NCT06080139

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. 1.What parenting skills are most needed for learning?
  2. 2.How can we teach them in a participatory way respecting cultural values and norms?
  3. 3.How does this parenting program affect parental and child interactions and mental health?
  4. 4.have the opportunity to give their opinions on the priority parenting skills needed and on which curriculum to use for learning these skills;
  5. 5.participate in small group learning sessions twice a week for 4 weeks;
  6. 6.be asked to complete a few surveys before and after the learning sessions, and 2 months after they complete the learning sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

August 22, 2023

Last Update Submit

July 30, 2024

Conditions

Keywords

parentingparental mental healthchild behaviorprevention

Outcome Measures

Primary Outcomes (2)

  • parenting knowledge

    20 multiple choice questions (scores 0-20)

    immediately before intervention and after 4-week intervention period

  • Child behavior and parental efficacy

    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 Outcomes (5)

  • Observed parent-child interactions

    immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up

  • parental stress

    immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up

  • Qualitative feedback

    after 4-week intervention period and at 2-month post-intervenion follow-up

  • parenting knowledge

    post intervention and at 2-month post-intervenion follow-up

  • Child behavior and parental efficacy

    post interventionand and at 2-month post-intervenion follow-up

Study Arms (2)

parenting sessions group

EXPERIMENTAL

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

waitlist control group

ACTIVE COMPARATOR

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

Interventions

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.

parenting sessions groupwaitlist control group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all consenting parents staying at refugee shelters in Tijuana

You may not qualify if:

  • known date of leaving Tijuana in less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canyon Nest

Tijuana, Estado de Baja California, 22526, Mexico

Location

Related Links

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Xinshu She, MD, MPH

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Pediatrics

Study Record Dates

First Submitted

August 22, 2023

First Posted

October 12, 2023

Study Start

February 6, 2024

Primary Completion

May 30, 2024

Study Completion

June 23, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

There will be no individual data after completion of the data collection. All data will be anonymous and analyzed as collective data.

Locations