Autism Spectrum DisorderSDLMINCT04972851
AIRB-4: Self-Determined Learning Model of Instruction
A study testing Self-Determined Learning Model of Instruction (SDLMI) in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Health Resources and Services Administration (HRSA) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Autism Spectrum Disorder, Neurodevelopmental Disorders
- What is being tested?
- Self-Determined Learning Model of Instruction (SDLMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Aug 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UC Davis MIND Institute
Davis, California, 95817
University of Kansas
Lawrence, Kansas, 66045
University of Washington
Seattle, Washington, 98195
About this study
Official title: Autism Intervention Research Network on Behavioral Health: Self-Determined Learning Model of Instruction
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.
Read the 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.
- Being tested
- Self-Determined Learning Model of Instruction (SDLMI)
- Keywords
- autism, goals, school supports, determination
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Determined Learning Model of Instruction (SDLMI)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| UNITED | Experimental | 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. Receives: Behavioral: Self-Determined Learning Model of Instruction (SDLMI) |
| Implementation as Usual (IAU) | Active comparator | The organizations will implement SDLMI as usual. The research team will be available to provide support on the SDLMI intervention as needed. Receives: Behavioral: Self-Determined Learning Model of Instruction (SDLMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: throughout study completion, an average of 18 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: baseline, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start4 Aug 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Resources and Services Administration (HRSA)
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972851
- Sponsor's protocol ID
- 20-002001
- Acronym
- SDLMI
- Status last verified
- Dec 2024
- First submitted
- 1 Jul 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35842614
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Intervention Research Network on Behavioral Health: Self-Determined Learning Model of Instruction
- ClinicalTrials.gov ID
- NCT04972851
- Acronym / sponsor ID
- SDLMI / 20-002001
- Keywords
- autism, goals, school supports, determination
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Health Resources and Services Administration (HRSA)US federal agency
- Collaborators
- University of California, Davis, University of Kansas, University of Washington, University of Pennsylvania, University of Rochester, Drexel University
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UNITED | Experimental | Behavioral: Self-Determined Learning Model of Instruction (SDLMI)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. |
| Implementation as Usual (IAU) | Active comparator | 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Implementation as Usual (IAU), UNITED |
Primary outcome
Stages of Implementation Completion (SIC)
Time frame: throughout study completion, an average of 18 months
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.
4 secondary outcomes
School Implementation Climate Scale
Time frame: baseline,12 weeks, and 24 weeks
Self-Determination Inventory (SDI-SR)
Time frame: baseline, 12 weeks, and 24 weeks
Goal Attainment Scaling (GAS)
Time frame: baseline, 12 weeks, and 24 weeks
Social Network Survey
Time frame: baseline, 12 months, and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 35842614Locke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Determined Learning Model of Instruction (SDLMI) in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Health Resources and Services Administration (HRSA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stages of Implementation Completion (SIC) (time frame: throughout study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.