Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy

Autism Spectrum Disorder Clinical Trial

— TEAMS  

Official title:

Effectiveness of a Multi-Level Implementation Strategy for ASD Interventions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03380078
• Other study ID #: 990914
• Secondary ID: R01MH1198101RO1M
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: August 5, 2027

Study information

• Verified date: February 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of the "Translating Evidence-based Interventions (EBI) for ASD: Multi-Level Implementation Strategy" (TEAMS) model on provider-level implementation outcomes when used to enhance provider training in two evidence-based interventions for children with autism spectrum disorder (ASD). The TEAMS- Leadership Institute (TLI) module includes training to program/school district leaders in implementation of EBI, and the TEAMS Individualized Provider Strategy for Training (TIPS) module applies Motivational Interviewing strategies to facilitate individual provider behavior change. TEAMS will be tested in combination with two clinical interventions in two community service setting contexts (1) AIM HI intervention in mental health programs and (2) CPRT intervention in schools. It is expected that the addition of TLI and / or TIPS will improve use of EBI by community providers.

Description:

Overview of Collaborative R01. The investigators propose to conduct two, coordinated studies testing the impact of the "Translating Evidence-based Interventions for ASD: A Multi-Level Implementation Strategy" (TEAMS). TEAMS focuses on improving implementation leadership, organizational climate (Teams Leadership Institute; TLI), and provider attitudes and engagement (TEAMS Individualized Provider Strategy for Training; TIPS) in order to improve two key implementation outcomes - ASD evidence-based intervention (EBI) fidelity, and subsequent child outcomes. The TLI module applies the LOCI ("Leadership and Organizational Change for Implementation") strategies, and the TIPS module applies MI (Motivational Interviewing) strategies to facilitate individual leader and provider level behavior change. These studies will use a randomized Hybrid implementation/effectiveness, Type 3, trial. Study #1 (PI: L Brookman-Frazee/UCSD) will test the TEAMS model with An Individualized Mental Health Intervention for ASD (AIM HI) in publicly-funded mental health services. Study #2 (PI: A Stahmer/UC Davis) will test TEAMS with Classroom Pivotal Response Teaching (CPRT) in school settings.

The Collaborative R01 mechanism will advance implementation science by allowing the research team to: 1) obtain a sufficient sample size to isolate the impact of individual and combined modules targeting different change mechanisms (implementation leadership/climate, attitudes); examine change mechanisms as mediators of outcomes; and provider background and organizational structure as moderators of outcomes; 2) enhance generalizability by testing TEAMS in combination with two clinical EBI in two public service systems critical for children with ASD; and maximize the diversity of the target population. Each site has unique expertise in one of the two EBI to be tested. The PIs have a strong history of collaboration and a clear management plan.

The Centers for Disease Control (CDC) estimates that 1 in 68 children have ASD. Long term outcomes for this populations are poor and the annual cost in the US is estimated to be $268 billion. Research on the effectiveness of methods to scale up EBI in routine care is critical to meet this growing public health need. The efficacy of a growing number of ASD EBI has been established. Emerging data from AIM HI and CPRT studies support the overall effectiveness of ASD EBI for improving child outcomes only when providers complete training and deliver interventions with fidelity. Unfortunately, adoption and provider training outcomes, considered key implementation outcomes, are variable (e.g., up to 35% of providers in our studies either do not complete training or have poor fidelity). These findings are especially concerning given the link between fidelity and child outcomes and the rapid increase of large-scale usual care implementation of EBI with little attention to training completion or fidelity, even with well-established training and consultation methods. Therefore, testing methods of improving implementation outcomes is key to ensuring positive child-level outcomes when EBI are implemented in routine care.

AIM HI and CPRT data indicate that (1) implementation leadership/climate and (2) provider attitudes towards EBI are promising targets of implementation interventions. The roles of both factors have been indicated for broader patient populations and also in current AIM HI and CPRT projects. As such, the project will apply two, established interventions (LOCI, MI) in the TEAMS model to target these specific mechanisms of change. This study will test the impact of combining standard, EBI-specific training with the two TEAMS modules individually and together on multiple implementation outcomes. A dismantling design will be used to understand the effectiveness of TEAMS and the mechanisms of change across settings and participants. The specific aims and hypotheses are:

1. Test the effectiveness of the TEAMS modules individually and in combination on implementation outcomes when paired with two ASD EBI.

a) Compared to standard ASD EBI training (control) and individual TEAMS modules (LEAD or PROV), the full TEAMS model will lead to more positive implementation outcomes for providers (training completion, fidelity), and children (improvements in targeted symptoms).

2. Test the impact of TEAMS modules on organization and provider level mechanisms of change.

a) TEAMS-LEAD will increase use of implementation leadership strategies and TEAMS-PROV will lead to greater changes in provider attitudes and engagement in EBI training.

3. Identify moderators and mediators of implementation outcomes.

1. Identify provider and organization characteristics that moderate implementation outcomes; and

2. Identify provider and leader level mechanisms of change that mediate implementation outcomes.

Team Enhanced TLI Supplemental study Our supplemental study will examine whether a team-enhanced version of TLI results in better provider and child outcomes outcomes compared to TLI.

Impact: This implementation intervention has the potential to increase quality of care for ASD by improving effectiveness of EBI implementation. The process and modules will be generalizable to multiple service systems, providers, and interventions, providing broad impact in mental health, educational and community services.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1206
• Est. completion date: August 5, 2027
• Est. primary completion date: August 5, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

The combined multi-level sample for both studies will include 74 programs/districts, 148 agency/district leaders, 590 providers (average of 8 per program/district) and 590 parents (1 per provider). It is estimated that an additional 590 participants will complete the 360 Organizational Assessment. Providers are expected to be approximately 85% female and 35% Hispanic. Parent participants are expected to be approximately 80% female and 60% Hispanic.

Mental health programs will be those providing publicly funded psychotherapy services to children in San Diego, Sacramento and LA Counties for in person training and throughout California for distance training. Districts will be those providing public education services to elementary school children with ASD in San Diego, Sacramento and LA Counties for in person training and throughout California for distance training.

Inclusion Criteria for Leaders

(1) Identified as Program Managers at an enrolled site or identified as Program Specialist in an enrolled program/district

Inclusion Criteria for Providers

1. Employed at a participating program/district

2. Employed for at least the next 7 months

3. Has an eligible child on current caseload/classroom (see below)

4. Did not participate in the AIM HI or CPRT effectiveness studies

Inclusion Criteria for Parent Participants (enrolled in a dyad with participating provider)

1. Has a child age 3-13 years.

2. Has a child with a current ASD diagnosis on record or a primary educational classification of autism as indicated in school records

Inclusion Criteria for 360 degree Organizational Assessment

1. Identified as a leader or provider at enrolled site

2. Linked to a participant leader (either as a supervisor or direct report)

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Teams Leadership Institute (TLI)
TLI is training for leaders in how to improve implementation of evidence-based interventions in community settings. TLI includes 5 key components : 1. Assessment: The Implementation Leadership Scale (ILS) and Implementation Climate Scale (ICS) will be completed by first-level leaders participating in the intervention, his/her subordinates (i.e. providers) and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training in implementation leadership Leaders will develop a plan for using specific implementation support strategies. 3. Coaching: Weekly, brief (15-30 min) coaching calls keep leaders on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up : At month 4, leaders attend a 2-hour booster session . 5. Graduation: TLI programs will have a group-based graduation for the leaders and provider trainees at EBI training completion.
• Motivational Enhancement (TIPS for Training)
The TIPS module applies MI principles and strategies to address attitudinal barriers and improve engagement in training. I AIM HI and CPRT trainers (in the TIPS Conditions ) will incorporate MI during training and ongoing consultation/coaching with providers to increase provider engagement and problem solving throughout training: 1. Providers will receive a call designed to provide information about training and the intervention. 2. During the workshop, trainers will assess concerns about participating and will use reflective problem solving to address barriers . Trainers will work with the provider to develop a plan through the use of Planning Worksheets . 3. During each consultation , planning worksheets will be updated collaboratively with the provider. 4. Providers will receive a weekly motivational text to encourage on-going participation.
• Classroom Pivotal Response Teaching (CPRT)
CPRT is a naturalistic behavioral intervention adapted from pivotal response training (PRT) for use during classroom activities to target social, communication, behavior, and learning skills. CPRT is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. CPRT has an established training plan and the training curriculum that follows the manual. Training and coaching including standard EBI training is conducted by MA or postdoctoral level researchers with extensive training and experience with CPRT.
• An Individualized Mental Health Intervention for ASD (AIM HI)
A package of well-established, evidence-based behavioral strategies designed to reduce challenging behaviors in children served in MH service settings. AIM HI is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. AIM HI is a package of evidence-based parent-mediated and child focused strategies, designed to reduce behavior problems in children with ASD ages 5 to 13 served in MH programs. AIM HI has an established training plan and the training curriculum follows the manual. Training and coaching is conducted by MA or postdoctoral level researchers with extensive training and experience with AIM HI.
• Team-Enhanced Teams Leadership Institute (TLI)
TLI-2 enhances TLI training by (a) including additional team members important to EBI implementation (e.g., supervisors, support staff) and (b) including the team in the development of an implementation plan using a team charter process. TLI-2 includes 5 components : 1. Assessment: The Implementation Climate Scale (ICS) will be completed by team members, providers, and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training for the implementation team in implementation climate and development of an implementation plan. 3. Coaching: Bi-monthly, brief (15-30 min) coaching calls keep the team on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up: At month 4, team members attend a 2-hour booster session . 5. Graduation: TLI-2 programs will have a group-based graduation for the leaders and provider trainees at EBI training completion.

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California
United States	University of California, San Diego	San Diego	California
United States	University of California, Los Angeles	Westwood	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Mental Health (NIMH), University of California, Los Angeles, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Training/consultation attendance	Attendance will be tracked by trainers on a program developed form.	Attendance will be tracked throughout intervention training and compiled at Post Intervention (6 months)
Other	Evidence-Based Practice Attitude Scale (EBPAS-15)	This measure includes the 15 items in the original Evidence-Based Practice Attitude Scale (EBPAS-15; Aarons, 2004; Aarons, Glisson, Hoagwood, et al., 2010). The EBPAS assesses provider attitudes toward adoption of EBP in public sector service settings and has been used in substance use disorder treatment, mental health, medical, and social service settings. The EBPAS consists of a higher-order factor/total scale (i.e., total scale score), representing respondents' global attitudes toward adoption of EBPs, and four lower-order factors/subscales. The EBPAS demonstrates good internal consistency reliability (a = .76) and concurrent and predictive validity. Supervisors and providers will complete this measure.	Measures will be completed at PRE (intake) and POST intervention (6 mos)
Other	Implementation Leadership Scales	The Implementation Leadership Scale (ILS; Aarons, Ehrhart, & Farahnak, 2014) includes four subscales that assess the degree to which a leader is knowledgeable, supportive, proactive, and perseverant in implementing EBP. The ILS demonstrates excellent internal consistency reliability (a = .98, 12 items) and convergent and discriminant validity. Providers will complete this measure about their supervisors and executives will complete the measure about the supervisors that they oversee. Each supervisor will also rate him/herself.	Measures will be completed at PRE (intake) and POST intervention (6 mos)
Other	Implementation Climate Scales	The Implementation Climate Scale (ICS) was originally developed as a part of an NIMH measure development grant (R21MH098124, PI: Ehrhart). This 18-item measure assesses the degree to which there is a strategic organizational climate supportive of evidence-based practice implementation. Implementation climate is defined as employees' shared perceptions of the policies, practices, procedures, and behaviors that are rewarded, supported, and expected in order to facilitate effective EBP implementation. The ICS demonstrates excellent internal consistency reliability (a = . 912, 18 items) and convergent and discriminant validity. Providers and supervisors will complete this measure.	Measures will be completed at PRE (intake) and POST intervention (6 mos)
Primary	Provider Training Completion / Certification	Provider training/consultation completion will be measured through completion of requirements for certification, including attendance at workshops and training, completion of appropriate planning tools to program standards and meeting trainer rated fidelity of implementation standards.	Certification will be determine at POST training (6 mos)
Secondary	Child Improvements on The Eyberg Child Behavior Inventory (ECBI)	The ECBI is a 36 item paper-and-pencil rating scales completed by parents that assesses the severity of conduct problems in children as well as the extent to which parents find the behaviors troublesome. It assesses the frequency of disruptive behaviors occurring in the home setting. It provides an Intensity Raw Score and a Problem Raw Score. Internal consistency reliability (Cronbach's alpha): .95 for the Intensity scale and .93 for the Problem scale; (2) Test-retest reliability: .75 to .86 for the Intensity scale and .75 to .88 for the Problem scale; (3) Inter-rater reliability: .86 for the Intensity scale and .79 for the Problem scale.	Child measures will be rated at PRE (intake) and POST intervention (6 mos)
Secondary	Child Improvements on the PDD Behavior Inventory, Parent Extended Version (PDDBI-PX)	PDDBI-PX is a 188-item, paper-and-pencil rating scale completed by parents designed to assess symptoms of autism spectrum disorder and responsiveness to intervention in children. Subscales measure maladaptive (sensory/perceptual approach behaviors; fears; arousal problems; aggressiveness /behavior problems; social pragmatic problems) and adaptive behaviors (social approach; learning, memory and receptive language; phonological skills; pragmatic ability). Domain, composite, and total autism scores are provided. (1) Internal consistency reliability (Cronbach's alpha): ranged from .79 to .97 for all subscales; (2) Test-retest reliability: ranged from .38 to .91 over a 12-month interval; (3) Inter-rater reliability: Parent-Teacher ranged from .55-.67.	Child measures will be rated with the target child at PRE (intake) and POST intervention (6 mos)

External Links

•   study website