Strengthening Hispanic Families Via NIDA

January 22, 2018 updated by: Jose R Parra-Cardona, University of Texas at Austin

Strengthening Hispanic Families Via NIDA Prevention Science

The proposed specific aims of this K01 pilot study were:

  1. Develop a culturally adapted and web-enhanced version of the Parent Management Training-the Oregon model (GenerationPMTO) intervention for first generation Hispanic families with youth.
  2. Implement a small randomized controlled trial (RCT) with the culturally adapted and web-enhanced version of the GenerationPMTO intervention.
  3. Systematically examine the implementation feasibility (i.e., rates of engagement, retention, and cultural acceptability) and initial efficacy of the adapted intervention (i.e., reduced parental stress and depression, increased quality of parenting skills, reduced levels of internalizing and externalizing behaviors in youth, and reduced adolescent substance use likelihood).

Study Overview

Status

Status

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

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

Recruitment. Participants were recruited according to eligibility criteria, in close collaboration with community partners. Specifically, health and mental health care centers, as well as community organizations and churches were targeted for recruitment activities. Recruitment also consisted of snowball recruitment from participants exposed to the intervention.

General Description of the Intervention. The Parent Management Training-Oregon model (GenerationPMTO) intervention is delivered primarily to parents in order to strengthen parenting skills in a safe learning environment that empower parents to implement these skills at home. The development of the original GenerationPMTO Spanish manual was conducted by Dr. Domenech-Rodriguez according to a comprehensive model of cultural adaptation research.

The intervention consisted of GenerationPMTO and culturally-focused sessions. The GenerationPMTO-focused sessions are detailed in the core treatment manual and have been translated into Spanish utilizing a rigorous process of translation and consultation with Hispanic scholars. Culturally-focused sessions integrated content from three sources. First, we informed sessions according to relevant literature focused on biculturalism. We also informed the intervention by addressing specific cultural themes that were identified as salient in our qualitative studies, which correspond to existing literature on risk and protective factors associated with Hispanic youth. Finally, parents were invited to reflect on additional cultural values and experiences that they consider relevant to their parenting efforts.

With regard to content of individual sessions, module 1 addressed issues associated with immigration, Hispanic culture, and bicultural frameworks. Module 2 addressed issues associated with parenting and biculturalism. Modules 3-6 covered the GenerationPMTO core components as they apply to adolescent populations. Module 7 consists of an in-person session to refine and troubleshoot parenting skills that parents may consider particularly challenging. To enhance the cultural relevance of GenerationPMTO components, we will present all GenerationPMTO parenting skills according to bicultural frameworks, a strategy highly effective the R34 study.

Modules 8-9 reinforced issues of biculturalism having exposed parents to all PMTO core components. A strong focus on biculturalism is particularly relevant as empirical research has demonstrated that the promotion of biculturalism constitutes an effective protective factor for Hispanic youth in first generation Hispanic families.

Randomization. The individual family was the unit of computer-derived randomization, with PTMO-control balance sought for (a) gender of target youth, and (b) time of recruitment. Assessments. Data collection was completed after recruitment (T1) and upon intervention completion (T2).

Intervention Delivery. The intervention was delivered in a major faith-based organization as this site was the preferred site selected by Latino/a parents. In addition to the parenting intervention, a strong advocacy approach was implemented to address various needs of parents (e.g., referral to job training programs or immigration services).

Analyses. Tests of the primary hypothesis will involve fitting of the more assumption-laden subject-specific multivariate response model to Likelihood of Youth Substance Use (LYUS) sub-scale values, followed by fitting of the somewhat more conservative Generalized Estimating Equations (GEE) marginal model with the advantage of fewer assumptions.Our papers will report crude and covariate-adjusted efficacy estimates from both models, allowing readers to draw inferences based on either or both approaches. These same models are used to test the secondary efficacy hypotheses about program impact on parenting skill levels, youth internalizing/externalizing behaviors, and parent stress levels.

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 (Actual)

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.
168

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 Locations

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

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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/a immigrant, with one or more US-born 12-14 year old children in middle school.
  • Spanish speaking.
  • Provide written consent to participate in a parenting intervention trial.
  • Have access to phone service in home and have home-based internet access.
  • Report a combined annual family income is equal or lower than federal income guidelines for families eligible to receive federal welfare assistance.

Youth inclusion criteria:

  • Age 12-14 years old.
  • Attending middle school.
  • 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 any severe psychiatric disorder.

Focal Youth exclusion criteria:

  • Hispanic validated version of Bird et al. screening test at 'high' level of problem behaviors.
  • One or more of the DSM-IV-TR conduct or oppositional defiant or substance use disorders
  • 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: Single

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: Intervention
CAPAS Youth Parenting Intervention
Behavioral: CAPAS Youth
9-week parenting intervention
No Intervention: Wait-list control
Participants allocated to this condition were offered the parenting intervention until all T2 assessments of the intervention arm were completed

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
Parenting Positive Involvement
Time Frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices aimed at improving parent-youth relationship. Scale 0-4, with lower scores indicating worse outcome.
Measured 4-5 months after T1 measurements
Parenting Skills Encouragement
Time Frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices aimed at motivating children's self-sufficient behaviors. Scale 0-4 with lower scores indicating worse outcomes.
Measured 4-5 months after T1 measurements
Parenting Discipline
Time Frame: Measured 4-5 months after T1 measurements
Measures quality of parental limit setting skills. Scale 0-4 with lower score indicating worse outcome.
Measured 4-5 months after T1 measurements
Parenting Supervision.
Time Frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices focused on monitoring and supervision. Scale 0-4 with lower score indicating worse outcome.
Measured 4-5 months after T1 measurements
Parenting Family Problem Solving
Time Frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices aimed at helping youth develop problem solving skills. Scale 0-4 with lower score indicating worse outcome.
Measured 4-5 months after T1 measurements
Adolescents' Perceived Risk of Drug Use
Time Frame: Measured 4-5 months after T1 measurements
Measures changes in youth's perception of drug use. Scale 0-4 with higher score indicating best outcome.
Measured 4-5 months after T1 measurements
Adolescents' Likelihood of Drug Use.
Time Frame: Measured 4-5 months after T1 measurements
Measures likelihood of youth engaging in drug use. Scale 0-5 with higher score indicating best outcome. Scale 1-5 with higher score indicating worse outcome.
Measured 4-5 months after T1 measurements
Revised Behavioral Problem checklist
Time Frame: Measured 4-5 months after T1 measurements
Measures youth's internalizing and externalizing problematic behaviors. Scale 0-2 with lower scores indicating worse outcomes.
Measured 4-5 months after T1 measurements

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 Questionnaire
Time Frame: Measured 4-5 months after T1 measurements
Measures level of acculturation in parents and youth. Scale 1-5. Lower scores indicate US oriented identity and high score indicate Latino-oriented identity.
Measured 4-5 months after T1 measurements
Hispanic Stress Inventory
Time Frame: Measure 4-5 months after T1 measurements
Measurements parental stress characteristic of Hispanic immigrant populations. Score 0-5 with higher scores indicating worse outcome.
Measure 4-5 months after T1 measurements

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Michigan State University

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.
June 1, 2015

Primary Completion (Actual)

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.
August 1, 2017

Study Completion (Actual)

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.
December 1, 2017

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).
December 1, 2017

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.
January 16, 2018

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.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

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.
January 24, 2018

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.
January 22, 2018

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.
January 1, 2018

More Information

Terms related to this study

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.
  • 1K01DA036747 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

According to IRB regulations, no identifiable data will be shared, only aggregate data. However, the timing for sharing is not yet determined.

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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