NCT02402556

Brief Summary

The purpose of the Mother Child Education Program (MOCEP)-a group-based early childhood development parenting education program-is to provide school-readiness and parenting skills to mothers of young children who do not have access to preschool education services. The MOCEP intervention also provides a setting in which caregivers can model pro-social behaviors and practice conflict resolution techniques directly with young children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 2, 2016

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

March 25, 2015

Last Update Submit

December 1, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 parental knowledge, attitudes and practices regarding education and learning, child development and discipline / child rearing.

    25 weeks

Secondary Outcomes (3)

  • Socio-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)

    25 weeks

  • Parental Stress Index

    25 weeks

  • Duke Social Support Index

    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. Although the families in the wait-listed control group will start out 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 - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child must be between 3 and 6 years of age (children age 7 may be accepted under special circumstances)
  • Mother must be able to read and write in Arabic (although skills may not be well-developed)
  • Mothers must commit to participate in the 25-week MOCEP Intervention program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bourj el-Barajneh refugee camp

Beirut, Lebanon

Location

Charila

Beirut, Lebanon

Location

Mar Elias Refugee Camp

Beirut, Lebanon

Location

Related Publications (1)

  • Ponguta LA, Issa G, Aoudeh L, Maalouf C, Hein SD, Zonderman AL, Katsovich L, Khoshnood K, Bick J, Awar A, Nourallah S, Householder S, Moore CC, Salah R, Britto PR, Leckman JF. Effects of the Mother-Child Education Program on Parenting Stress and Disciplinary Practices Among Refugee and Other Marginalized Communities in Lebanon: A Pilot Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2020 Jun;59(6):727-738. doi: 10.1016/j.jaac.2019.12.010. Epub 2020 Jan 31.

Study Officials

  • James Leckman, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 30, 2015

Study Start

May 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 2, 2016

Record last verified: 2016-12

Locations