Clinical trial NCT04378894: Evaluation of the Mother-Child Educational Program (MOCEP) in Riyadh, Saudi Arabia.
Official title: Randomized Controlled Trial and Process Evaluation of the Mother-Child Educational Program (MOCEP) in Riyadh, Saudi Arabia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Keywords: MOCEP, Parenting, Saudi Arabia
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2020-05-07
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized wait-list controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disciplinary Style Questionnaire
timeFrame: 25 weeks
measure: Better Parenting Questionnaire
timeFrame: 25 weeks
measure: International Development and Early Learning Assessment (IDELA)
timeFrame: 25 weeks
Secondary outcomes:
measure: Social-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)
timeFrame: 25 weeks
measure: Parenting Stress Index (PSI)
timeFrame: 25 weeks
measure: Individual Distress Assessment (IDA)
timeFrame: 25 weeks
measure: Father Involvement Questionnaire (FIQ)
timeFrame: 25 weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Woman and Child Association
Study officials:
affiliation: riyadh , saudi arabia
name: majid aljeraisy, PHD
role: STUDY_CHAIR
References: