NCT05742464

Brief Summary

This project is focused on evaluating outcomes related to this statewide clinical training effort in the RUBI parent training program. Up to 400 providers in Maine are enrolling in a "Level 1" 16-hour RUBI introductory training through one of three modalities (1) self-paced "On Demand" webinars, (2) 16 weekly one-hour meetings ("ECHO group"); or (3) "2-day live virtual trainings." Up to 140 providers who complete Level 1 are then being offered the option to advance to "Level 2" RUBI Certification Training. These varying clinical training options create the opportunity to study three groups of RUBI Training participants who received varying intensities/doses of training: (1) those who completed only the 16-hr psychoeducational training either live or On Demand, (2) those who complete only the 16-hr training via the hybrid consultation/training ECHO model, and (3) those who complete intensive fidelity consultation training in addition to the 16-hr introductory training. In order to examine the impact of training dosage and modality on outcomes of this RUBI clinical training effort, we are conducting two related studies: The purpose of Study 1 is to learn about the crucial elements of RUBI intervention training in relation to promoting community provider implementation success. This will be measured by providers' self-reported data related to: 1) satisfaction with the RUBI training, 2) knowledge gained about behavioral principles through the training, 3) improvements in self-efficacy in supporting autistic youth with challenging behaviors and their caregivers, and 4) satisfaction with the RUBI intervention, including strategies used in practice with caregivers of youth with ASD/IDD. In other words, what is a "good enough" dose of RUBI training to promote provider satisfaction with the training, intervention, and use of RUBI strategies? The purpose of Study 2 is to provide an examination of RUBI intervention implementation by examining outcomes related to: 1) provider self-reported and observed implementation fidelity of RUBI during sessions, 2) caregiver implementation of RUBI strategies with their child, 3) caregiver satisfaction with the RUBI intervention, and 4) the effects of caregiver implementation of RUBI on child challenging behavior.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

October 3, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

January 23, 2023

Last Update Submit

February 14, 2023

Conditions

Keywords

parent training

Outcome Measures

Primary Outcomes (3)

  • Measurement of Providers' Self-Efficacy during RUBI

    This questionnaire will assess self-efficacy, self-reported proficiency, the comfort level when using RUBI intervention with caregivers and assess changes over time

    Change from Baseline at 2 months, 4 months, 6 months

  • RUBI Implementation fidelity

    This outcome will be assessed in two ways: (1) self-reported questionnaire of implementation fidelity when implementing RUBI program; (2) video/audio recording of the session to assess fidelity

    Change from Baseline at 2 months, 4 months, 6 months

  • Satisfaction with RUBI intervention

    This questionnaire will assess the self-reported satisfaction with RUBI intervention

    Change from Baseline at 2 months

Study Arms (1)

Treatment

EXPERIMENTAL
Behavioral: RUBI

Interventions

RUBIBEHAVIORAL

RUBI teaches caregivers a range of skills to support the building of a behavioral management "toolbox." The intervention emphasizes: 1) tailoring the intervention to the child; 2) identifying behavioral function instead of topography as a means to inform behavioral strategy choice (i.e., targeting what is "driving" the behavior, instead of the behavior itself); 3) decreasing behavioral excess as well as increasing appropriate behaviors; and 4) using positive behavioral supports, such as antecedent management (e.g. use of visual supports), reinforcement, and functional communication strategies as the means to modify behaviors. RUBI uses a behavioral skills training approach, which includes direct instruction, modeling, role-play and practice with feedback in order to train caregivers in the various RUBI skills. Sessions also have accompanying video vignettes that are used to illustrate skills or test parental understanding of session materials.

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
For Study 1 and Study 2, providers must meet the following criteria * actively employed in one of the clinical service programs in the state of Maine * are currently serving or have served a youth with autism and/or intellectual disability in the prior 12 months * able to attend one of the introductory RUBI trainings. For Study 2, caregivers must meet the following criteria: * receiving services from a provider who completed Level 1 RUBI Clinical Training and can provide care in their language of care * have legal custody of an autistic youth between the ages of 3 and 17 with co-occurring challenging behaviors, such as meltdowns, aggression, or difficulties following instructions.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Maine Department of Health and Human Services

Augusta, Maine, 04333, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 24, 2023

Study Start

October 3, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations