跳至主要内容
临床试验/NCT04378894
NCT04378894Unknown不适用

Randomized Controlled Trial and Process Evaluation of the Mother-Child Educational Program (MOCEP) in Riyadh, Saudi Arabia.

King Abdullah International Medical Research Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Disciplinary Style Questionnaire

研究概览

简要总结

The Mother Child Education Program (MOCEP) was developed by the Mother Child Education Foundation (ACEV). MOCEP is implemented in Saudi Arabia through a 25-week program conducted by ACEV-trained groups with a curriculum for the child that is implemented at home by the mothers. The program is designed to (1) promote parenting skills and bolster strategies that support school readiness among mothers of 3-to-6- year-old children, and (2) enhance social cohesion in the family and community. Rigorous evaluations of MOCEP have been conducted in several contexts, but not yet in the context of Saudi Arabia. Thus, the present study aims to rigorously evaluate the impact of MOCEP on child and parent outcomes among families in Riyadh, Saudi Arabia.

详细描述

The problem and its importance: According to an estimate two hundred million or a third of the world's youngest children do not achieve their potential due to lack of stimulating, nurturing, safe, and responsive caregiving. The importance of caregiving cannot be underestimated for early child development (Engle et al.,2007). However, parents and caregivers need to be supported in fulfilling this role. The results from parenting programs, across high-, middle and low-income countries indicate significant trends in obtaining positive results for parents and children (MOCEP).

In Saudi Arabia, youth represents almost 50% of the population and those < 5 years of age account for 10.6% (GaStat, 2019). As for the crude birth rate among the Saudi population, it hits 17.23 live children for every 1,000 persons. Thus, the government has stressed the importance of investing in national programs that focus on childhood within the scope of the 2030 vision. MOCEP was implemented in Saudi Arabia by the Child Care Association (CCA) which is an NGO established in 2006. The CCA's main objective is to promote Early Child Development (ECD) through the MOCEP since 2011.

The purpose of the present evaluation study--a collaboration between CCA and KAIMRC--is to evaluate the impact of MOCEP on child and parent outcomes among families in Riyadh, Saudi Arabia, using a randomized wait-list controlled trial. Specifically, the aim of the study is to empirically assess the impact of MOCEP on maternal and child outcomes and to explore key moderators of the programmatic impact including characteristics of the program implementation and contextual characteristics.

Specific Objective 1: We will characterize the impact of MOCEP on child outcomes including executive function, social-emotional skills, and cognitive skills such as emergent numeracy, literacy and verbal skills.

Specific Objective 2: We will characterize the impact of MOCEP on parental knowledge, attitudes, practices, and skills.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The mothers in the control group will take a special awareness program but not MOCEP and the participant, the care providers and the investigators are masked.

入排标准

年龄范围
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Mothers must have at least one child between 3 and 6 years of age.
  • •Mothers must be literate.
  • •Mothers must be living in the designated implementation areas in Riyadh, Saudi Arabia.
  • •Mothers must agree to attend the MOCEP program and complete questionnaires at the beginning and the end of the program

排除标准

  • •No signed consent

研究组 & 干预措施

MOCEP

Experimental

MOCEP is implemented over a period of 25 weeks, through weekly group meetings that last approximately three hours.

干预措施: MOCEP (Behavioral)

Waitlist Control Group

Active Comparator

For ethical reasons, no one recruited will be excluded from the opportunity to benefit from the intervention. MOCEP group will be the primary intervention group and the second group will act as the wait-listed control group. Families in the wait-listed control group will participate in a special awareness program but not MOCEP. Although the families in the wait-listed control group will start as a control group (not receiving the intervention), they will have the opportunity to participate in the intervention in a later round of implementation, after the intervention group has completed the program.

干预措施: MOCEP (Behavioral)

结局指标

主要结局

Disciplinary Style Questionnaire

时间窗: 25 weeks

Parent report measure of parental disciplinary style assesses the frequency with which parents engage in seven forms of discipline when dealing with children's undesirable behavior

Better Parenting Questionnaire

时间窗: 25 weeks

11-item questionnaire that measures responsive parenting as reported by the mother

International Development and Early Learning Assessment (IDELA)

时间窗: 25 weeks

An, easy-to-use, rigorous global tool that measures children's early learning and development of children from 3.5 to 6 years of age.

次要结局

  • Social-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)(25 weeks)
  • Parenting Stress Index (PSI)(25 weeks)
  • Individual Distress Assessment (IDA)(25 weeks)
  • Father Involvement Questionnaire (FIQ)(25 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Muneef

professor of pediatrics infectious Diseases

King Abdullah International Medical Research Center

研究点 (1)

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