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ParentingMOCEPNCT04378894

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

A study testing MOCEP in people with Parenting, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Parenting
What is being tested?
MOCEP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSaudi Arabia
Study dates
1 Sep 2019to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • No signed consent

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site
  • Woman and Child Association

    Riyadh, 11516

Other trials in Saudi Arabia

About this study

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

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.

Read the 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.

Conditions
Parenting
Being tested
MOCEP
Keywords
MOCEP, Parenting, Saudi Arabia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOCEPBehavioural

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

Study groups in NCT04378894
Study groupRoleWhat they receive
MOCEPExperimentalMOCEP is implemented over a period of 25 weeks, through weekly group meetings that last approximately three hours.
Receives: Behavioral: MOCEP
Waitlist Control GroupActive comparatorFor 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.
Receives: Behavioral: MOCEP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 25 weeks

  2. Better Parenting Questionnaire

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

    Measured: 25 weeks

  3. 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.

    Measured: 25 weeks

Secondary outcomes (4)
  1. Social-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)

    Parent report measure assesses children's emotional and conduct problems, hyperactivity, and peer relations.

    Measured: 25 weeks

  2. Parenting Stress Index (PSI)

    36-item questionnaire that measures maternal perceptions of stress in the role of a parent.

    Measured: 25 weeks

  3. 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.

    Measured: 25 weeks

  4. 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.

    Measured: 25 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2020
  2. Study start1 Sep 2019
  3. Primary completion30 Mar 2020
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized wait-list controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378894
Sponsor's protocol ID
RC17/259/R
Acronym
MOCEP
Status last verified
Sep 2020
First submitted
5 May 2020
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing MOCEP in people with Parenting, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disciplinary Style Questionnaire (time frame: 25 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.

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