ParentingNCT02402556
Mother and Child Education Program in Palestinian Refugee Camps
A study testing MOCEP in people with Parenting, run by Yale University at 3 sites in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- 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
- 106 participants
- Where
- 3 sitesLebanon
- Study dates
- May 2014to Sep 2016
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Lebanon3 sites
Bourj el-Barajneh refugee camp
Beirut
Charila
Beirut
Mar Elias Refugee Camp
Beirut
About this study
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
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.
Read the 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.
- Conditions
- Parenting
- Being tested
- MOCEP
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. 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. 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 parental knowledge, attitudes and practices regarding education and learning, child development and discipline / child rearing.
Measured: 25 weeks
Secondary outcomes (3)
Socio-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
Parental Stress Index
Assessment of maternal stress
Measured: 25 weeks
Duke Social Support Index
Addresses social support in two domains: social interaction and subjective support
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 posted30 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Leckman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402556
- Sponsor's protocol ID
- 1403013605
- Status last verified
- Dec 2016
- First submitted
- 25 Mar 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32014538
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02402556
- Acronym / sponsor ID
- 1403013605
- Conditions
- Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Mar 2015 (estimated)
- 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 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.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| 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. 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
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 parental knowledge, attitudes and practices regarding education and learning, child development and discipline / child rearing.
3 secondary outcomes
Socio-Emotional Status: Strengths and Difficulties Questionnaire (child assessment)
Time frame: 25 weeks
Parental Stress Index
Time frame: 25 weeks
Duke Social Support Index
Time frame: 25 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Derived from this study: PubMed 32014538Ponguta 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.
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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.
James Leckman, MD principal investigator
Yale University
3 sites 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 Yale University at 3 sites in Lebanon.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402556, which also lists 1 linked publication.
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 2 Dec 2016.