NCT03407742

Brief Summary

The proposed specific aims of this K01 pilot study were:

  1. 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. 2.Implement a small randomized controlled trial (RCT) with the culturally adapted and web-enhanced version of the GenerationPMTO intervention.
  3. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

December 1, 2017

Last Update Submit

January 22, 2018

Conditions

Outcome Measures

Primary Outcomes (8)

  • Parenting Positive Involvement

    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

    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

    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.

    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

    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

    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.

    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

    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 Outcomes (2)

  • Bicultural Involvement Questionnaire

    Measured 4-5 months after T1 measurements

  • Hispanic Stress Inventory

    Measure 4-5 months after T1 measurements

Study Arms (2)

Intervention

EXPERIMENTAL

CAPAS Youth Parenting Intervention

Behavioral: CAPAS Youth

Wait-list control

NO INTERVENTION

Participants allocated to this condition were offered the parenting intervention until all T2 assessments of the intervention arm were completed

Interventions

CAPAS YouthBEHAVIORAL

9-week parenting intervention

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/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.
  • 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.

You may not qualify if:

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

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

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Data manager was in charge of conducting randomization and allocating parents to treatment conditions.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were randomized to one of two conditions: (a) intervention consisting of parenting program, or (b) wait-list control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2017

First Posted

January 23, 2018

Study Start

June 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations