Mental HealthNCT03383172
Mental Health Prevention Among Preschool Children Using a Culturally Adapted Version of ICPS
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
- 240 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2017to 30 Dec 2018
- 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 one class 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: a Pilot Study of the Adaptation of the I Can Problem Solve (ICPS) Program to Chile
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 behaviours and reducing aggressive behaviour 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 acceptability and feasibility of an adapted version of ICPS in the national context at educational institutions with high socio-economic vulnerability, with the ultimate goal of increasing social-emotional competence and reducing emotional and behavioural 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 (Vicente et al., 2006). Today we know that many of the disorders present in the adult population begin 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% (Vicente et al., 2012). The most frequent disorders in the population between 4 and 11 years old were disruptive disorders (20.6%), followed by anxiety disorders (9.2%) (Vicente et al., 2012). Mental health problems generate a high burden of disease on society in general (Patel, et al., 2016); and there is an important gap in the treatment of these, especially in populations that are more economically vulnerable (Patel, et al., 2016). 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 (Domitrovich et al., 2017). 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 behaviour, and problem-solving skills (Denham, 2006; Domitrovich et al., 2017). 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 behavioural problems), as well as peer rejection (Garner \& Waajid, 2012).
The curriculum of the Interpersonal Cognitive Problem Solving Program, also known as I Can Problem Solve (ICPS) (Shure, 1992), 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) (Jones et al., 2017). Several studies conducted among disadvantaged population have shown that students who received ICPS had better results regarding increasing pro-social behaviours and reducing aggressive behaviour compared with students in the control group (Shure \& Spivack, 1982; Boyle \& Hassett-Walker, 2008). 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 practising 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 acceptability and feasibility of an adapted version of ICPS in the national context at educational institutions with high socio-economic vulnerability, with the ultimate goal is of increasing social-emotional competence and reducing emotional and behavioural problems in preschoolers.
Methods. A pilot study consisting of two phases. Firstly, a formative stage when all intervention evaluation materials will be prepared, including the validation of instruments assessing socio-emotional skills; and curriculum of ICPS Preschool Program will be translated, edited and adapted, working closely with the author of the program Dr Myrna Shure. Secondly, the program will be implemented using a three-arm randomised controlled trial design. The acceptability and feasibility of its implementation in the national context will be evaluated, and changes in the development of social-emotional skills, behavioural problems and mental health, before and after the intervention. There will be two Intervention groups: 1) Schools implementing the ICPS program delivered by the school early teacher, trained by the research team; and 2) 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. 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 internal school facilitator | Experimental | 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 the early educator of the class, who is part of the school personnel.This internal facilitator will be trained in the program. 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 |
| 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.
Acceptability
Acceptability of the intervention will be assessed using qualitative questionnaires
Measured: 5 months
Feasibility
Feasibility will be assessed by looking at the number of students successfully completing the study
Measured: 5 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)
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)
Measured: 8 months
Secondary outcomes (5)
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)
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)
Measured: 8 months
Executive function
Scores on the The Minnesota Executive Function Scale (MEFS)
Measured: 8 months
Recognition of emotions
Scores on the Assessment of Children's Emotions Scale (ACES)
Measured: 8 months
Social problem solving skills
Scores on the Challenging Situations Task (CST)
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 posted26 Dec 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 240 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
- NCT03383172
- Sponsor's protocol ID
- FSCM170505
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 3 Jan 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
Gaete J, Sanchez M, Nejaz L, Otegui M. Mental Health Prevention in Preschool Children: study protocol for a feasibility and acceptability randomised controlled trial of a culturally adapted version of the I Can Problem Solve (ICPS) Programme in Chile. Trials. 2019 Mar 4;20(1):158. doi: 10.1186/s13063-019-3245-3.
PubMed 30832708
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Prevention Among Preschool Children: a Pilot Study of the Adaptation of the I Can Problem Solve (ICPS) Program to Chile
- ClinicalTrials.gov ID
- NCT03383172
- Acronym / sponsor ID
- FSCM170505
- Keywords
- Prevention, Promotion, Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fundación San Carlos de MaipoUniversity, hospital or other
- Collaborators
- Universidad de los Andes, Chile
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 26 Dec 2017 (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 behaviours and reducing aggressive behaviour 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 acceptability and feasibility of an adapted version of ICPS in the national context at educational institutions with high socio-economic vulnerability, with the ultimate goal of increasing social-emotional competence and reducing emotional and behavioural 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 (Vicente et al., 2006). Today we know that many of the disorders present in the adult population begin 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% (Vicente et al., 2012). The most frequent disorders in the population between 4 and 11 years old were disruptive disorders (20.6%), followed by anxiety disorders (9.2%) (Vicente et al., 2012). Mental health problems generate a high burden of disease on society in general (Patel, et al., 2016); and there is an important gap in the treatment of these, especially in populations that are more economically vulnerable (Patel, et al., 2016). 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 (Domitrovich et al., 2017). 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 behaviour, and problem-solving skills (Denham, 2006; Domitrovich et al., 2017). 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 behavioural problems), as well as peer rejection (Garner \& Waajid, 2012).
The curriculum of the Interpersonal Cognitive Problem Solving Program, also known as I Can Problem Solve (ICPS) (Shure, 1992), 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) (Jones et al., 2017). Several studies conducted among disadvantaged population have shown that students who received ICPS had better results regarding increasing pro-social behaviours and reducing aggressive behaviour compared with students in the control group (Shure \& Spivack, 1982; Boyle \& Hassett-Walker, 2008). 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 practising 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 acceptability and feasibility of an adapted version of ICPS in the national context at educational institutions with high socio-economic vulnerability, with the ultimate goal is of increasing social-emotional competence and reducing emotional and behavioural problems in preschoolers.
Methods. A pilot study consisting of two phases. Firstly, a formative stage when all intervention evaluation materials will be prepared, including the validation of instruments assessing socio-emotional skills; and curriculum of ICPS Preschool Program will be translated, edited and adapted, working closely with the author of the program Dr Myrna Shure. Secondly, the program will be implemented using a three-arm randomised controlled trial design. The acceptability and feasibility of its implementation in the national context will be evaluated, and changes in the development of social-emotional skills, behavioural problems and mental health, before and after the intervention. There will be two Intervention groups: 1) Schools implementing the ICPS program delivered by the school early teacher, trained by the research team; and 2) 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. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| ICPS with internal school facilitator | Experimental | 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 the early educator of the class, who is part of the school personnel.This internal facilitator will be trained in the program. 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. |
| 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 one class 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, ICPS with internal school facilitator |
Primary outcome
Acceptability
Time frame: 5 months
Acceptability of the intervention will be assessed using qualitative questionnaires
Feasibility
Time frame: 5 months
Feasibility will be assessed by looking at the number of students successfully completing the study
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)
Parental report of psychological strengths
Time frame: 8 months
The psychological strengths will be assessed using the total subscale of difficulties of the Parents version of The Strengths and Difficulties Questionnaire (SDQ)
5 secondary outcomes
Teacher report of psychological difficulties
Time frame: 8 months
Teacher report of psychological strengths
Time frame: 8 months
Executive function
Time frame: 8 months
Recognition of emotions
Time frame: 8 months
Social problem solving skills
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 3 Jan 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 3 Jan 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?
Acceptability (time frame: 5 months). The study lists 4 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 NCT03383172, which also lists 13 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 3 Jan 2018.