- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06080139
Supporting Refugee Parenting Community and Family Mental Health in Tijuana
A Community-based Participatory Study to Support Parenting and Improve Family Mental Health in Refugee Shelters in Tijuana, Mexico
The goal of this study is to better understand and support parenting practices and family mental health among migrant parents in Tijuana, Mexico. the main questions it aims to answer are:
- What parenting skills are most needed for learning?
- How can we teach them in a participatory way respecting cultural values and norms?
- How does this parenting program affect parental and child interactions and mental health?
Participants will
- have the opportunity to give their opinions on the priority parenting skills needed and on which curriculum to use for learning these skills;
- participate in small group learning sessions twice a week for 4 weeks;
- be asked to complete a few surveys before and after the learning sessions, and 2 months after they complete the learning sessions.
Researchers will compare parents randomly assigned to parenting sessions group with waitlist control group (starting learning sessions 1 month later) to see if the group learning benefits parent-child interactions, parental stress, and parental confidence in parenting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Month 1:
The researchers will use a participatory research model to convene focus groups engaging community stakeholders in two large shelters in Tijuana to prioritize 3-5 parenting skills.
Month 2:
The researchers will recruit participating parents until reaching a sample size of 120, divided into 8 groups of 15. All participants will vote for 1-2 interventions from a list of 5 to revise and adapt to the local context through small group discussions and consensus building.
Month 3:
Participants will complete baseline questionnaires anonymously. Half of the participants (Group 1, N=60) will be randomized to receive the adapted learning curriculum in groups of 15, twice a week for 4 weeks. At the conclusion of month 3, all participants will complete the same questionnaires as pre-intervention. These data will serve as post-intervention data for Group 1 and a second baseline for the remaining participants (Group 2). During month 3, Group 2 will receive a two-page handout on childhood nutrition in Spanish. They will serve as the "control group" for the first wave of intervention.
Month 4:
Group 2 will receive the same intervention as group 1 in month 3. At the conclusion of month 4, participants will complete the same questionnaires as pre-intervention. They will also complete open-ended feedback interviews.
Month 5:
Researchers will analyze all anonymous data and share preliminary results with the community through peer leaders.
Month 6-7:
Researchers will conduct a phone follow-up for all available participants (2 months post intervention) and collect data anonymously.
Month 8:
Researchers will again analyze the aggregate data and share results with the community.
Month 9:
Researchers will draft a manuscript, share final results with the community and nonprofit/academic partners.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baja California
-
Tijuana, Baja California, Mexico, 22526
- Canyon Nest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all consenting parents staying at refugee shelters in Tijuana
Exclusion Criteria:
- known date of leaving Tijuana in less than 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: parenting sessions group
This arm will receive a culturally adapted parenting curriculum twice a week for 4 weeks during month 3 of the study
|
Parents will vote for one of the 5 previously studied refugee parenting curriculums: 1) Creating Opportunities Through Mentoring Parenting Involvement and Safe Space (COMPASS); 2) GenerationPMTO; 3) Happy Families; 4) Family Strengthening Intervention for Refugees (FSI-R). Researchers will use a model of Learning by Observing and Pitching In (LOPI), to empower community members in the learning process. LOPI is a multicomponent way of organizing group learning that improves collaboration, alertness, and executive functions such as perspective-taking and self-regulation in addition to specific skills learning and has been used in many indigenous and indigenous-heritage communities of the Americas. |
|
Active Comparator: waitlist control group
This arm will receive a handout about parenting techniques in Spanish during month 3.
They then receive the same parenting curriculum during month 4.
|
Parents will vote for one of the 5 previously studied refugee parenting curriculums: 1) Creating Opportunities Through Mentoring Parenting Involvement and Safe Space (COMPASS); 2) GenerationPMTO; 3) Happy Families; 4) Family Strengthening Intervention for Refugees (FSI-R). Researchers will use a model of Learning by Observing and Pitching In (LOPI), to empower community members in the learning process. LOPI is a multicomponent way of organizing group learning that improves collaboration, alertness, and executive functions such as perspective-taking and self-regulation in addition to specific skills learning and has been used in many indigenous and indigenous-heritage communities of the Americas. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
parenting knowledge
Time Frame: immediately before intervention and after 4-week intervention period
|
20 multiple choice questions (scores 0-20)
|
immediately before intervention and after 4-week intervention period
|
|
Child behavior and parental efficacy
Time Frame: immediately before intervention and after 4-week intervention period
|
Child Adjustment and Parent Efficacy Scale (total scores 0-81, parental efficacy scores 19-190)
|
immediately before intervention and after 4-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observed parent-child interactions
Time Frame: immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
|
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes
|
immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
|
|
parental stress
Time Frame: immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
|
Parent Stress Index-Short Form21
|
immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
|
|
Qualitative feedback
Time Frame: after 4-week intervention period and at 2-month post-intervenion follow-up
|
semi-structure interviews on program feedback and future suggestions
|
after 4-week intervention period and at 2-month post-intervenion follow-up
|
|
parenting knowledge
Time Frame: post intervention and at 2-month post-intervenion follow-up
|
20 multiple choice questions (scores 0-20)
|
post intervention and at 2-month post-intervenion follow-up
|
|
Child behavior and parental efficacy
Time Frame: post interventionand and at 2-month post-intervenion follow-up
|
Child Adjustment and Parent Efficacy Scale (total scores 0-81, parental efficacy scores 19-190)
|
post interventionand and at 2-month post-intervenion follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xinshu She, MD, MPH, Stanford University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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