NCT04199533

Brief Summary

This study proposes to redesign the RUBI Parent Training program, a low-intensity intervention for youth with autism spectrum disorder and disruptive behavior, for use by school personnel in the classroom. Using a mixed-methods approach, 40 school staff members from 20 elementary schools will be recruited to inform current classroom behavior management practices and RUBI redesign needs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

May 20, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

October 9, 2019

Last Update Submit

May 18, 2022

Conditions

Autism Spectrum DisorderDisruptive Behavior

Outcome Measures

Primary Outcomes (6)

  • Acceptability of Intervention Measure (AIM): 5-point scale

    The 4-item AIM assesses participants' acceptability of RUBI(ES). Raters score items on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree". Internal consistency (α = .89) and test-retest reliability were good (α = .83).

    Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)

  • Acceptability of Intervention Measure (AIM): 5-point scale

    The 4-item AIM assesses participants' acceptability of RUBI(ES). Raters score items on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree". Internal consistency (α = .89) and test-retest reliability were good (α = .83).

    Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)

  • Intervention Appropriateness Measure (IAM): 5-point scale

    The 4-item IAM assesses the appropriateness of RUBI(ES). Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree". Internal consistency (α = .87) and test-retest reliability were good (α = .87).

    Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)

  • Intervention Appropriateness Measure (IAM): 5-point scale

    The 4-item IAM assesses the appropriateness of RUBI(ES). Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree". Internal consistency (α = .87) and test-retest reliability were good (α = .87).

    Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)

  • Feasibility of Intervention Measure (FIM): 5-point scale

    The 4-item FIM assesses the feasibility of RUBI(ES). Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree". Internal consistency (α = .89) and test-retest reliability were good (α = .88).

    Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)

  • Feasibility of Intervention Measure (FIM): 5-point scale

    The 4-item FIM assesses the feasibility of RUBI(ES). Raters score each item on a 5-point scale ranging from (1) "Completely Disagree" to (5) "Completely Agree". Internal consistency (α = .89) and test-retest reliability were good (α = .88).

    Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)

Secondary Outcomes (2)

  • Intervention Usability Scale (IUS)

    Completed by participants during the 4-hour RUBI Redesign meeting (Aim 1)

  • Intervention Usability Scale (IUS)

    Completed by participants during the 4-hour RUBIES Redesign meeting (Aim 3)

Other Outcomes (2)

  • Teacher Demographics

    Completed by participants at the in-class behavior observation, 4-hour RUBI Redesign meeting, 2 hour RUBIES Collaborative design meeting, or 4 hour RUBIES Redesign meeting

  • School Demographics

    Collected over the course of the 12 month study through public record review of schools where participants are employed

Study Arms (4)

Classroom Observation

The investigators will use day-long observational and interview procedures with eight staff from four schools. The classroom observation will focus on documenting episodes of classroom disruptive behavior, including antecedents and consequences to the behaviors. The interview will involve discussing with staff decision-making processes and current needs around classroom behavioral management.

RUBI Redesign

Two separate demonstration studies comprising 6 staff members each will focus on informing adaptation or pruning needs related to RUBI content and structure to ensure the redesigned curriculum (RUBIES) is contextually appropriate for schools.

Behavioral: RUBI

RUBIES Collaborative Design

Eight staff from 4 schools will attend one of four 2-hour in-person feedback sessions to support collaborative feedback around RUBI redesign, including feasibility and appropriateness and methods supporting implementation.

Behavioral: RUBIES

RUBIES Redesign

Two separate demonstration studies comprising 6 staff members each will focus on informing final RUBIES adaptation or pruning needs.

Behavioral: RUBIES

Interventions

RUBIBEHAVIORAL

Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis

RUBI Redesign
RUBIESBEHAVIORAL

School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis

RUBIES Collaborative DesignRUBIES Redesign

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elementary school personnel who work with students with autism spectrum disorder

You may qualify if:

  • Elementary school (kindergarten through 5th grade) personnel (i.e. general and special education teachers, school psychologist, paraprofessionals)
  • Works with at least one student with ASD for part of the day

You may not qualify if:

  • School personnel who do not have contact with youth with ASD during the work day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Public Schools

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderProblem Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Study Officials

  • Karen Bearss, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor- Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

October 9, 2019

First Posted

December 16, 2019

Study Start

September 1, 2019

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

May 20, 2022

Record last verified: 2022-05

Locations

US(1)