NCT05291481

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
327

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3.9 years

First QC Date

February 15, 2022

Last Update Submit

June 14, 2023

Conditions

Keywords

Parent TrainingCultural Adaptation

Outcome Measures

Primary Outcomes (8)

  • Family Problem Solving: change in problem solving skills from baseline 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

    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

    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

    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

    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

    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

    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

    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 Outcomes (2)

  • Bicultural Involvement: change in parents and youth acculturation from baseline to 9 months

    Change from baseline parents and youth acculturation to 9 months

  • Immigration-related Stress: change in parents' immigration related stress from baseline to 9 months

    Change from baseline immigration-related stress to 9 months

Study Arms (2)

CAPAS Youth Parenting Intervention

EXPERIMENTAL

11-week CAPAS-Youth culturally adapted intervention

Behavioral: CAPAS-yOUTH

Wait-list control

NO INTERVENTION

Participants allocated to this condition receive the intervention until all assessments are completed for both arms in each cohort

Interventions

CAPAS-yOUTHBEHAVIORAL

11-week parent training intervention exclusively delivered to parents

CAPAS Youth Parenting Intervention

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steve Hicks School of Social Work, the University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jose R Parra-Cardona, Ph.D.

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose R Parra-Cardona, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There is no masking in this study as participants are informed of the condition to which they are allocated
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: CAPAS-Youth is a culturally adapted version of the evidence-based intervention known as GenerationPMTO, which was originally adapted with a majority of Euro-American populations. The initial efficacy of CAPAS-Youth has already been demonstrated in a previous study. The current investigation is focused on tailoring CAPAS-Youth for Hispanic immigrants in Texas.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 22, 2022

Study Start

April 21, 2020

Primary Completion

February 28, 2024

Study Completion

July 30, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

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

Locations