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.

项目概要/摘要 我们建议更新、试点和测试设计的社会化和性教育课程（STEPS-2） 针对有智力和发育障碍（I/DD）的青少年和年轻人。我们将测试这个 一项针对 856 名青少年和年轻人（18 岁至 18 岁）的随机对照试验 (RCT) 更新了课程 27 岁）患有轻度至中度 I/DD，在五项中的四项中接受残疾服务提供者的服务 纽约州发育障碍人士办公室的发育障碍地区。 随机分组将按地区、性别（男/女）和年龄（18-22、23-27）进行分层。一半参加者 将被随机分配接受更新的 STEPS-2 社会化和性教育课程 家访期间进行个性化会议，另一半将接受基于小组的干预 当地社区中心的体育锻炼和营养；只有一名室友有资格报名 远离任何集体生活安排，以尽量减少溢出效应。区域协调员将提供为期 6 周的培训 长期干预，在基线（干预前）、第 2 个月（完成 干预），第 6 个月和第 12 个月。我们预计在第二个月期间完成 RCT 的招募 第 3 年的季度，并在第 4 年的第三季度完成第 12 个月的评估。 主要成果 报告曾与某个人就性/生殖健康进行过对话的参与者比例 12 个月前的医疗提供者，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、决策代理等 性活跃、使用避孕措施（如果不想怀孕）以及使用性传播感染/艾滋病毒 保护。将使用临时措施来评估知识并减少回忆偏差的可能性 主要终点。 具体来说，我们的目标是：（1）更新和试点现有的社会化和性教育课程（STEPS-2） 通过以不同群体的声音为中心的参与过程，为纽约州 18-27 岁的 I/DD 青少年提供帮助 生活经历； (2) 随机测试社会化和性教育课程的效果 使用意向治疗和工具变量分析来调整依从性的干预试验。我们 假设实验组中至少有另外 10% 的人有过 与对照组相比，第 12 个月时与医疗服务提供者进行生殖健康讨论；和（3） 在分层分析中测试干预效果是否因性别和年龄而异。我们已经为 研究针对特定性别的功效估计，并将探讨功效是否因年龄而异。由此得出的结论 转化研究将为从业者、倡导者和自我倡导者提供有关生殖的最佳实践的信息 对患有 I/DD 的青少年和年轻人向成年过渡时进行性健康教育。