressions. The examiner shows the child the photographs one at a time and each time asks, Is the child in the picture happy, sad, angry, or scared? Then the examiner registers the child's answer. The emotion accuracy score reflects how many items the children answer correctly. The total score ranges from 0 to 16. Higher scores mean better emotion recognition. | 8 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). This 25-question questionnaire explores different symptoms grouped into 5 sub-scales (with 5 items each): (1) emotional symptoms, (2) behavioural problems, (3) problems with peers, (4) symptoms of lack of attention and hyperactivity, and (5) prosocial skills. The first four sub-scales refer to difficulties that children may have and may be grouped together in a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviours in relationships with others. Each item is answered on a scale of responses from 0=not true to 2=absolutely true. This scale has shown good psychometric characteristics. The score of sub-scale of difficulties ranges from 0 to 40, and the abnormal range is 17-40 points. Higher scores mean higher emotional and behavioral symptoms. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social problem solving skills | Scores on the Challenging Situations Task (CST). This instrument evaluates the ability of children to solve social problems. The children are presented with six vignettes that describe problems between peers. Following the presentation of each challenging situation, four pictures of behavioral responses (prosocial, aggressive, manipulation of others' feelings, and avoidant) are presented in random order and the child is asked What do you do [in this situation]? The answers are categorised into four possibilities: (1) prosocial, (2) aggressive, (3) cry, and (4) avoidant. Scores for behavioral responses used are the number of times each behavioral response is chosen by each child across the six situations. The higher frequency of aggressive, cry or avoidant responses means lower social problem-solving skills. | 8 months | 
| Executive function | Scores on the The Minnesota Executive Function Scale (MEFS). This instrument is used to evaluate the executive functions, specifically, cognitive flexibility, working memory, and inhibitory control, among individuals beginning at age 24 months and extending throughout the lifespan. It is an adaptive virtual card-sorting task delivered on a tablet (2-6 minutes; 4-minute average test duration). The MEFS has been used with more than 17,000 individuals and has been found to be reliable and valid. It is normed on a representative sample of 7,410 typically developing children ages 2-13 years and 553 adults. This measure also has been validated in at-risk preschoolers. It is related to emotional understanding in preschoolers. The MEFS is sensitive to training intervention, especially in low-income children. Higher scores mean better executive function performance. | 8 months | 
| 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). This 25-question questionnaire explores different symptoms grouped into 5 sub-scales (with 5 items each): (1) emotional symptoms, (2) behavioural problems, (3) problems with peers, (4) symptoms of lack of attention and hyperactivity, and (5) prosocial skills. The first four sub-scales refer to difficulties that children may have and may be grouped together in a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviours in relationships with others. Each item is answered on a scale of responses from 0=not true to 2=absolutely true. This scale has shown good psychometric characteristics. The score of sub-scale of strengths ranges from 0 to 10, and the abnormal range is 0-4 points. Higher scores mean higher social strengths. | 8 months | 
| Teacher report of psychological difficulties | The psychological difficulties will be assessed using the total subscale of difficulties of the Teacher version of The Strengths and Difficulties Questionnaire (SDQ). This 25-question questionnaire explores different symptoms grouped into 5 sub-scales (with 5 items each): (1) emotional symptoms, (2) behavioural problems, (3) problems with peers, (4) symptoms of lack of attention and hyperactivity, and (5) prosocial skills. The first four sub-scales refer to difficulties that children may have and may be grouped together in a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviours in relationships with others. Each item is answered on a scale of responses from 0=not true to 2=absolutely true. This scale has shown good psychometric characteristics. The score of sub-scale of strengths ranges from 0 to 10, and the abnormal range is 0-4 points. Higher scores mean higher social strengths. | 8 months | 
| Teacher report of psychological strengths | The psychological strengths will be assessed using the total subscale of difficulties of the Teacher version of The Strengths and Difficulties Questionnaire (SDQ). This 25-question questionnaire explores different symptoms grouped into 5 sub-scales (with 5 items each): (1) emotional symptoms, (2) behavioural problems, (3) problems with peers, (4) symptoms of lack of attention and hyperactivity, and (5) prosocial skills. The first four sub-scales refer to difficulties that children may have and may be grouped together in a general sub-scale of difficulties (20 items). The sub-scale of prosocial skills refers to positive and adaptive behaviours in relationships with others. Each item is answered on a scale of responses from 0=not true to 2=absolutely true. This scale has shown good psychometric characteristics. The score of sub-scale of difficulties ranges from 0 to 40, and the abnormal range is 16-40 points. Higher scores mean higher emotional and behavioral symptoms. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Promotion, Mental Health