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
基本信息
- 批准号:10598720
- 负责人:
- 金额:$ 79.13万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:21 year oldAdolescenceAdolescentAdolescent and Young AdultAdultAdvocateAfrican AmericanAgeAsianBehaviorChildChildhoodCommunicable DiseasesCommunitiesComplexContraceptive AgentsContraceptive UsageContraceptive methodsControl GroupsDataDevelopmental Delay DisordersDevelopmental DisabilitiesEducationEducational CurriculumEducational InterventionEligibility DeterminationEnrollmentEnsureFemaleFertilityGenderGender IdentityHIVHealthHealth StatusHealth educationHealthcareHispanicHome visitationHuman Papilloma Virus VaccinationHygieneIndividualInformed ConsentIntellectual functioning disabilityIntentionInterventionIntervention TrialInterviewKnowledgeLatinxLegal GuardiansLiving ArrangementMeasuresMedicaid servicesMedicalMenstruationMonitorNew YorkParticipantPersonsPhasePhysical ExercisePopulationPopulation HeterogeneityPregnancyPreventiveProcessProgram EvaluationProviderRandomizedRandomized, Controlled TrialsReportingReproductive HealthReproductive Health ServicesRiskSchoolsServicesSex BehaviorSex EducationSexual HealthSexualitySexually Transmitted DiseasesSocializationSouth CarolinaTestingTreatment EfficacyUnited StatesUnwanted pregnancyUpdateVoiceYouthacademic standardage groupagedarmcommunity centerdesigndisabilityeffectiveness testingefficacy testingexercise interventionexperienceexperimental grouphealth knowledgeimprovedintersectionalitymalenon-compliancenutritionopen labelparticipant interviewpeerprevention practiceprimary endpointprimary outcomeprogramspublic health researchrandomized trialrecruitscreeningsecondary outcomesexsexual victimizationsexually activesocialsuccesstranslational studyyoung adult
项目摘要
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/文摘
项目成果
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