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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| MOCEP | Experimental | MOCEP is implemented over a period of 25 weeks, through weekly group meetings that last approximately three hours. Receives: Behavioral: MOCEP |
| 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. Receives: Behavioral: MOCEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Better Parenting Questionnaire
11-item questionnaire that measures responsive parenting as reported by the mother
Measured: 25 weeks
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)
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
Parenting Stress Index (PSI)
36-item questionnaire that measures maternal perceptions of stress in the role of a parent.
Measured: 25 weeks
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
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.
- First posted7 May 2020
- Study start1 Sep 2019
- Primary completion30 Mar 2020
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Maha Muneef, King Abdullah International Medical Research Center
- Investigators
- majid aljeraisy, PHD, Study chair, riyadh , saudi arabia
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial and Process Evaluation of the Mother-Child Educational Program (MOCEP) in Riyadh, Saudi Arabia.
- ClinicalTrials.gov ID
- NCT04378894
- Acronym / sponsor ID
- MOCEP / RC17/259/R
- Conditions
- Parenting
- Keywords
- MOCEP, Parenting, Saudi Arabia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized wait-list controlled trial
| Arm | Type | Receives |
|---|---|---|
| MOCEP | Experimental | Behavioral: MOCEPMOCEP is implemented over a period of 25 weeks, through weekly group meetings that last approximately three hours. |
| Waitlist Control Group | Active comparator | Behavioral: MOCEPFor 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- No signed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOCEPThrough parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing. | Behavioural | MOCEP, Waitlist Control Group |
Primary outcome
Disciplinary Style Questionnaire
Time frame: 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
Time frame: 25 weeks
11-item questionnaire that measures responsive parenting as reported by the mother
International Development and Early Learning Assessment (IDELA)
Time frame: 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.
4 secondary outcomes
Social-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)
Time frame: 25 weeks
Parenting Stress Index (PSI)
Time frame: 25 weeks
Individual Distress Assessment (IDA)
Time frame: 25 weeks
Father Involvement Questionnaire (FIQ)
Time frame: 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
majid aljeraisy, PHD study chair
riyadh , saudi arabia
1 site in 1 country: see every site and its status.
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.