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AIRB-4: Self-Determined Learning Model of Instruction (SDLMI)

Primary Purpose

Autism Spectrum Disorder, Neurodevelopmental Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Determined Learning Model of Instruction (SDLMI)
Sponsored by
Health Resources and Services Administration (HRSA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, goals, school supports, determination

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • school staff serving adolescents with ASD or NDD
  • 63 adolescents ages 13-19 with ASD or NDD and family is under-resourced.
  • Expert medical diagnosis or educational classification of ASD

Under-resourced, defined by:

  • Attending a Title I school (a school that receives federal funding to improve the performance of economically disadvantaged students)or rural school
  • Family income is under 250% of the federal guidelines for poverty rate (i.e., meets federal requirements to qualify for free or reduced lunch)
  • Parent/Caregiver willing to participate

Exclusion Criteria:

  • Personnel at school not working with adolescents with ASD or NDD
  • Adolescents: under the age of 13 or over the age of 19, does not have ASD or NDD and family is not under-resourced.
  • No official ASD/NDD diagnosis.
  • Parent/Caregiver not willing to participate

Sites / Locations

  • UC Davis MIND Institute
  • University of KansasRecruiting
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UNITED

Implementation as Usual (IAU)

Arm Description

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.

The organizations will implement SDLMI as usual. The research team will be available to provide support on the SDLMI intervention as needed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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."
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.

Full Information

First Posted
July 1, 2021
Last Updated
February 27, 2023
Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT04972851
Brief Title
AIRB-4: Self-Determined Learning Model of Instruction
Acronym
SDLMI
Official Title
Autism Intervention Research Network on Behavioral Health: Self-Determined Learning Model of Instruction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Neurodevelopmental Disorders
Keywords
autism, goals, school supports, determination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
358 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UNITED
Arm Type
Experimental
Arm Description
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.
Arm Title
Implementation as Usual (IAU)
Arm Type
Active Comparator
Arm Description
The organizations will implement SDLMI as usual. The research team will be available to provide support on the SDLMI intervention as needed.
Intervention Type
Behavioral
Intervention Name(s)
Self-Determined Learning Model of Instruction (SDLMI)
Intervention Description
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
Primary Outcome Measure Information:
Title
Stages of Implementation Completion (SIC)
Description
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
Secondary Outcome Measure Information:
Title
School Implementation Climate Scale
Description
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
Title
Self-Determination Inventory (SDI-SR)
Description
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
Title
Goal Attainment Scaling (GAS)
Description
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
Title
Social Network Survey
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: school staff serving adolescents with ASD or NDD 63 adolescents ages 13-19 with ASD or NDD and family is under-resourced. Expert medical diagnosis or educational classification of ASD Under-resourced, defined by: Attending a Title I school (a school that receives federal funding to improve the performance of economically disadvantaged students)or rural school Family income is under 250% of the federal guidelines for poverty rate (i.e., meets federal requirements to qualify for free or reduced lunch) Parent/Caregiver willing to participate Exclusion Criteria: Personnel at school not working with adolescents with ASD or NDD Adolescents: under the age of 13 or over the age of 19, does not have ASD or NDD and family is not under-resourced. No official ASD/NDD diagnosis. Parent/Caregiver not willing to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Kasari, PhD
Phone
310-825-8342
Email
kasari@gseis.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Consuelo Garcia, BS
Phone
310-825-4775
Email
cogarcia@mednet.ucla.edu
Facility Information:
Facility Name
UC Davis MIND Institute
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Fitzgerald, MA
Email
afitzgerald@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Aubyn Stahmer, PhD
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lashanna Brunson
Email
lbrunson@ku.edu
First Name & Middle Initial & Last Name & Degree
Brian Boyd, PhD
First Name & Middle Initial & Last Name & Degree
Karrie Shogren, PhD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Locke, PhD
Phone
216-616-6703
Email
jjlocke@uw.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
35842614
Citation
Locke J, Hassrick EM, Stahmer AC, Iadarola S, Boyd B, Mandell DS, Shih W, Hund L, Kasari C; AIR-B Network. Using Novel Implementation Tools for Evidence-based Intervention Delivery (UNITED) across public service systems for three evidence-based autism interventions in under-resourced communities: study protocol. BMC Psychiatry. 2022 Jul 16;22(1):478. doi: 10.1186/s12888-022-04105-9.
Results Reference
derived

Learn more about this trial

AIRB-4: Self-Determined Learning Model of Instruction

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