A Randomized Intervention Trial to Increase Access to Reproductive Health Services among Adolescents and Young Adults with intellectual and Developmental Disabilities

一项旨在增加智力和发育障碍青少年和年轻人获得生殖健康服务机会的随机干预试验

• 批准号: 10598720
• 负责人: Heidi Elizabeth Jones
• 金额: $ 79.13万
• 依托单位: GRADUATE SCHOOL OF PUBLIC HEALTH AND HEALTH POLICY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-02 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10598720
• 关键词: 21 year old; Adolescence; Adolescent; Adolescent and Young Adult; Adult; Advocate; African American; Age; Asian; Behavior; Child; Childhood; Communicable Diseases; Communities; Complex; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Control Groups; Data; Developmental Delay Disorders; Developmental Disabilities; Education; Educational Curriculum; Educational Intervention; Eligibility Determination; Enrollment; Ensure; Female; Fertility; Gender; Gender Identity; HIV; Health; Health Status; Health education; Healthcare; Hispanic; Home visitation; Human Papilloma Virus Vaccination; Hygiene; Individual; Informed Consent; Intellectual functioning disability; Intention; Intervention; Intervention Trial; Interview; Knowledge; Latinx; Legal Guardians; Living Arrangement; Measures; Medicaid services; Medical; Menstruation; Monitor; New York; Participant; Persons; Phase; Physical Exercise; Population; Population Heterogeneity; Pregnancy; Preventive; Process; Program Evaluation; Provider; Randomized; Randomized, Controlled Trials; Reporting; Reproductive Health; Reproductive Health Services; Risk; Schools; Services; Sex Behavior; Sex Education; Sexual Health; Sexuality; Sexually Transmitted Diseases; Socialization; South Carolina; Testing; Treatment Efficacy; United States; Unwanted pregnancy; Update; Voice; Youth; academic standard; age group; aged; arm; community center; design; disability; effectiveness testing; efficacy testing; exercise intervention; experience; experimental group; health knowledge; improved; intersectionality; male; non-compliance; nutrition; open label; participant interview; peer; prevention practice; primary endpoint; primary outcome; programs; public health research; randomized trial; recruit; screening; secondary outcome; sex; sexual victimization; sexually active; social; success; translational study; young adult

Project Summary/Abstract We propose updating, piloting and testing a socialization and sex education curriculum (STEPS-2) designed for adolescents and young adults with intellectual and developmental disabilities (I/DD). We will test this updated curriculum in a randomized controlled trial (RCT) among 856 adolescents and young adults (aged 18- 27 years) with mild to moderate I/DD who receive services from disability providers in four of the five Developmental Disabilities Regions of the New York State Office for People with Developmental Disabilities. Randomization will be stratified by region, sex (male/female) and age (18-22, 23-27). Half of the participants will be randomized to receive the updated STEPS-2 socialization and sex education curriculum in individualized sessions during home visits, and the other half will receive a group-based intervention on physical exercise and nutrition in a local community center; only one roommate will be eligible to be enrolled from any group living arrangement to minimize spillover effects. Regional Coordinat ors will provide the 6-week long interventions, with interview data collected at baseline (prior to intervention), month 2 (completion of intervention), month 6 and month 12. We project completing recruitment into the RCT during the second quarter of year 3, and completion of month 12 assessments in the third quarter of year 4. The primary outcome will be proportion of participants reporting having had a conversation about sex/reproductive health with a medical provider by month 12, with secondary outcomes including HPV vaccination status, receipt of sex and age-specific preventive health screening, social sexual behaviors, agency over decisions, and, among those sexually active, use of contraception (if not desiring a pregnancy), and use of sexually transmitted infection/HIV protection. Interim measures will be used to assess knowledge and to reduce the likelihood of recall bias for the primary endpoint. Specifically, we aim to: (1) Update and pilot an existing socialization and sex education curriculum (STEPS-2) for 18-27 year olds with I/DD in New York State through a participatory process centering the voices of diverse lived experiences; (2) Test the efficacy of this socialization and sex education curriculum in a randomized intervention trial using intention-to-treat and instrumental variable analyses to adjust for compliance. We hypothesize that at least an additional 10% of the individuals in the experimental group will have had a reproductive health discussion with a medical provider by month 12 compared with the control group; and (3) Test whether the efficacy of the intervention differs by sex and age in stratified analyses. We have powered the study for sex-specific efficacy estimates and will explore whether efficacy differs by age. The findings from this translational study will inform practitioners, advocates, and self-advocates about best practices for reproductive and sexual health education for adolescents and young adults with I/DD as they transition to adulthood.

项目摘要/摘要 我们建议更新、试行和测试设计的社会化和性教育课程(步骤2) 为有智力和发育障碍的青少年和青壮年(I/DD)。我们将对此进行测试 在一项随机对照试验(RCT)中，对856名青少年和青壮年(18岁- 27年)患有轻中度I/DD的人，在五人中有四人接受了残疾提供者的服务 纽约州发展障碍人士办公室的发展障碍地区。 随机分组将按地区、性别(男性/女性)和年龄(18-22岁、23-27岁)分层。一半的参与者 将随机接受更新的步骤-2社会化和性教育课程 在家访期间进行个体化治疗，另一半将接受基于群体的干预 在当地社区中心进行体育锻炼和营养；只有一名室友有资格参加 来自任何群体生活安排，以最大限度地减少溢出效应。区域协调员将提供为期6周的 长期干预，访谈数据收集在基线(干预前)、第2个月(完成 干预)、6个月和12个月。我们计划在第二个月完成招募到RCT 第三季度，并于第四年第三季度完成12个月的评估。主要结果 将是报告曾与 12个月前提供医疗服务，次要结果包括HPV疫苗接种状况、接受性行为和 特定年龄的预防性健康筛查、社会性行为、机构决策，等等 性行为活跃、避孕措施的使用(如果不想怀孕)和性传播感染/艾滋病毒的使用率 保护。将使用临时措施来评估知识，并减少召回偏见的可能性 主端点。 具体来说，我们的目标是：(1)更新和试行现有的社会化和性教育课程(步骤2) 为纽约州18-27岁的I/DD患者通过以不同声音为中心的参与性过程 亲身体验；(2)以随机抽样的方式检验该社会化与性教育课程的有效性 干预试验使用意向治疗和工具变量分析来调整依从性。我们 假设在试验组中至少有10%的人已经有了 与对照组相比，在12个月前与医疗提供者讨论生殖健康；以及(3) 分层分析中检验干预效果是否因性别和年龄不同而不同。我们已经为 对性别特异性疗效的研究估计并将探索疗效是否因年龄而不同。由此得出的结论是 翻译研究将使从业者、倡导者和自我倡导者了解生殖的最佳实践 以及在青少年和患有I/DD的年轻人过渡到成年期时对他们进行性健康教育。