Mental HealthICPS ChileNCT03683056
Mental Health Prevention Among Preschool Children Effectiveness Study
A study testing I Can Problem Solve (ICPS) Program in people with Mental Health and Aggressive Childhood Behavior, run by Fundación San Carlos de Maipo at 1 site in Chile.
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%. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Aggressive Childhood Behavior, Problem Behavior
- What is being tested?
- I Can Problem Solve (ICPS) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteChile
- Study dates
- 1 Sep 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Being tested
- I Can Problem Solve (ICPS) Program
- Keywords
- Prevention, Promotion, Mental Health
- Medical subject headings
- Psychological Well-Being, Problem Behavior, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I Can Problem Solve (ICPS) ProgramBehavioural
Also called Interpersonal Cognitive Problem Solving Program
The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.
| Study group | Role | What they receive |
|---|---|---|
| ICPS with external facilitator | Active comparator | 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. Receives: Behavioral: I Can Problem Solve (ICPS) Program |
| Control Group | No intervention | School in the control group will continue to carry out their normal academic and prevention activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Sep 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación San Carlos de Maipo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de los Andes, Chile
- Responsible party
- Sponsor
- Investigators
- Jorge Gaete, MD, MSc, PhD, Principal investigator, Universidad de los Andes, ChileMarcelo Sanchez, MSc, Principal investigator, Fundacion San Carlos de Maipo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683056
- Sponsor's protocol ID
- FSCM180505
- Acronym
- ICPS Chile
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1176/ajp.2006.163.8.1362.
PubMed 16877648Vicente 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.
PubMed 22646991Patel 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.
PubMed 26454360Bould 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.
PubMed 25111741Garber 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.
PubMed 19491183Domitrovich 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.
PubMed 28213889Denham 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.
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
Shure MB. I Can Problem Solve (ICPS). An interpersonal cognitive problem solving program (preschool). Champaign, IL: Research Press, 1992.
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.
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. doi: 10.1007/BF00896500.
PubMed 7113996Boyle 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03683056
- Acronym / sponsor ID
- ICPS Chile / FSCM180505
- Keywords
- Prevention, Promotion, Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Fundación San Carlos de MaipoUniversity, hospital or other
- Collaborators
- Universidad de los Andes, Chile
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICPS with external facilitator | Active comparator | Behavioral: I Can Problem Solve (ICPS) ProgramSchools 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. |
| Control Group | No intervention | –School in the control group will continue to carry out their normal academic and prevention activities. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I Can Problem Solve (ICPS) ProgramAlso: Interpersonal Cognitive Problem Solving ProgramThe 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills. | Behavioural | ICPS with external facilitator |
Primary outcome
Recognition of emotions
Time frame: 8 months
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.
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). 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.
5 secondary outcomes
Social problem solving skills
Time frame: 8 months
Executive function
Time frame: 8 months
Parental report of psychological strengths
Time frame: 8 months
Teacher report of psychological difficulties
Time frame: 8 months
Teacher report of psychological strengths
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Background: PubMed 16877648Vicente 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. doi: 10.1176/ajp.2006.163.8.1362.
- Background: PubMed 22646991Vicente 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.
- Background: PubMed 26454360Patel 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.
- Background: PubMed 25111741Bould 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.
- Background: PubMed 19491183Garber 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.
- Background: PubMed 28213889Domitrovich 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.
- BackgroundDenham 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.
- BackgroundGarner 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
- BackgroundShure MB. I Can Problem Solve (ICPS). An interpersonal cognitive problem solving program (preschool). Champaign, IL: Research Press, 1992.
- BackgroundJones 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.
- Results publication: PubMed 7113996Shure MB, Spivack G. Interpersonal problem-solving in young children: a cognitive approach to prevention. Am J Community Psychol. 1982 Jun;10(3):341-56. doi: 10.1007/BF00896500.
- Results publicationBoyle 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
- Home page of Fundación San Carlos de MaipoLink provided by the sponsor.
- Home page of Universidad de los AndesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Gaete, MD, MSc, PhD principal investigator
Universidad de los Andes, Chile
Marcelo Sanchez, MSc principal investigator
Fundacion San Carlos de Maipo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I Can Problem Solve (ICPS) Program in people with Mental Health and Aggressive Childhood Behavior, run by Fundación San Carlos de Maipo at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition of emotions (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683056, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.