An interventional study of Self-Determined Learning Model of Instruction (SDLMI) in Autism Spectrum Disorder and Neurodevelopmental Disorders, sponsored by Health Resources and Services Administration (HRSA). Active, not recruiting at 3 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Health Resources and Services Administration (HRSA) · Not applicable, Interventional, and Treatment
The AIRB research team will compare the use and effectiveness of each intervention (Mind the Gap, Remaking Recess and Self Determined Learning Model of Instruction) with and without the addition of our implementation strategy, UNITED. In all groups, the research team will train community practitioners using remote delivery of professional development modules specific to the intervention and active coaching as dictated by the intervention procedures.
The research team will pair UNITED with three interventions that cover the ages of early childhood, childhood, and adolescence. These include Mind the Gap (MTG), a family navigation intervention for children newly diagnosed under age 8, Remaking Recess (RR), a school-based social/peer engagement intervention for children ages 5-12, and Self-Determination Learning Model of Instruction (SDMLI), a self-advocacy intervention for adolescents (13-22 years; 22 is the upper age limit of high school for individuals with disabilities).
For the SDLMI, school personnel will be trained to work with adolescents with ASD using the SDLMI model. This model will help students with ASD set their own goals and help attain them. The total time commitment for the school personnel is 1 school year (2 semesters) for about 47 hours. The total time commitment for the parent of the student with ASD is about 1 hour (sign consent/fill out demographic survey). The total time commitment for the student with ASD is 1 school year (2 semesters) for about 25.25 hours.
SDLMI targets school-based providers across grade levels (i.e., 6th - 12th grade) and disciplines (e.g., special education, general education). They will receive 7.5 hours of remote professional development in SDLMI. Coaching will take placed based on the SDLMI Facilitator Objectives that provide a road map for the facilitator. In school contexts, SDLMI instruction is implemented over the course of a school year or 2 semesters (approximately 24 weeks). Practitioners will receive 12 hours of remote coaching during sessions with students.
There will be 3 assessment time points. At entry, the teachers/school staff will fill out Demographic, Implementation Climate, Knowledge, Skills, and Use, and Acceptability of Intervention Measure (AIM). At 12 weeks of the study and at 24 weeks of the study (exit), they will fill out Implementation Climate, Knowledge, Skills, and Use, and Acceptability of Intervention Measure (AIM). Teachers/school staff will also fill out SDLMI fidelity questionnaire 6 times over the course of the school year. The parents will fill out a Demographic form at entry. Students will complete the following questionnaires at entry, mid-study (12 weeks) and end of study (24 weeks): the Self Determination Inventory: Student Report and Goal Attainment Scaling as a part of the SDLMI intervention.
All participants in SDLMI will be randomized to receive UNITED, exploratory implementation strategy, or implementation as usual (IAU). UNITED is premised on the idea that successful implementation in organizations like schools and early intervention systems requires a team-based approach, in which the team is thoughtfully assembled, develops a plan for implementation, assigns roles and responsibilities, and carefully tracks and supports implementation and sustainment in all its stages. To address these requirements, the research team combined two well-tested strategies. The first is social network analysis (SNA) through which the research team will systematically identify members of the team who will implement each intervention. The second is TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety), an evidence-based set of teamwork tools that optimizes target population outcomes by improving communication and teamwork skills. The research staff will approach the school leaders (2 at maximum) and explain SDLMI. After the school leaders agree to participate in the study, they will complete a site agreement to participate and then fill out the Social Network Assessment (SNA) to provide names, roles, and emails of school personnel at the school that have significant roles in the school that relate to SDLMI. The research staff will then email these school personnel the SNA as well. After receiving the completed SNA assessments, the research staff will randomize each organization to UNITED vs Implementation as Usual (IAU). The research team will use the data from these assessments to assess both arms of the study. Additionally, for those randomized to UNITED, Dr. Elizabeth McGhee Hassrick at Drexel University and her team, will provide the research sites the top 2-5 school personnel identified by the SNA as key for intervention implementation support. This team will be invited to participate in the UNITED implementation team.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 358 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Health Resources and Services Administration (HRSA) is the lead sponsor of 8 studies on the registry; none are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Under-resourced, defined by:
Exclusion Criteria:
UNITED is premised on the idea that successful implementation in organizations like schools and early intervention systems requires a team-based approach, in which the team is thoughtfully assembled, develops a plan for implementation, assigns roles and responsibilities, and carefully tracks and supports implementation and sustainment in all its stages within a few meetings and ongoing coaching from the research staff.
Behavioral: Self-Determined Learning Model of Instruction (SDLMI)
The organizations will implement SDLMI as usual. The research team will be available to provide support on the SDLMI intervention as needed.
Behavioral: Self-Determined Learning Model of Instruction (SDLMI)
SDLMI is a teaching model that enables providers to teach students to: * make choices and decisions about setting a goal * develop action plans for academic or other goals * self-monitor and self-evaluate progress toward goal attainment * adjust the goal or plan
Stages of Implementation Completion (SIC)
Tool developed by the Oregon Social Learning Center, is an 8 stage tool of implementation process and milestones, with stages spanning three implementation phases (pre-implementation, implementation, and sustainability.
Time frame: throughout study completion, an average of 18 months
School Implementation Climate Scale
This scale was adapted to be used by the research team to gather information from the schools/agencies in the study about the use of evidence-based practices in their organizations. It is rated from 0 to 4, with 0 being "not at all" and 4 being "very great extent." The higher the rating, the better the outcome.
Time frame: baseline,12 weeks, and 24 weeks
Self-Determination Inventory (SDI-SR)
The Self-Determination Inventory (SDI) is comprised of a validated measure of self-determination created by researchers Karrie A. Shogren and Michael L. Wehmeyer at the University of Kansas. he SDI asks people to rate how they feel about their ability to be self-determined; that is to make choices, set and go after goals, and make decisions.
Time frame: baseline, 12 weeks, and 24 weeks
Goal Attainment Scaling (GAS)
The GAS is used to measure progress toward meeting goals. The goal is rated "much less than expected," "somewhat less than expected," "expected level of outcome," "somewhat more than expected," and "much more than expected." There is no numerical scaling, but a better outcome is expected from "much less" to "much more."
Time frame: baseline, 12 weeks, and 24 weeks
Social Network Survey
Survey created by the research team to gather information about the key people in each organization that can better support the SDLMI intervention.
Time frame: baseline, 12 months, and 18 months
Started Aug 2021 (actual). Primary completion is estimated for Aug 2025, 48 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 48 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Health Resources and Services Administration (HRSA)