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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.

ABSTRACT: BACKGROUND:Difficulties with delaying gratification, coping with frustration, and regulating emotions are significant predictors of aggression and behavioural and interpersonal problems early in life and mental health disorders during childhood, adolescence, and adulthood. Mental health problems generate a high burden of disease in society in general, and there is a significant 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 among Chilean preschoolers. Substantial international evidence indicates 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 Programme, also known as I Can Problem Solve (ICPS), is focussed on the development of the cognitive process and children's social problem-solving skills. ICPS is effective at increasing prosocial behaviours and reducing aggressive behaviour among preschoolers. ICPS provides children with the skills to think about how to solve problems using sequenced games, discussion, and group-interaction techniques focussed on listening to, and observing, others, promoting empathy and alternative and consequential thinking. The aims of this study are (1) to develop a culturally appropriate version of the ICPS programme and (2) to evaluate the acceptability and feasibility of the adapted version of ICPS among vulnerable schools in Santiago, Chile, conducting a pilot randomised controlled trial with three arms: (1) the ICPS programme delivered by an internal early teacher, (2) the ICPS programme delivered by an external early teacher, and (3) a control group. METHODS AND DESIGN:This is a pilot, three-armed randomised controlled trial of the adapted version of ICPS with an enrolment target of 80 preschoolers attending four schools per arm. Children in both intervention groups will receive the ICPS programme: 59 sessions of 20?min each delivered three times a week by trained internal or external early teachers over 5-6?months. Internal teachers are part of the school staff, and external teachers are facilitators hired by the research team to go to schools and deliver the intervention during a normal school day, working together with the early teacher present in the classroom. The intervention consists of games using pictures, puppets, and simple role-playing techniques to facilitate the learning process. Cognitive regulation, emotion recognition, social-problem-solving skills, and psychological functioning will be measured at baseline and after the intervention. DISCUSSION:No previous studies in Spanish-speaking Latin American countries have been conducted to explore the acceptability and feasibility of ICPS to provide information to evaluate the effectiveness of this intervention on a larger scale. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03383172 . Registered on 26 December 2017.

SUBMITTER: Gaete J

PROVIDER: S-EPMC6399921 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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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.

Gaete Jorge J Sánchez Marcelo M Nejaz Lorena L Otegui Mikele M

Trials 20190304 1

<h4>Background</h4>Difficulties with delaying gratification, coping with frustration, and regulating emotions are significant predictors of aggression and behavioural and interpersonal problems early in life and mental health disorders during childhood, adolescence, and adulthood. Mental health problems generate a high burden of disease in society in general, and there is a significant treatment gap, especially among economically vulnerable populations. Prevention strategies appear to be the mor ...[more]

PMID: 30832708

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Project description:BackgroundPostpartum depression and anxiety are the 2 most common perinatal mental health disorders, with prevalence rates higher among women living in the Middle East than in most Western countries. The negative outcomes associated with postpartum depression and anxiety are profound and include less responsive parenting and compromised infant and young child development. Although interventions exist to prevent postpartum depression and anxiety, to date, there have been no studies that have attempted to prevent postpartum depression or anxiety among Arabic-speaking women in the Middle East, including Qatar.ObjectiveThe purpose of this study is to conduct a randomized controlled trial (RCT) of an evidence-based postpartum depression preventive intervention-Mothers and Babies (MB)-culturally adapted for use with Arabic-speaking women in Doha, Qatar. MB is guided by a cognitive behavioral therapy framework that focuses on increasing pleasant activities, promoting healthy thought patterns, and increasing the type and frequency of personal contacts. MB is tailored to specific needs and issues related to pregnancy and the postpartum period.MethodsA multidisciplinary and multiethnic investigator team adapted MB to promote cultural and contextual fit for Arabic-speaking women. Intervention concepts were reviewed to ensure core content would be understood by Arabic-speaking women in Qatar. Subsequently, images, activities, and examples in the intervention manuals were adapted, as needed, to make the content more relevant to Arab culture. To deliver the adapted intervention, 30 Arabic-speaking individuals with mental health backgrounds were trained. The adapted intervention was subsequently pilot-tested with 10 pregnant women receiving prenatal care at Sidra Hospital in Doha. We are now conducting an RCT to examine the effectiveness of the adapted intervention. We plan to enroll 210 pregnant individuals who are Arabic-speaking, with 1:1 randomization to the MB intervention or usual prenatal care. Among the enrolled participants, a stratified subsample of 40 pregnant women with diabetes is being recruited. Data collection will take place at baseline and a 6-month follow-up. The primary outcomes are depressive and anxiety symptoms and perceived stress. Diabetes self-care is the exploratory outcome for the subsample of individuals with diabetes. Intervention implementation will be assessed via client and provider surveys during and after intervention delivery. Power and sample size were calculated using a 2-sided 5% effort rate and assumed analyses on the individual level, accounting for attrition of 20%.ResultsThe cultural adaptation and pilot study of the adapted MB intervention are completed. A total of 157 women have been enrolled in the RCT as of March 31, 2023.ConclusionsThis study is highly innovative, as it is the first study to our knowledge to examine the effectiveness of an evidence-based postpartum depression preventive intervention in the Middle East. Limitations include a single follow-up time point and a small subsample of individuals with diabetes.Trial registrationClinicalTrials.gov NCT04442529; https://www.clinicaltrials.gov/study/NCT04442529.International registered report identifier (irrid)DERR1-10.2196/11623.

Project description:Background: Children and youth are facing three major challenges: (1) poor mental health, (2) physical inactivity, and (3) lack of school readiness. Fundamental movement skills (FMS) and social-emotional learning (SEL) are two developmental domains that are associated with each of these challenges. Currently, there is little focus on interventions that target both FMS and SEL. Thus, the purposes of this study were to: (1) examine the acceptability and feasibility of an FMS and SEL program (Move 2 Smile) and (2) assess the impact of Move 2 Smile on FMS and SEL in children. Methods: An exploratory, pilot study using a within-subjects design was conducted. Descriptive statistics were computed to assess the acceptability and feasibility of the Move 2 Smile program. Changes in FMS and SEL were analyzed using a paired sample t-test. A focus group was conducted with parents to gain feedback after the program ended. Results: Eleven children (four girls; M age = 50.56 months, SD = 8.63) participated, with families attending 80% of the sessions. The children and parents rated the enjoyment of the program 4.1/5 and 4.7/5, respectively. The instructor rated the children's perceived enjoyment 4.6/5 and feasibility of the sessions 4.7/5. Parents engaged in the FMS take-home activities once per week and the SEL activities three times per week. The intervention had a non-significant small to medium effect on FMS (d z = 0.42, p = 0.19), a significant large effect on social skills (d z = 1.38, p = 0.001) and emotion expressiveness (d z = 0.79, p = 0.03), and a non-significant small to medium effect on emotion knowledge (d z = 0.58, p = 0.10) and emotion regulation (d z = 0.44, p = 0.17). The results from the focus group suggest that parents and children enjoyed the program and that the program was useful and effective at impacting FMS and SEL. Conclusions: This intervention is one of the first to intentionally target both FMS and SEL. Children, parents, and instructors deemed this program as acceptable and feasible. These preliminary findings warrant future evaluations of Move 2 Smile, including a randomized controlled trial.

Project description:BackgroundExercise has been shown to be beneficial for people with Parkinson's (PwP), slowing the rate of decline of motor and nonmotor symptoms, with emerging evidence associating exercise with a neuroprotective effect. Current exercise provision is time-limited, and delivered in the absence of strategies to support long-term adherence to exercise. With a growing Parkinson's population, there is a need to develop long-term sustainable approaches to exercise delivery. The primary aim of this study is to assess the feasibility and acceptability of a multicomponent intervention (PDConnect) aimed at promoting physical activity, and self-management for PwP.MethodsA convergent fixed parallel mixed methods design study will be undertaken. The study aims to recruit 30 PwP, who will be randomly allocated into two groups: (i) the usual care group will receive physiotherapy once a week for six weeks delivered via Microsoft Teams. (ii) The PDConnect group will receive physiotherapy once a week for six weeks which combines exercise, education and behaviour change interventions delivered by NHS Parkinson's specialist physiotherapists via Microsoft Teams. This will be followed by 12 weekly sessions of group exercise delivered on Microsoft Teams by fitness instructors specially trained in Parkinson's. Participants will be then contacted by the fitness instructors once per month for three months by video conferencing to support exercise engagement. Primary feasibility data will be collected during the study, with acceptability assessed via semi-structured interviews at the end. Secondary outcomes encompassing motor, non-motor and health and well-being measures will be assessed at baseline, at six, 18, and 30 weeks.DiscussionThis pilot study will establish whether PDConnect is feasible and acceptable to PwP. This will provide a platform for a larger evaluation to assess the effectiveness of PDConnect at increasing exercise participation and self-management within the Parkinson's Community.Trial registrationRegistered on ISRCTN (ISRCTN11672329, 4th June 2020).

Project description:BackgroundThis study aims to evaluate the feasibility and acceptability of the PhunkyFoods Programme, a primary school-based intervention to promote healthy nutrition and physical activity knowledge and behaviours to assess outcomes to inform a phase 3 trial.MethodsThe cluster randomised feasibility trial recruited eight primary schools from the North of England. Elibility criteria included all primary schools in one town, excluding independent and special schools and schools that comprised of only key stage 2 pupils (years 3-6). Eight schools agreed to participate. Randomisation to intervention or control arms was in a 1:1 ratio. Intervention schools received PhunkyFoods over 17 months. Control schools continued with usual curriculum. Assessors were blinded to group assignment. Measures comprised of a Healthy Lifestyle Knowledge Questionnaire and Synchronised Nutrition and Activity Program to assess diet and physical activity, height, weight, and psychological wellbeing. Feasibility outcomes were recruitment, attrition rates, interviews with teaching staff, focus groups with pupils to explore the acceptability of outcome measures, implementation, intervention content, and programme fidelity.ResultsThree hundred fifty-eight pupils, aged 6-9 years from eight schools were recruited at baseline (control n = 170, intervention n = 188); 337 (94.1%) at 6 months (control n = 163, intervention n = 181); and 331 (92.5%) at 18 months (control n = 152, intervention n = 179), and 6 pupils opted out. Trends in increased knowledge of healthy lifestyle behaviours, healthier eating, and liking of fruit and vegetables were reported in the intervention compared to the control group. Year 4 intervention pupils had significantly higher healthy balanced diet knowledge scores compared to control pupils, mean difference 5.1 (95% CI 0.1 to 10.1, p=0.05). At 18 months, the mean percentage of vegetables liked was higher (intervention 53.9% vs. 43.0% control). Similarly, percentage of fruits liked was also higher (intervention 76.9% vs. 67.2% control). Qualitative data showed that delivery of the intervention was feasible and acceptable to teachers and pupils. Lessons were learned to inform the phase 3 trial around the dietary assessment measure and timing of recruitment.ConclusionsWhilst the study was not powered to detect a definitive effect, results suggest a potential to increase knowledge of healthy lifestyle behaviours and dietary behaviours, suggesting that with minor changes, a phase 3 trial is likely to be deliverable.Trial registrationISRCTN, ISRCTN15641330. Registered 8 May 2015-retrospectively registered, 10.1186/ISRCTN15641330.

Dataset Information

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.

Publications

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.

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