Evaluation of the Mother-Child Educational Program (MOCEP) in Riyadh, Saudi Arabia.

Parenting Clinical Trial

— MOCEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04378894
• Other study ID #: RC17/259/R
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: September 2020
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

A comprehensive sociodemographic characterization of participating mothers and children will be conducted. Maternal and child outcomes will be measured before and after the intervention. Maternal outcomes will include knowledge, attitudes, and practices regarding parenting, child development, and education; disciplinary style; wellbeing; social support; and empowerment. Child outcomes will include executive function, social-emotional skills, nutritional status, and school readiness. Mothers will complete a demographic questionnaire at baseline to characterize social, demographic, home, family, and community characteristics. Mothers will also complete a battery addressing parenting and child development-related knowledge, attitudes and practices at baseline and endline.

The assessors will use IDELA which provides a direct measure of children's learning and development and assesses child school readiness through a holistic exploration of children's early literacy, math, problem-solving, social-emotional development, and gross and fine motor skills. The tool is available in Arabic and has been validated in multiple countries.

To assess the social-emotional skills of children, in addition to the IDELA subtest, we will apply the Strengths and Difficulties Questionnaire. This parent-report measure assesses children's emotional and conduct problems, hyperactivity, and peer relations.

The Disciplinary Style Questionnaire (DSQ), a parent-report measure of parental disciplinary style, will be used to assess the frequency with which parents engage in seven forms of discipline when dealing with children's undesirable behavior: inductive discipline, physical punishment, manipulating privileges, harsh verbal discipline, argument, shaming, and ignoring. These outcomes will be measured before and after implementation of the 25 weeks MOCEP program.

Process evaluation:

Program dosage: will be measured by mothers' attendance at training sessions and the number of sessions delivered by group leaders will be collected using attendance sheets.

Program engagement: will be measured by a set of items that will be developed by the Yale study team, based on constructs examined in other studies (Durlak & DuPre, 2008; Reyes et aL, 2012). The tool measuring program engagement will be administered to both parents and group leaders participating in MOCEP.

Program quality: will be measured with observational tools and self-report measures. An ethnographer will be present during the training to document facets such as trainer responsiveness to parents' needs, clarity of delivery, trainer motivation, parent engagement, and group cohesion. Also, supervisors will complete the MOCEP Supervisor's Checklist; supervisors and parents will rate the overall quality of training using items developed by the research team. Finally, MOCEP curriculum worksheets will be used to determine the degree to which mothers deliver the program as intended in their homes.

Data will be collected in paper forms by trained assessors and then entered into a secured electronic database prepared by KAIMRC using the KoBo Toolbox program.

Sample size: We aim to recruit 100 mother-child dyads for the wait-list control and 100 mother-child dyads for the intervention group.

Sampling technique: The target population will be recruited based on the catchment areas for the program in the Riyadh area (convenience sampling). We will randomize the enrolled participants to the intervention and control groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• No signed consent

Related Conditions & MeSH terms

• Parenting

Intervention

Behavioral:
• MOCEP
Through parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing.

Locations

Country	Name	City	State
Saudi Arabia	Woman and Child Association	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center	Yale University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disciplinary Style Questionnaire	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	25 weeks
Primary	Better Parenting Questionnaire	11-item questionnaire that measures responsive parenting as reported by the mother	25 weeks
Primary	International Development and Early Learning Assessment (IDELA)	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.	25 weeks
Secondary	Social-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)	Parent report measure assesses children's emotional and conduct problems, hyperactivity, and peer relations.	25 weeks
Secondary	Parenting Stress Index (PSI)	36-item questionnaire that measures maternal perceptions of stress in the role of a parent.	25 weeks
Secondary	Individual Distress Assessment (IDA)	Mothers are asked to report the extent to which they are currently feeling a number of affects (e.g., frustrated, lonely, anxious) using this 12-item rating scale.	25 weeks
Secondary	Father Involvement Questionnaire (FIQ)	20 items that measure the mothers' perceptions of how her husband interacts with their children, how the mother is treated by her husband, and how her husband interacts with other members of the community.	25 weeks