Refugee HealthNCT06080139
Supporting Refugee Parenting Community and Family Mental Health in Tijuana
A study testing Refugee parenting education in a participatory community in people with Refugee Health, run by Stanford University at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Refugee Health
- What is being tested?
- Refugee parenting education in a participatory community
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteMexico
- Study dates
- 6 Feb 2024to 23 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all consenting parents staying at refugee shelters in Tijuana
Who cannot join
- known date of leaving Tijuana in less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Refugee Health
- Being tested
- Refugee parenting education in a participatory community
- Keywords
- parenting, parental mental health, child behavior, prevention
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refugee parenting education in a participatory communityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Refugee parenting education in a participatory community |
What is being measured
The primary outcome is the main question the study is designed to answer.
parenting knowledge
20 multiple choice questions (scores 0-20)
Measured: 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)
Measured: immediately before intervention and after 4-week intervention period
Secondary outcomes (5)
Observed parent-child interactions
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes
Measured: immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
parental stress
Parent Stress Index-Short Form21
Measured: immediately before intervention, after 4-week intervention period, and 2-month post-intervenion follow-up
Qualitative feedback
semi-structure interviews on program feedback and future suggestions
Measured: after 4-week intervention period and at 2-month post-intervenion follow-up
parenting knowledge
20 multiple choice questions (scores 0-20)
Measured: post intervention and at 2-month post-intervenion follow-up
Child behavior and parental efficacy
Child Adjustment and Parent Efficacy Scale (total scores 0-81, parental efficacy scores 19-190)
Measured: post interventionand and at 2-month post-intervenion follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start6 Feb 2024
- Primary completion30 May 2024
- Study completion23 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refugee HealthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Iberoamericana, PILA Global, Fulbright
- Responsible party
- Principal investigator, Xinshu She, MD, MPH, Stanford University
- Investigators
- Xinshu She, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080139
- Sponsor's protocol ID
- 69854
- Status last verified
- Jul 2024
- First submitted
- 22 Aug 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no individual data after completion of the data collection. All data will be anonymous and analyzed as collective data.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Participatory Study to Support Parenting and Improve Family Mental Health in Refugee Shelters in Tijuana, Mexico
- ClinicalTrials.gov ID
- NCT06080139
- Acronym / sponsor ID
- 69854
- Conditions
- Refugee Health
- Keywords
- parenting, parental mental health, child behavior, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Universidad Iberoamericana, PILA Global, Fulbright
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| parenting sessions group | Experimental | Behavioral: Refugee parenting education in a participatory communityThis arm will receive a culturally adapted parenting curriculum twice a week for 4 weeks during month 3 of the study |
| waitlist control group | Active comparator | Behavioral: Refugee parenting education in a participatory communityThis arm will receive a handout about parenting techniques in Spanish during month 3. They then receive the same parenting curriculum during month 4. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all consenting parents staying at refugee shelters in Tijuana
Key exclusion criteria (1 listed)
- known date of leaving Tijuana in less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Refugee parenting education in a participatory communityParents 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. | Behavioural | parenting sessions group, waitlist control group |
Primary outcome
parenting knowledge
Time frame: immediately before intervention and after 4-week intervention period
20 multiple choice questions (scores 0-20)
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)
5 secondary outcomes
Observed parent-child interactions
Time frame: 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
Qualitative feedback
Time frame: 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
Child behavior and parental efficacy
Time frame: post interventionand and at 2-month post-intervenion follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Stanford link to study description and contactLink provided by the sponsor.
- Individual participant dataSharing planned: No. There will be no individual data after completion of the data collection. All data will be anonymous and analyzed as collective data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinshu She, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Refugee parenting education in a participatory community in people with Refugee Health, run by Stanford University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parenting knowledge (time frame: immediately before intervention and after 4-week intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.