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.

项目总结/摘要 我们建议更新、试行和测试社会化和性教育课程（STEPS-2）， 为智力和发育障碍（I/DD）的青少年和年轻人提供。我们将测试这个 在856名青少年和年轻成人（18 - 19岁）中进行的随机对照试验（RCT）中， 27岁）的轻度至中度I/DD，在五分之四的患者中接受残疾提供者的服务。 纽约州发育障碍人士办公室的发育障碍地区。 随机化将按地区、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STEPS-2社会化和性教育课程， 在家访期间进行个性化的课程，另一半将接受基于小组的干预， 体育锻炼和营养在当地社区中心;只有一个室友将有资格参加 避免任何集体生活安排，以尽量减少溢出效应。区域协调员将提供为期6周的 长期干预，在基线（干预前）、第2个月（完成 干预），6个月和12个月。我们计划在第二年完成RCT的招募工作， 第三年第三季度完成第12个月的评估。主要结局 将是参与者中报告曾与一名妇女就性/生殖健康问题进行过对话的比例， 第12个月的医疗提供者，次要结局包括HPV疫苗接种状态、性生活接受情况和 特定年龄的预防性健康检查，社会性行为，决策机构，其中， 性活跃、使用避孕措施（如果不希望怀孕）和使用性传播感染/艾滋病毒 保护临时措施将用于评估知识，并减少回忆偏倚的可能性， 即主要终点。 具体而言，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） 通过一个参与性的过程，集中不同的声音，在纽约州的18 - 27岁的I/DD 生活经验;（2）在一个随机的社会化和性教育课程的有效性测试 使用意向治疗和工具变量分析进行干预试验，以调整依从性。我们 假设实验组中至少有另外10%的人会有一个 与对照组相比，第12个月与医疗提供者进行生殖健康讨论;（3） 在分层分析中检验干预的有效性是否因性别和年龄而异。我们已经为 研究性别特异性疗效估计，并将探讨疗效是否因年龄而异。这一发现 翻译研究将告知从业者，倡导者和自我倡导者关于生殖健康的最佳做法。 和性健康教育的青少年和年轻的成年人与I/DD，因为他们过渡到成年。