Supporting Refugee Parenting Community and Family Mental Health in Tijuana
NCT ID: NCT06080139
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2024-02-06
2024-06-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. What parenting skills are most needed for learning?
2. How can we teach them in a participatory way respecting cultural values and norms?
3. How does this parenting program affect parental and child interactions and mental health?
Participants will
1. have the opportunity to give their opinions on the priority parenting skills needed and on which curriculum to use for learning these skills;
2. participate in small group learning sessions twice a week for 4 weeks;
3. 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prepared Parents Helping Kids
NCT03719976
Engaging Immigrants in Preventive Parenting Interventions
NCT03040154
Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand
NCT01668992
Evaluating a Strengths-based Community-grounded Intervention
NCT06701240
Pediatric Parenting Support in Flint
NCT03945552
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
parenting sessions group
This arm will receive a culturally adapted parenting curriculum twice a week for 4 weeks during month 3 of the study
Refugee parenting education in a participatory community
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.
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.
Refugee parenting education in a participatory community
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Refugee parenting education in a participatory community
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Iberoamericana
OTHER
PILA Global
UNKNOWN
Fulbright
OTHER
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xinshu She, MD, MPH
Clinical Associate Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xinshu She, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Canyon Nest
Tijuana, Estado de Baja California, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Stanford link to study description and contact
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69854
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.