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临床试验/NCT03407742
NCT03407742已完成不适用

Strengthening Hispanic Families Via NIDA Prevention Science

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
Revised Behavioral Problem checklist

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Data manager was in charge of conducting randomization and allocating parents to treatment conditions.

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Intervention

Experimental

CAPAS Youth Parenting Intervention

干预措施: CAPAS Youth (Behavioral)

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

结局指标

主要结局

Revised Behavioral Problem checklist

时间窗: Measured 4-5 months after T1 measurements

Measures youth's internalizing and externalizing problematic behaviors. Scale 0-2 with lower scores indicating worse outcomes.

Parenting Positive Involvement

时间窗: 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.

Parenting Skills Encouragement

时间窗: 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.

Parenting Discipline

时间窗: Measured 4-5 months after T1 measurements

Measures quality of parental limit setting skills. Scale 0-4 with lower score indicating worse outcome.

Parenting Supervision.

时间窗: 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.

Parenting Family Problem Solving

时间窗: 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.

Adolescents' Perceived Risk of Drug Use

时间窗: 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.

Adolescents' Likelihood of Drug Use.

时间窗: 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.

次要结局

  • Bicultural Involvement Questionnaire(Measured 4-5 months after T1 measurements)
  • Hispanic Stress Inventory(Measure 4-5 months after T1 measurements)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose R Parra-Cardona

Associate Professor

University of Texas at Austin

研究点 (1)

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