Mother and Child Education Program in Palestinian Refugee Camps

• ClinicalTrials.gov Identifier: NCT02402556
• Recruitment Status: Completed
• First Posted: March 30, 2015
• Last Update Posted: December 2, 2016
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Parenting	Behavioral: MOCEP	Not Applicable

Detailed Description:

The purpose of the evaluation study is to rigorously evaluate the impact of MOCEP on child and parent outcomes among Palestinian refugees in Beirut, Lebanon. This evaluation employs an innovative, mixed-methods bio-behavioral approach to investigate the associations among social contexts; maternal, child and family functioning; and reduction in violence through the promotion of harmonious family relationships. The results of this study have implications for improving the lives of and reducing violence for the hundreds of thousands of families with young children living in fragile contexts. We hypothesize that when MOCEP is implemented with fidelity (i.e., delivered as intended by design), participating families will experience reduced violence in their homes and have better individual and intra-family outcomes than families who do not participate in the program.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Implementation and Impact Evaluation of the Mother and Child Education Program (MOCEP) Among Children and Families in Palestinian Refugee Camps in Beirut, Lebanon
• Study Start Date: May 2014
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: MOCEP; MOCEP is implemented over a period of 25 weeks, through weekly group meetings that last approximately three hours.	Behavioral: MOCEP; Through parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing.
Active Comparator: Waitlist Control Group; 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; Through parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing.

Outcome Measures

Primary Outcome Measures :

1. 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
2. Better Parenting Questionnaire [ Time Frame: 25 weeks ]
   11 Item questionnaire that measures parental knowledge, attitudes and practices regarding education and learning, child development and discipline / child rearing.

Secondary Outcome Measures :

1. Socio-Emotional Status: Strengths and Difficulties Questionnaire (child assessment) [ Time Frame: 25 weeks ]
   Parent report measure assesses children's emotional and conduct problems, hyperactivity, and peer relations.
2. Parental Stress Index [ Time Frame: 25 weeks ]
   Assessment of maternal stress
3. Duke Social Support Index [ Time Frame: 25 weeks ]
   Addresses social support in two domains: social interaction and subjective support

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Contacts and Locations

Locations

Lebanon

Bourj el-Barajneh refugee camp

Beirut, Lebanon

Charila

Beirut, Lebanon

Mar Elias Refugee Camp

Beirut, Lebanon

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: James Leckman, MD; Yale University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02402556
• Other Study ID Numbers: 1403013605
• First Posted: March 30, 2015
• Last Update Posted: December 2, 2016
• Last Verified: December 2016