Implementing a Church-based Parenting Intervention for Hispanics

June 14, 2023 updated by: Jose R Parra-Cardona, University of Texas at Austin

Implementing a Church-based Parenting Intervention to Promote NIDA Prevention Science Among Hispanics

The current investigation consists of the implementation and modest refinements of a culturally adapted version of the evidence-based PT intervention known as GenerationPMTO.© The adapted intervention, CAPAS-Youth, is primarily delivered to parents. The primary research objectives are twofold: a) to conduct refinements of the CAPAS-Youth intervention for Hispanic immigrants in mid-Texas, and b) to measure implementation barriers and precursors, as well as implementation outcomes, in an effort to inform a future study focused on scaling the intervention. A special focus on faith-based organization informs the intervention, as a way of increasing reach with underserved Hispanic immigrant communities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Parent training (PT) interventions constitute the gold standard for strengthening parenting practices that are effective protective factors in the lives of adolescents. However, the availability of efficacious culturally adapted PT interventions in underserved Hispanic communities remains scarce throughout the US. Thus, there is an urgent need in the implementation science (IS) field to identify implementation strategies aimed at addressing service gaps affecting Hispanic populations. The current investigation consists of the implementation and modest refinements of a culturally adapted version of the evidence-based PT intervention known as GenerationPMTO.© Our rationale is that implementing efficacious prevention interventions in faith-based organizations constitutes a key alternative to address service barriers experienced by underserved populations. We also propose that by training lay members of target communities as prevention interventionists, the sustainment of prevention programs can be significantly enhanced. The research aims of this R34 investigation are: (a) To implement a pilot study aimed at refining the CAPAS-Youth curriculum and study procedures, (b) to implement a randomized controlled trial, aimed at empirically testing the efficacy of the CAPAS-Youth intervention with first-generation low-income Hispanic families in Travis County, (c) to measure barriers and facilitators associated with the implementation of the CAPAS-Youth prevention intervention in the target context, and (d) to measure relevant implementation outcomes to inform a future R01 effectiveness trial. The investigation has high public health relevance as it addresses health disparities experienced by populations not adequately served by existing systems of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • Steve Hicks School of Social Work, the University of Texas at Austin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Parent Inclusion Criteria:

  • 18 years or older.
  • Living in a one or two-parent family household.
  • At least one parent self-identifies as foreign-born and first generation Hispanic immigrant, with one or more US-born 12-14 year old children.
  • Spanish speaking.
  • Provide written consent to participate in a parenting intervention trial.
  • Report financial challenges/restrictions.

Youth inclusion criteria:

  • 12-14 years old.
  • Self-identified as Hispanic or Latino.
  • English-, or Spanish-speaking, or bilingual.
  • Parent report at least one externalizing problem behavior.

Parent Exclusion Criteria:

  • Child Protective Services involvement due to confirmed child abuse or neglect
  • History of diagnosis with a severe psychiatric disorder.

Focal Youth exclusion criteria:

  • Hispanic validated version of Bird et al. screening test at 'high' level of problem behaviors.
  • Meets one or more of the DSM-IV-TR conduct or oppositional defiant or substance use disorders
  • Active case of documented sexual abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAPAS Youth Parenting Intervention
11-week CAPAS-Youth culturally adapted intervention
Behavioral: CAPAS-yOUTH
11-week parent training intervention exclusively delivered to parents
No Intervention: Wait-list control
Participants allocated to this condition receive the intervention until all assessments are completed for both arms in each cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Family Problem Solving: change in problem solving skills from baseline to 9 months
Time Frame: Change from baseline problem solving skills to 9 months
The originally titled scale, "family problem solving questionnaire" measures change in quality of problem solving parenting skills, such as the ability of parents to organize family meetings with youth to address family challenges (e.g., reaching consensus on how to best coordinate leisure time as a family). The measure utilizes a 5-point Likert-type scale with a minimum value =1 and maximum value =5. Higher scores mean better outcomes
Change from baseline problem solving skills to 9 months
Parenting Encouragement Skills: change in parenting encouragement skills from baseline to 9 months
Time Frame: Change from baseline parenting encouragement skills to 9 months
The originally titled scale, "Parenting encouragement skills" measures change in quality of parenting skills aimed at promoting adolescents' self-sufficient behaviors, such as the ability of youth to clean their room on a consistent basis. The measure utilizes a 5-point Likert-type scale with a minimum value =1 and maximum value =5. Higher scores mean better outcomes
Change from baseline parenting encouragement skills to 9 months
Parenting Positive Involvement Skills: change in parenting positive involvement skills from baseline to 9 months
Time Frame: Change from baseline parenting positive involvement skills to 9 months
The originally titled scale, "Parenting positive involvement skills" measures change in quality of parenting skills aimed at promoting a strong parent-youth emotional connection and overall parental positive involvement. The measure utilizes a 5-point Likert-type scale with a minimum value =1 and maximum value =5. Higher scores mean better outcomes
Change from baseline parenting positive involvement skills to 9 months
Parenting Discipline Skills: change in parenting discipline skills from baseline to 9 months
Time Frame: Change from baseline parenting discipline skills to 9 months
The originally titled scale, "Parenting discipline skills" measures change in quality of parenting skills aimed at implementing limit setting and discipline skills, such as removing privileges from youth when they do not follow family rules. The measure utilizes a 5-point Likert-type scale with a minimum value =1 and maximum value =5. Higher scores mean better outcomes
Change from baseline parenting discipline skills to 9 months
Parenting Monitoring and Supervision Skills: change in parenting monitoring and discipline skills from baseline to 9 months
Time Frame: Change from baseline monitoring and supervision skills to 9 months
The originally titled scale, "Parenting monitoring and discipline skills" measures change in quality of parenting skills aimed at implementing monitoring and supervision skills, such as tracking adolescents activities outside the home. The measure utilizes a 5-point Likert-type scale with a minimum value =1 and maximum value =5. Higher scores mean better outcomes
Change from baseline monitoring and supervision skills to 9 months
Adolescent Perceived Risk of Drug Use: change in youths' perceived risk of drug use from baseline to 9 months
Time Frame: Change from baseline adolescents perceived risk of drug use to 9 months
The originally titled scale, "Youth Perceived Harm of Drug Use" measures change in adolescents' perception of risk associate with a variety of drugs. The measure utilizes a 7-point Likert-type scale with a minimum value =1 and maximum value =7. Higher scores mean better outcomes
Change from baseline adolescents perceived risk of drug use to 9 months
Adolescent Drug Use: change in youths' drug use from baseline to 9 months
Time Frame: Change from baseline adolescent drug use to 9 months
The measure is an abbreviated measure of the originally titled scale, "Adolescent Drug Use," utilized in the Monitoring the Future study. The instrument measures frequency of use in the past 30 days on 5-point Likert-type scale with 0= indicating no use, and 1-5 indicating various frequencies of use for the past 30 days. Higher scores indicate worst outcomes (e.g., 5= I have used marijuana regularly in the past 30 days).
Change from baseline adolescent drug use to 9 months
Youth Problematic Behaviors - change in youths' problematic behaviors from baseline to 9 months
Time Frame: Change from baseline youth problematic behaviors to 9 months
The originally titled scale "Revised Behavioral Problem Checklist" measures adolescents' internalizing (e.g., sadness) and externalizing problematic behaviors (e.g., oppositional behaviors). The instrument measures parental perception of problematic behaviors on a 3-point Likert-type scale with 0 = not problematic behavior to 2 = serious problematic behavior. Thus, a higher score indicates a worse outcome
Change from baseline youth problematic behaviors to 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bicultural Involvement: change in parents and youth acculturation from baseline to 9 months
Time Frame: Change from baseline parents and youth acculturation to 9 months
The originally titled "bicultural involvement questionnaire" measures level of acculturation in parents and youth, as indicated by a variety of behaviors (e.g., my preferred language is English). The instrument measures level of acculturation on a 5-point Likert-type scale. Lower scores indicate a low US-oriented acculturation and higher scores indicate a high US-oriented acculturation
Change from baseline parents and youth acculturation to 9 months
Immigration-related Stress: change in parents' immigration related stress from baseline to 9 months
Time Frame: Change from baseline immigration-related stress to 9 months
The originally titled "Hispanic Stress Inventory" questionnaire measures immigration-related stress as experienced by parents (e.g., I have experienced discrimination because of my heritage). The instrument measures level of immigration-related stress on a 5-point Likert-type scale. Lower scores indicates lower levels of stress and higher scores indicate higher levels of immigration-relate stress
Change from baseline immigration-related stress to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose R Parra-Cardona, Ph.D., The University of Texas at Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019120075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only de-identified and aggregate data will be shared with other researchers per UT Austin IRB regulations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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