跳至主要内容
临床试验/NCT05407051
NCT05407051进行中(未招募)不适用

Investigating Effects of Family-Centered Treatment for Depression in Primary Care for Hispanic Youth

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
41
试验地点
2
主要终点
Change in Patient Health Questionnaire-9

研究概览

简要总结

Studies suggest that for youth in poverty, addressing stressors like parental mental health concerns may improve children's mental health outcomes. Rates of depression and suicidality are growing among teens nationwide and rates of depression are disproportionately high for Hispanic youth. Hispanic families are disproportionately impacted by poverty and are disproportionately exposed to adverse childhood experiences, yet Hispanic patients are less likely than non-Hispanic patient to have access to specialty mental healthcare. Integrating mental health care into primary care is one avenue towards making specialized mental healthcare more accessible to the Hispanic community. There have been few studies focused on addressing parental mental health within pediatric primary care, and even fewer focused specifically on supporting Hispanic families within primary care. The current study would seek to formally assess whether a family-centered treatment approach improves depression outcomes for both Hispanic teens and parents identified in primary care.

The current study would implement depression screening for teens and global mental health screening for parents in MetroHealth's Pediatric Hispanic Clinic. Teens identified with depression would receive integrated consultation with a psychology provider as usual. In this study, parents who agree to participate would also be screened for depression, anxiety, trauma and parenting stress. Parents who screen positive would then be randomized to receive either a list of referrals for bilingual mental health services in the community (treatment as usual), or into the family-centered treatment arm. In the family-centered treatment arm, parents would be connected directly to bilingual adult mental health services with a community partner, Catholic Charities, who would provide collateral therapy to parents via telehealth. Families will then receive follow-up calls from a bilingual MetroHealth provider 3- and 6-months later to re-administer the same parent outcome measures.

Investigators hypothesize that adolescent depression symptoms will improve to a greater degree in the family-centered treatment condition as compared to treatment as usual, and that measures of parental mental health and parenting stress will show significantly greater improvement in the family-centered treatment condition as compared to treatment as usual.

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
None

入排标准

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

入选标准

  • Teens 12+ seen in pediatric Hispanic clinic will be screened using the Patient Health Questionnaire -9 for depression as a part of standard clinic protocols. Parents of teens 12+ who screen positive for depression who also screen positive for mental health concerns may be included in the study. Parents who participate in the initial survey but who do NOT screen positive for any of their own mental health concerns will be given a list of mental health referrals and crisis numbers but will not be eligible to participate in the rest of the study or any follow-up calls.
  • Parents or legal guardians may be included in the study if their teen is over the age of 12, being seen in the pediatric Hispanic clinic, screens positive for depression during pediatric visit, and if parents then screen positive for any mental health concern during the initial survey.

排除标准

  • Adults unable to consent
  • Pregnant women
  • Prisoners

结局指标

主要结局

Change in Patient Health Questionnaire-9

时间窗: baseline, 3 and 6 month change

Measure of Depression - score ranges from 0-27 with higher scores indicating more symptoms of depression

Change in Generalized Anxiety Disorder-7

时间窗: baseline, 3 and 6 month change

Measure of Anxiety - score range from 0-21 with higher score indicating more symptoms of anxiety

次要结局

  • Change in Post Traumatic Stress Disorder CheckList - for Civilians(baseline, 3 and 6 month change)
  • Change in Parenting Stress Index -4(baseline, 3 and 6 month change)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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