A Protocol to Promote Critical Consumption (PCC)

Официальное название

Effectiveness of a Psychoeducational Program to Promote a Critical Attitude Towards the Symbolic Consumption of Yoghurt in Primary School Children: Randomized Clinical Trial

Обзор

The aim of this randomised controlled trial is to evaluate the efficacy of an intervention called a psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children. Specifically, a cluster randomised controlled trial will be conducted in primary schools in Lima, Peru. After informed consent of the tutor psychologists, children and parents, schools will be randomly assigned, in a 1:1 ratio, to the intervention or control group, with a total of 240 fourth grade students and 24 tutor psychologists. The primary and secondary research questions are as follows.

Подробное описание

The aim of this randomised controlled trial is to evaluate the efficacy of an intervention called a psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children.

Specifically, a cluster randomised controlled trial will be conducted in primary schools in Lima, Peru. After informed consent of the tutor psychologists, children and parents, schools will be randomly assigned, in a 1:1 ratio, to the intervention or control group, with a total of 240 fourth grade students and 24 tutor psychologists. The primary and secondary research questions are as follows.

The primary research question:

• Is the intervention effective in fostering critical attitudes towards symbolic yoghurt consumption in children from pre-test to post-test (Record of symbolic consumption responses: self, parent and facilitator reports)?

The secondary research questions:

* Is the intervention effective in stabilising the child's deductive skills? * Is the main question moderated by the child's gender, physical disability, dysfunctional state and the facilitator's experience? The intervention will take place in the school classroom (2 sessions of 1 hour per week) for 3 consecutive weeks, plus a feedback session (1 hour per week); and a further session with parents (1 hour per week). A set of participatory techniques will be included to help distinguish between symbolic and nutritional aspects of yoghurt (e.g. role play), to help understand the persuasive intent of advertising (e.g. opinion wheel), and to help balance between peer pressure consumption and critical attitude. The control group will carry out the usual teaching and will receive the set of activities after the end of the trial. After two interviews with the child and another interview with the parents, the Symbolic Consumption Response Register will be completed, and the Raven's Progressive Matrices Test-2 will be applied before and immediately after the intervention, both in the control group and in the intervention group. The facilitators of both groups will complete a form immediately after the end of each psychoeducational activity for both children and parents Eligibility Criteria Description Additional inclusion criteria for schools are: (a) access to the classroom within the school, and (b) written informed consent for participation in this study by the 4th grade primary school psychologists. Inclusion criteria for children are: (a) enrolled in 4th grade, (b) give informed consent, (c) have written informed consent from their parents or legal guardians, present normal intelligence according to the Raven's Progressive Matrices Test-2.

Вмешательства

• Поведенческое psychoeducational programme to promote a critical attitude towards the symbolic consumption of yoghurt in primary school children
  The promotion of critical consumption in children is to be developed in primary school classrooms. Students will spend a total of 7 hours: (2 sessions of 1 hour per week) for 3 consecutive weeks, plus a feedback session (1 hour per week); and there will be another session with parents (1 hour per week). The psychologist tutor will receive a set of six activities related to discriminating between symbolic and critical yoghurt consumption in children, understanding the persuasive intent of yoghurt

Первичные конечные точки

• Change from the child's initial symbolic consumption at 6 weeks [Срок оценки: Baseline, 6 weeks]
• Change from the child's initial symbolic consumption at 19 weeks [Срок оценки: Baseline, 19 weeks]

Вторичные конечные точки (6)

• Stability of child's deductive ability at 6 weeks [Срок оценки: Baseline, 6 weeks]
• Stability of child's deductive ability at 19 weeks [Срок оценки: Baseline, 19 weeks]
• Children's assessment of the psychoeducational programme [Срок оценки: 6 weeks]
• Child's Sex [Срок оценки: Baseline]
• Assessment of facilitators' performance [Срок оценки: Baseline]
• Children's psychosocial or behavioral dysfunction [Срок оценки: Baseline]

Критерии участия

Критерии включения

For children:

• Enrolled in 4th grade
• Provide informed assent
• Have written informed consent from their parents or legal guardians
• Present normal intelligence according to the Raven's Progressive Matrices Test-2

For schools:

• Provide access to the classroom within the school
• Provide written informed consent for participation from 4th grade primary school psychologists

Критерии исключения

• Not enrolled in 4th grade
• Suffering from a mental disorder
• Repeating 4th grade
• Below normal intelligence according to the Raven-2 Progressive Matrices Test

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Money R, Wilde S, Dawson D. Review: The effectiveness of Theraplay for children under 12 - a systematic literature review. Child Adolesc Ment Health. 2021 Sep;26(3):238-251. doi: 10.1111/camh.12416. Epub 2020 Aug 6. PMID 32767491
• Lebiger-Vogel J, Rickmeyer C, Leuzinger-Bohleber M, Meurs P. Fostering Emotional Availability in Mother-Child-Dyads With an Immigrant Background: A Randomized-Controlled-Trial on the Effects of the Early Prevention Program First Steps. Front Psychol. 2022 Apr 7;13:790244. doi: 10.3389/fpsyg.2022.790244. eCollection 2022. PMID 35465509
• Vanderbilt KE, Andreason C. The influence of popular media characters on children's object choices. Br J Dev Psychol. 2023 Mar;41(1):1-12. doi: 10.1111/bjdp.12434. Epub 2022 Oct 12. PMID 36224492
• Triece P, Massazza A, Fuhr DC. Effectiveness and implementation outcomes for peer-delivered mental health interventions in low- and middle-income countries: a mixed-methods systematic review. Soc Psychiatry Psychiatr Epidemiol. 2022 Sep;57(9):1731-1747. doi: 10.1007/s00127-022-02294-y. Epub 2022 Apr 29. PMID 35484436

Идентификаторы

NCT: NCT06996847 · 001-2025-IDI-FCCTP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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