Supporting Refugee Parenting Community and Family Mental Health in Tijuana

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06080139
Collaborator
Universidad Iberoamericana (Other), PILA Global (Other), Fulbright (Other)
120
1
2
11
10.9

Study Details

Study Description

Brief Summary

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:

  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 group 1 with group 2 (starting learning sessions 1 month later than group 1) to see if the group learning benefits parent-child interactions, parental stress, and parental confidence in parenting.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Refugee parenting education in a participatory community
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Community-based Participatory Study to Support Parenting and Improve Family Mental Health in Refugee Shelters in Tijuana, Mexico
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Apr 15, 2024
Anticipated Study Completion Date :
Sep 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

This arm will receive a culturally adapted parenting curriculum twice a week for 4 weeks during month 3 of the study

Behavioral: 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.

Active Comparator: Group 2

This arm will receive a handout about parenting techniques in Spanish during month 3. They then receive the same parenting curriculum during month 4.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. parenting knowledge [immediately before intervention and after 4-week intervention period]

    20 multiple choice questions

  2. Child behavior and parental efficacy [immediately before intervention and after 4-week intervention period]

    Child Adjustment and Parent Efficacy Scale

Secondary Outcome Measures

  1. Observed parent-child interactions [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

  2. parental stress [immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up]

    Parent Stress Index-Short Form21

  3. Qualitative feedback [after 4-week intervention period and at 2-month post-intervenion follow-up]

    semi-structure interviews on program feedback and future suggestions

  4. parenting knowledge [post intervention and at 2-month post-intervenion follow-up]

    20 multiple choice questions

  5. Child behavior and parental efficacy [post interventionand and at 2-month post-intervenion follow-up]

    Child Adjustment and Parent Efficacy Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • all consenting parents staying at refugee shelters in Tijuana
Exclusion Criteria:
  • known date of leaving Tijuana in less than 3 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Canyon Nest Tijuana Baja California Mexico 22526

Sponsors and Collaborators

  • Stanford University
  • Universidad Iberoamericana
  • PILA Global
  • Fulbright

Investigators

  • Principal Investigator: Xinshu She, MD, MPH, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Xinshu She, MD, MPH, Clinical Associate Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier:
NCT06080139
Other Study ID Numbers:
  • 69854
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xinshu She, MD, MPH, Clinical Associate Professor of Pediatrics, Stanford University

Study Results

No Results Posted as of Oct 12, 2023