Engaging Immigrants in Preventive Parenting Interventions

• Sponsor: Children's Hospital Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT03040154
• Collaborator: (none)
• Enrollment: 217
• Arms: 2
• Duration (Months): 6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior; Parenting; Social Acceptance	Other: Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"; Other: Usual Care Video that is publicly available	N/A

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

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Engaging Immigrants in Preventive Parenting Interventions
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders	Other: Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"; Other Names: Intervention Arm
Other: Control Arm Usual care video publicly available describing the evidence-based parenting intervention	Other: Usual Care Video that is publicly available; Other Names: Control Arm

Outcome Measures

Primary Outcome Measures

1. Enrollment in Evidence-Based Parenting Program [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• The sample will consist of Filipino parents and grandparents of children/grandchildren between ages 6-12 years old. Inclusion criteria include:

1. the parent or grandparent has at least one child between 6 to 12 years of age

2. the participating parent/grandparent is Filipino

3. At least one parent/grandparent is willing to complete pre and post surveys and watch a brief video

4. the parent/grandparent is age 18 or older

5. English fluency

Exclusion Criteria:

1. Younger than 18 years of age

2. Does not speak English

3. Target child has a developmental disability such as Trisomy 21 or autism

4. Parent or grandparent plans to move out of the area within the next nine months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Hospital Los Angeles

Investigators

• Principal Investigator: Joyce R. Javier, MD, MPH, MS, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joyce Javier, Assistant Professor of Clinical Pediatrics, Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT03040154
• Other Study ID Numbers: CCI-13-00159
• First Posted: Feb 2, 2017
• Last Update Posted: Jun 22, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Joyce Javier, Assistant Professor of Clinical Pediatrics, Children's Hospital Los Angeles: Filipino

Study Results

Participant Flow

Recruitment Details	595 participants were assessed for eligibility. Of these participants, 378 were excluded (221 did not meet inclusion criteria, 157 were not interested).
Pre-assignment Detail	217 participants were initially enrolled (i.e. they were CONSENTED and ASSIGNED to a group). Two participants dropped out before data was collected, which explains the changes from 217 participants who started to 215 participants who completed the study.

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"	Usual care video publicly available describing the evidence-based parenting intervention Usual Care Video that is publicly available
Period Title: Overall Study
STARTED	110	105
COMPLETED	110	105
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Arm	Control Arm	Total
Arm/Group Description	Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"	Usual care video publicly available describing the evidence-based parenting intervention Usual Care Video that is publicly available	Total of all reporting groups
Overall Participants	110	105	215
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.93 (12.32)	45.66 (11.12)	45.80 (11.73)
Sex: Female, Male (Count of Participants)
Female	78 70.9%	86 81.9%	164 76.3%
Male	32 29.1%	19 18.1%	51 23.7%
Relationship to Child (Count of Participants)
Biological Mother	59 53.6%	70 66.7%	129 60%
Biological Father	26 23.6%	13 12.4%	39 18.1%
Adpotive Father	1 0.9%	0 0%	1 0.5%
Stepparent	1 0.9%	1 1%	2 0.9%
Parent's Partner	5 4.5%	3 2.9%	8 3.7%
Other Adult Relative	2 1.8%	4 3.8%	6 2.8%
Other	16 14.5%	14 13.3%	30 14%
Marital Status (Count of Participants)
Never Married	11 10%	6 5.7%	17 7.9%
Living Together	2 1.8%	1 1%	3 1.4%
Married	79 71.8%	86 81.9%	165 76.7%
Separated	6 5.5%	0 0%	6 2.8%
Divorced	7 6.4%	8 7.6%	15 7%
Widowed	5 4.5%	4 3.8%	9 4.2%
Child's Gender (Count of Participants)
Male	51 46.4%	50 47.6%	101 47%
Female	59 53.6%	55 52.4%	114 53%
Income (Count of Participants)
<20,00	29 26.4%	20 19%	49 22.8%
20,000-49,999	42 38.2%	31 29.5%	73 34%
50,000-99,999	28 25.5%	36 34.3%	64 29.8%
>100,00	11 10%	16 15.2%	27 12.6%
Child's Birthplace (Count of Participants)
United States	85 77.3%	85 81%	170 79.1%
Philippines	22 20%	20 19%	42 19.5%
Other	3 2.7%	0 0%	3 1.4%
Education (Count of Participants)
Grades 0-8	1 0.9%	0 0%	1 0.5%
Grades 9-11	0 0%	1 1%	1 0.5%
High School or GED	6 5.5%	8 7.6%	14 6.5%
Some College	22 20%	19 18.1%	41 19.1%
College Graduate	74 67.3%	59 56.2%	133 61.9%
Post-College Graduate	7 6.4%	18 17.1%	25 11.6%
Work Status (Count of Participants)
Full Time	65 59.1%	61 58.1%	126 58.6%
Part Time	21 19.1%	13 12.4%	34 15.8%
Working at Home	2 1.8%	5 4.8%	7 3.3%
Looking for a Job	6 5.5%	14 13.3%	20 9.3%
Not working by choice	16 14.5%	12 11.4%	28 13%
Parent's Birthplace (Count of Participants)
United States	10 9.1%	14 13.3%	24 11.2%
Philippines	99 90%	90 85.7%	189 87.9%
Other	1 0.9%	1 1%	2 0.9%
Primary Home Language (Count of Participants)
English	44 40%	47 44.8%	91 42.3%
Tagalog	40 36.4%	35 33.3%	75 34.9%
Ilocano	2 1.8%	5 4.8%	7 3.3%
Bisaya	6 5.5%	1 1%	7 3.3%
Other	18 16.4%	17 16.2%	35 16.3%
Child's Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.73 (1.95)	8.85 (2.05)	8.79 (1.995)
Perceived Susceptibility to risky sexual activity (Units on a scale) [Mean (Full Range) ]
Mean (Full Range) [Units on a scale]	6.68	7.17	6.91
Perceived Susceptibility to using illegal drugs (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	4.2455	5.4257	4.8104
Perceived Susceptibility to thoughts of suicide (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	4.4091	4.8812	4.6351
Knowledge of Filipino mental health disparities: Suicide (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	2.39	2.45	2.42
Knowledge of Filipino behavioral health disparities: drug use (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	2.75	2.86	2.8

Outcome Measures

1. Primary Outcome

Title	Enrollment in Evidence-Based Parenting Program
Description	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.
Time Frame	Up to two years after completing the survey

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"	Usual care video publicly available describing the evidence-based parenting intervention Usual Care Video that is publicly available
Measure Participants	110	105
Count of Participants [Participants]	27 24.5%	12 11.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Arm, Control Arm
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.67
	Confidence Interval	(2-Sided) 95%; 1.33 to 5.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Through study completion, for up to 6 months
Arm/Group Title	Intervention Arm		Control Arm
Arm/Group Description	Culturally-tailored video that includes parent testimonials, health and mental health clinicians, community-based providers, and church leaders Video Documentary entitled, "Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"		Usual care video publicly available describing the evidence-based parenting intervention Usual Care Video that is publicly available
All Cause Mortality
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/105 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/105 (0%)

Limitations/Caveats

This was conducted in urban populations of Filipinos in Southern California, so findings may not generalize to non-urban or other racial/ethnic populations. Knowledge and susceptibility were also self-reported and subject to social desirability bias.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.