跳至主要内容
临床试验/NCT05928182
NCT05928182已完成不适用

El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham

Duke University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年10月10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
发起方
入组人数
32
试验地点
1
主要终点
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Parenting Sense of Competence Scale (PSOC)

研究概览

简要总结

Study team members from El Futuro in Durham, North Carolina have created an intervention called El Faro. El Faro helps Latinx families of children with ADHD understand and cope with the stress and difficulties presented by the disorder. We propose to develop a community-engaged research partnership between El Futuro and the Duke ADHD Program that aims to pilot-test an adapted El Faro treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Child is between the ages of 6 to 12 years
  • •Child has received a previous diagnosis of ADHD in the community based on caregiver report
  • •ADHD Rating Scale (parent rating scale of ADHD symptoms) symptom severity score of 24 or higher
  • •Child meets DSM-5 criteria for ADHD (any presentation) based on the MINI
  • •Generally healthy (i.e., no major medical problems that will interfere with study participation)
  • •Caregiver's willingness to keep any current psychiatric medication regimen for child diagnosed with ADHD constant throughout the study duration
  • •Caregiver age 18 years and older
  • •Caregiver self-identify as Latinx

排除标准

  • •Caregiver's child has previous diagnosis of Autism, Schizophrenia, or Bipolar Disorder in the community per caregiver report or other psychiatric disorder that is primary to ADHD or may interfere with study involvement.
  • •Caregiver unable to attend all El Faro sessions
  • •Plan to initiate new ADHD treatment for identified child with ADHD during study participation (previously established ADHD treatments are allowable)
  • •Other concerns besides ADHD that would interfere with study participation according to the study team.

研究组 & 干预措施

Treatment Participants

Experimental

Active treatment group participants

干预措施: El Faro Treatment Intervention (Behavioral)

结局指标

主要结局

Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Parenting Sense of Competence Scale (PSOC)

时间窗: (8 weeks)

A 16-item questionnaire with a 6-point Likert scale ranging from Strongly Disagree (1) - Strongly Agree (6). A total score range of 16 - 96. A higher score indicates a better outcome.

Feasibility of adapted El Faro Treatment as measured by homework compliance

时间窗: 8 weeks

Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Functional Impairment Scale (ADHD-FX)

时间窗: (8 weeks)

A 32-item questionnaire with 4-point Likert scale ranging from Not at All (0) - A lot (3). With a total score range of 0 - 96. A lower score indicates better outcome.

Acceptability of adapted El Faro Treatment as measured by how satisfactory participants felt that the treatment was overall

时间窗: 8 weeks

Acceptability will be based on how satisfactory participants felt that the treatment was overall (ranging from 1-7 with 7 indicating the highest rating of treatment satisfaction)

Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Rating Scale (ADHD-RS)

时间窗: (8 weeks)

An 18-item questionnaire with a 4-point Likert scale ranging from Never or Rarely (0) - Very Often (3). With a total score range of 0 -54. A lower score indicated a better outcome.

Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Scale of the Child Behavior Checklist (CBCL)

时间窗: (8 weeks)

A 7-item parent report questionnaire with a 3-point Likert Scale ranging from Not True (0) to Very True or Often True (2). A total score range of 0-14. Lower scores indicate a better outcome.

Feasibility of adapted El Faro Treatment as measured by percentage of attrition

时间窗: (8 weeks)

Attrition of \<25% will be set to establish feasibility

Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Attention Problem Scale of the Child Behavior Checklist (CBCL)

时间窗: (8 weeks)

A 10-item parent report questionnaire with a 3-point Likert Scale ranging from Not True (0) to Very True or Often True (2). A total score range of 0-20. Lower scores indicate better outcomes.

Acceptability of adapted El Faro Treatment as measured by caregiver perceptions

时间窗: 8 weeks

Caregiver perceptions about the extent of ADHD psychoeducation they received, how the content was relevant to their experiences, whether the techniques introduced were understandable, if they were confident about regularly using the techniques taught, and if they would recommend El Faro to other families of children with ADHD (on a scale ranging from 1 = not at all to 4 = extremely).

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

El Faro: Addressing Mental Health Inequities Among... | 临床试验