NCT04972851

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

August 4, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

4.1 years

First QC Date

July 1, 2021

Last Update Submit

December 2, 2024

Conditions

Keywords

autismgoalsschool supportsdetermination

Outcome Measures

Primary Outcomes (1)

  • 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.

    throughout study completion, an average of 18 months

Secondary Outcomes (4)

  • School Implementation Climate Scale

    baseline,12 weeks, and 24 weeks

  • Self-Determination Inventory (SDI-SR)

    baseline, 12 weeks, and 24 weeks

  • Goal Attainment Scaling (GAS)

    baseline, 12 weeks, and 24 weeks

  • Social Network Survey

    baseline, 12 months, and 18 months

Study Arms (2)

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.

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.

Behavioral: Self-Determined Learning Model of Instruction (SDLMI)

Interventions

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

Implementation as Usual (IAU)UNITED

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • school staff serving adolescents with ASD or NDD
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UC Davis MIND Institute

Davis, California, 95817, United States

Location

University of Kansas

Lawrence, Kansas, 66045, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental DisordersAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Development and Psychology

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 22, 2021

Study Start

August 4, 2021

Primary Completion

August 31, 2025

Study Completion

December 1, 2025

Last Updated

December 4, 2024

Record last verified: 2024-12

Locations