Mental Health Prevention Among Preschool Children Effectiveness Study

Mental Health Clinical Trial

— ICPS Chile  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03683056
• Other study ID #: FSCM180505
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2018
• Source: Fundación San Carlos de Maipo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 385
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Aggressive Childhood Behavior
• Mental Health
• Problem Behavior
• Social Behavior

Intervention

Behavioral:
• I Can Problem Solve (ICPS) Program
The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.

Locations

Country	Name	City	State
Chile	Fundacion San Carlos de Maipo	Santiago

Sponsors (2)

Lead Sponsor	Collaborator
Fundación San Carlos de Maipo	Universidad Los Andes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (12)

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. — View Citation

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

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.

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. Review. — View Citation

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. — View Citation

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

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.

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. Review. Erratum in: Lancet. 2016 Apr 16;387(10028):1618. — View Citation

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. — View Citation

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

Vicente B, Kohn R, Rioseco P, Saldivia S, Levav I, Torres S. Lifetime and 12-month prevalence of DSM-III-R disorders in the Chile psychiatric prevalence study. Am J Psychiatry. 2006 Aug;163(8):1362-70. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Home page of Fundación San Carlos de Maipo
•   Home page of Universidad de los Andes