Clinical trial NCT06080139: Supporting Refugee Parenting Community and Family Mental Health in Tijuana
Official title: A Community-based Participatory Study to Support Parenting and Improve Family Mental Health in Refugee Shelters in Tijuana, Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refugee Health
Keywords: parenting
parental mental health
child behavior
prevention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Universidad Iberoamericana
name: PILA Global
name: Fulbright
First posted: 2023-10-12
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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 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.

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.

Eligibility criteria: Inclusion Criteria:

* all consenting parents staying at refugee shelters in Tijuana

Exclusion Criteria:

* known date of leaving Tijuana in less than 3 months

Primary outcomes:
measure: parenting knowledge
timeFrame: immediately before intervention and after 4-week intervention period
measure: Child behavior and parental efficacy
timeFrame: immediately before intervention and after 4-week intervention period
Secondary outcomes:
measure: Observed parent-child interactions
timeFrame: immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
measure: parental stress
timeFrame: immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
measure: Qualitative feedback
timeFrame: after 4-week intervention period and at 2-month post-intervenion follow-up
measure: parenting knowledge
timeFrame: post intervention and at 2-month post-intervenion follow-up
measure: Child behavior and parental efficacy
timeFrame: post interventionand and at 2-month post-intervenion follow-up
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Canyon Nest
state: Baja California
Study officials:
affiliation: Stanford University
name: Xinshu She, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: