Clinical trial NCT04972851: AIRB-4: Self-Determined Learning Model of Instruction
Official title: Autism Intervention Research Network on Behavioral Health: Self-Determined Learning Model of Instruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Neurodevelopmental Disorders
Keywords: autism
goals
school supports
determination
Lead sponsor: Health Resources and Services Administration (HRSA)
Sponsor class: FED
Collaborators: name: University of California, Davis
name: University of Kansas
name: University of Washington
name: University of Pennsylvania
name: University of Rochester
name: Drexel University
First posted: 2021-07-22
Enrollment: 358
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stages of Implementation Completion (SIC)
timeFrame: throughout study completion, an average of 18 months
Secondary outcomes:
measure: School Implementation Climate Scale
timeFrame: baseline,12 weeks, and 24 weeks
measure: Self-Determination Inventory (SDI-SR)
timeFrame: baseline, 12 weeks, and 24 weeks
measure: Goal Attainment Scaling (GAS)
timeFrame: baseline, 12 weeks, and 24 weeks
measure: Social Network Survey
timeFrame: baseline, 12 months, and 18 months
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis MIND Institute
state: California
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
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.