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临床试验/NCT03028792
NCT03028792已完成不适用

Attention Training for Underserved Youth With Anxiety

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Change in Clinical Global Impression-Severity (CGI-S) and Improvement, (CGI-I) Scales, Pre- to Post-Treatment

研究概览

简要总结

This study aims to test the efficacy and feasibility of administering a computerized attention training program targeting clinical levels of anxiety in Latino youth between the ages of 8-17. 52 youth from Imperial County, a rural and predominantly Latino region, will be randomized to receive either 1) a 12-session attention modification program (AMP) or 2) an attention condition program (non-active treatment). Clinical assessment of symptom severity will be conducted before, during, and after treatment. We hypothesize that at the end of treatment, children who receive the active intervention (AMP) will show (1) decreased attention bias to anxiety-related triggers using an independent measure of attention bias to assess change and (b) reduced anxiety severity. We also hypothesize that this study will be feasible, tolerable, acceptable, and safe in this underserved sample of Latino youth. This study is an initial step towards demonstrating the feasibility of implementing a novel computerized attention training program in anxiety in underserved community samples.

详细描述

The main aim of this pilot study is to examine the feasibility, tolerability, and acceptability of a computerized attention training program for children who have clinically elevated anxiety. Youth from a rural Latino community, with significant anxiety symptoms (N = 52) will be randomized to an active attention bias modification program (AMP) for four weeks or to an attention control condition (nonactive) for four weeks. Families will be assessed at baseline, mistreatment, post-treatment and 3 month followup. AMP responders will be determined by reduction on a self-report measure of anxiety and a clinician administered assessment. Community health workers (promotoras) will be trained to administer the program to youth. Data will be gathered to examine the feasibility, tolerability, and acceptability of this type of treatment and this mode of service delivery. It is hypothesized that the AMP will be feasible, tolerable, and acceptable to this underserved community sample of ethnic minority youth.

Study Design: Following ascertainment of study eligibility and completion of baseline assessment, youth will be assigned to four weeks of AMP or ACC (attention control condition). All youngsters and their families will undergo a comprehensive baseline assessment and be reassessed at mistreatment, treatment endpoint (week 4) and 3 month followup.

Screening: Youth will be recruited through various mechanisms.

  1. Flyers will be posted in primary care clinics in Imperial Valley and Los Angeles County. Clinicas de Salud del Pueblo is a private, non-profit corporation providing primary care services throughout Imperial County. Flyers will be posted in the 10 primary care clinics, located in Imperial County.
  2. The second method for recruiting subjects will be through physician referral from providers within the primary care systems. Prior to the study start, all pediatricians/providers will receive information about the study, symptoms of child anxiety, and the use of a short screening measure to assist in detecting child anxiety. If a provider at one of the clinics identifies a child with anxiety or a parent reports that child has symptoms consistent with anxiety (fears, worries, nervousness, unexplained somatic complaints, etc.), the provider will have the option to explain the study to the parent and give them the study brochures. Alternatively, providers, if able, can also ask parents to sign a consent to contact form, giving the research team permission to contact them directly to discuss the study.
  3. Providers may also chose to refer the patient to the study promotora who will assist will explaining the study to the participant, screening, and consenting the participants.
  4. Flyers will also be posted at Sun Valley Behavioral Medical Center, a private medical clinic that serves the medical and mental health needs of children, adolescents and adults in Imperial County. In this case, parents will be expected to call our research team for more information.
  5. The co-PI on this study, Dr. Denise Chavira has an ongoing school based study being conducted with high school students in Imperial Valley. Given that this study covers a range of ages (8-17), we will also recruit from high schools. As part of the existing consent form (for protocol 14-000663), students are asked to check the box if they are interested in participating in future research studies. We will contact those students who have indicated interest in future studies to discuss the current project.

In all of these methods, the community health worker/promotora/e will contact the parent to conduct an initial screen. Thereafter the promotora and/or research coordinator will arrange an in person meeting with the parent and youth to review the consent with the parent and assent form with the youth and administer the eligibility measures. The initial eligibility assessments will not be conducted until all consent/assent forms have been signed and returned to the research team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children and parents of children ages 8 through 17 inclusive at the time of initial evaluation
  • Clinically significant levels of anxiety as measured by self-report
  • Unmedicated or on stable medication treatment for at least 6 weeks prior to study entry, with no planned changes for duration of study participation.
  • Child is fluent English or Spanish speaker, given that all of our assessments as well as the language-based treatment protocol have thus far only been validated in English and Spanish.
  • Parental Informed Consent and Child Informed Assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
  • Child self-identifies as Latino/Hispanic

排除标准

  • Excessive or Problematic Substance Use as reported per initial telephone screening, or significant disruptive behavior problems within the past 3 months.
  • Indication of clinically significant suicidality, mania, or psychotic disorder.
  • Any serious psychiatric, psychosocial, or neurological condition (i.e., ADHD, tourettes, anxiety, severe aggression) requiring immediate treatment.

结局指标

主要结局

Change in Clinical Global Impression-Severity (CGI-S) and Improvement, (CGI-I) Scales, Pre- to Post-Treatment

时间窗: through study completion, average of 4 weeks

Participants receiving a post-treatment CGI-I score of 1 (very much improved) or 2 (much improved) on this one-item, 7-point rating will be considered treatment responders.

次要结局

  • Change in Attention Network Task Pre- to Post-Treatment(through study completion, average of 4 weeks)
  • Change in Visual search task Pre to Post-Treatment(through study completion, average of 4 weeks)
  • Change in Pediatric Anxiety Rating Scale Pre to Post-treatment(through study completion, average of 4 weeks)
  • Change in Screen for Child Anxiety Related Emotional Disorders (SCARED) Pre- to Post-Treatment(through study completion, average of 4 weeks)

研究者

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

Susanna Chang, PhD

Principal Investigator

University of California, Los Angeles

研究点 (2)

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