Adolescent BehaviorNCT05291481
Implementing a Church-based Parenting Intervention for Hispanics
A study testing CAPAS-yOUTH in people with Adolescent Behavior and Parenting, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Parenting
- What is being tested?
- CAPAS-yOUTH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2020to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Steve Hicks School of Social Work, the University of Texas at Austin
Austin, Texas, 78712
Jose R Parra-Cardona, Ph.D., 517-232-9215, rparra@austin.utexas.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Behavior, Parenting
- Being tested
- CAPAS-yOUTH
- Keywords
- Parent Training, Cultural Adaptation
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPAS-yOUTHBehavioural
11-week parent training intervention exclusively delivered to parents
| Study group | Role | What they receive |
|---|---|---|
| CAPAS Youth Parenting Intervention | Experimental | 11-week CAPAS-Youth culturally adapted intervention Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
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
Measured: Change from baseline parents and youth acculturation to 9 months
Immigration-related Stress: change in parents' immigration related stress from baseline 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
Measured: Change from baseline immigration-related stress to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start21 Apr 2020
- Primary completion28 Feb 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 327 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose R Parra-Cardona, University of Texas at Austin
- Investigators
- Jose R Parra-Cardona, Ph.D., Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291481
- Sponsor's protocol ID
- 2019120075
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified and aggregate data will be shared with other researchers per UT Austin IRB regulations
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Church-based Parenting Intervention to Promote NIDA Prevention Science Among Hispanics
- ClinicalTrials.gov ID
- NCT05291481
- Acronym / sponsor ID
- 2019120075
- Conditions
- Adolescent Behavior, Parenting
- Keywords
- Parent Training, Cultural Adaptation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAPAS Youth Parenting Intervention | Experimental | Behavioral: CAPAS-yOUTH11-week CAPAS-Youth culturally adapted intervention |
| Wait-list control | No intervention | –Participants allocated to this condition receive the intervention until all assessments are completed for both arms in each cohort |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CAPAS-yOUTH11-week parent training intervention exclusively delivered to parents | Behavioural | CAPAS Youth Parenting Intervention |
Primary outcome
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
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
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
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
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
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
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).
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No. Only de-identified and aggregate data will be shared with other researchers per UT Austin IRB regulations
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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.
Jose R Parra-Cardona, Ph.D. principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPAS-yOUTH in people with Adolescent Behavior and Parenting, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose R Parra-Cardona, Ph.D. (5174020935, rparra@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.