NCT04378894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

May 5, 2020

Last Update Submit

September 17, 2020

Conditions

Keywords

MOCEP, Parenting, Saudi Arabia

Outcome Measures

Primary Outcomes (3)

  • 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

  • Better Parenting Questionnaire

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

    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.

    25 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

MOCEP

EXPERIMENTAL

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

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.

Behavioral: MOCEP

Interventions

MOCEPBEHAVIORAL

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

MOCEPWaitlist Control Group

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • No signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman and Child Association

Riyadh, 11516, Saudi Arabia

Location

Study Officials

  • majid aljeraisy, PHD

    riyadh , saudi arabia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized wait-list controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of pediatrics infectious Diseases

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

September 1, 2019

Primary Completion

March 30, 2020

Study Completion

December 30, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations