Health BehaviorNCT03040154
Engaging Immigrants in Preventive Parenting Interventions
A study testing Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)" in people with Health Behavior and Parenting, run by Children's Hospital Los Angeles.
Trial summary
The objective of this community-based randomized controlled trial is to evaluate the outcomes of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at promoting the participation of Filipino parents and grandparents in an evidence-based preventive parenting intervention. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Parenting, Social Acceptance
- What is being tested?
- Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The sample will consist of Filipino parents and grandparents of children/grandchildren between ages 6-12 years old. Inclusion criteria include:
- the parent or grandparent has at least one child between 6 to 12 years of age
- the participating parent/grandparent is Filipino
- At least one parent/grandparent is willing to complete pre and post surveys and watch a brief video
- the parent/grandparent is age 18 or older
- English fluency
Who cannot join
- Younger than 18 years of age
- Does not speak English
- Target child has a developmental disability such as Trisomy 21 or autism
- Parent or grandparent plans to move out of the area within the next nine months
About this study
The objective of this community-based randomized controlled trial is to evaluate the outcomes of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at promoting the participation of Filipino parents and grandparents in an evidence-based preventive parenting intervention.
Read the detailed description
Data will be obtained using pre and post surveys with self-report instruments and enrollment logs. It is hypothesized that 1) Parents and grandparents in the Intervention Arm will demonstrate greater behavioral outcomes (intention to enroll, actual enrollment, and participation in parenting intervention sessions) than those in the Control Arm. 2) Parents and grandparents in the Intervention Arm will show greater improvements from baseline in parent determinants (knowledge, beliefs, attitudes, benefits, and barriers) compared to the Control Arm. 3) Parents' intention to enroll, and actual enrollment in IY will be predicted by the study arm and parent determinants. This study is expected to have an important impact on the uptake of evidence-based parenting interventions among hard-to-reach populations and holds the promise of eliminating disparities in behavioral health outcomes in this understudied and growing minority population.
- Conditions
- Health Behavior, Parenting, Social Acceptance
- Being tested
- Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)", Usual Care Video that is publicly available
- Keywords
- Filipino
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"Other
Also called Intervention Arm
Usual Care Video that is publicly availableOther
Also called Control Arm
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders Receives: Other: Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)" |
| Control Arm | Other | Usual care video publicly available describing the evidence-based parenting intervention Receives: Other: Usual Care Video that is publicly available |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in Evidence-Based Parenting Program
The number of participants from each arm who enrolled in the Incredible Years Parenting Program after completing this study. Enrollment in the parenting program helped determine if the culturally-tailored video intervention effectively increases program participation among Filipino parents.
Measured: Up to two years after completing the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Javier, Children's Hospital Los Angeles
- Investigators
- Joyce R. Javier, MD, MPH, MS, Principal investigator, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040154
- Sponsor's protocol ID
- CCI-13-00159
- Status last verified
- Oct 2023
- First submitted
- 31 Jan 2017
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Javier JR, Coffey DM, Palinkas LA, Kipke MD, Miranda J, Schrager SM. Promoting Enrollment in Parenting Programs Among a Filipino Population: A Randomized Trial. Pediatrics. 2019 Feb;143(2):e20180553. doi: 10.1542/peds.2018-0553.
PubMed 30679379
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Immigrants in Preventive Parenting Interventions
- ClinicalTrials.gov ID
- NCT03040154
- Acronym / sponsor ID
- CCI-13-00159
- Conditions
- Health Behavior, Parenting, Social Acceptance
- Keywords
- Filipino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this community-based randomized controlled trial is to evaluate the outcomes of a theory-based parent engagement intervention (i.e., culturally-tailored video) aimed at promoting the participation of Filipino parents and grandparents in an evidence-based preventive parenting intervention.
Detailed description
Data will be obtained using pre and post surveys with self-report instruments and enrollment logs. It is hypothesized that 1) Parents and grandparents in the Intervention Arm will demonstrate greater behavioral outcomes (intention to enroll, actual enrollment, and participation in parenting intervention sessions) than those in the Control Arm. 2) Parents and grandparents in the Intervention Arm will show greater improvements from baseline in parent determinants (knowledge, beliefs, attitudes, benefits, and barriers) compared to the Control Arm. 3) Parents' intention to enroll, and actual enrollment in IY will be predicted by the study arm and parent determinants. This study is expected to have an important impact on the uptake of evidence-based parenting interventions among hard-to-reach populations and holds the promise of eliminating disparities in behavioral health outcomes in this understudied and growing minority population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders |
| Control Arm | Other | Other: Usual Care Video that is publicly availableUsual care video publicly available describing the evidence-based parenting intervention |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The sample will consist of Filipino parents and grandparents of children/grandchildren between ages 6-12 years old. Inclusion criteria include:
Key exclusion criteria (4 listed)
- Younger than 18 years of age
- Does not speak English
- Target child has a developmental disability such as Trisomy 21 or autism
- Parent or grandparent plans to move out of the area within the next nine 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 |
|---|---|---|
| Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"Also: Intervention Arm | Other | Intervention Arm |
| Usual Care Video that is publicly availableAlso: Control Arm | Other | Control Arm |
Primary outcome
Enrollment in Evidence-Based Parenting Program
Time frame: Up to two years after completing the survey
The number of participants from each arm who enrolled in the Incredible Years Parenting Program after completing this study. Enrollment in the parenting program helped determine if the culturally-tailored video intervention effectively increases program participation among Filipino parents.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30679379Javier JR, Coffey DM, Palinkas LA, Kipke MD, Miranda J, Schrager SM. Promoting Enrollment in Parenting Programs Among a Filipino Population: A Randomized Trial. Pediatrics. 2019 Feb;143(2):e20180553. doi: 10.1542/peds.2018-0553.
- Individual participant dataSharing planned: No
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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.
Joyce R. Javier, MD, MPH, MS principal investigator
Children's Hospital Los Angeles, University of Southern California Keck School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)" in people with Health Behavior and Parenting, run by Children's Hospital Los Angeles.
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 6 inclusion and 4 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment in Evidence-Based Parenting Program (time frame: Up to two years after completing the survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040154, which also lists 1 linked publication.
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 11 Oct 2023.