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

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ClinicalTrials.gov Identifier: NCT03380078
Recruitment Status : Recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
University of California, San Diego
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Teams Leadership Institute (TLI) Behavioral: Motivational Enhancement (TIPS for Training) Behavioral: Classroom Pivotal Response Teaching (CPRT) Behavioral: An Individualized Mental Health Intervention for ASD (AIM HI) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will use a randomized factorial dismantling design to examine the independent and combined effectiveness of the TEAMS modules. MH programs (AIM HI study) and School districts (CPRT study) from San Diego, Sacramento, and LA Counties will be randomized to one of four conditions (STANDARD EBI-specific training only (control condition); TIPS (Motivational Module); TLI (LOCI Implementation Leadership Module).
Masking: Single (Outcomes Assessor)
Masking Description: Coders assessing provider outcomes are masked from study condition and aims.
Primary Purpose: Health Services Research
Official Title: Effectiveness of a Multi-Level Implementation Strategy for ASD Interventions
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard
Programs assigned to the Standard condition will receive standard EBI training only
Behavioral: 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 curricullum 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.

Behavioral: 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.

Experimental: TEAMS Leadership Institute (TLI) ONLY
Programs assigned to the TLI ONLY condition will receive standard EBI training for providers and leaders will participate in TLI.
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.

Behavioral: 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 curricullum 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.

Behavioral: 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.

Experimental: Motivational Enhancement (TIPS for Training) ONLY
Programs assigned to the TIPS ONLY condition will receive enhanced TIPS EBI training for providers.
Behavioral: 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.

Behavioral: 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 curricullum 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.

Behavioral: 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.

Experimental: TIPS + TLI
Programs assigned to the TIPS + TLI condition will receive TIPS EBI training for providers and leaders will participate in TLI
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.

Behavioral: 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.

Behavioral: 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 curricullum 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.

Behavioral: 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.




Primary Outcome Measures :
  1. Provider Training Completion / Certification [ Time Frame: Certification will be determine at POST training (6 mos) ]
    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.


Secondary Outcome Measures :
  1. Child Improvements on The Eyberg Child Behavior Inventory (ECBI) [ Time Frame: Child measures will be rated at PRE (intake) and POST intervention (6 mos) ]
    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.

  2. Child Improvements on the PDD Behavior Inventory, Parent Extended Version (PDDBI-PX) [ Time Frame: Child measures will be rated with the target child at PRE (intake) and POST intervention (6 mos) ]
    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.


Other Outcome Measures:
  1. Training/consultation attendance [ Time Frame: Attendance will be tracked throughout intervention training and compiled at Post Intervention (6 months) ]
    Attendance will be tracked by trainers on a program developed form.

  2. Evidence-Based Practice Attitude Scale (EBPAS-15) [ Time Frame: Measures will be completed at PRE (intake) and POST intervention (6 mos) ]
    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 (α = .76) and concurrent and predictive validity. Supervisors and providers will complete this measure.

  3. Implementation Leadership Scales [ Time Frame: Measures will be completed at PRE (intake) and POST intervention (6 mos) ]
    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 (α = .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.

  4. Implementation Climate Scales [ Time Frame: Measures will be completed at PRE (intake) and POST intervention (6 mos) ]
    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 (α = . 912, 18 items) and convergent and discriminant validity. Providers and supervisors will complete this measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. Districts will be those providing public education services to elementary school children with ASD in San Diego, Sacramento and LA Counties.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380078


Contacts
Contact: Aubyn C Stahmer, PhD 9167030254 astahmer@ucdavis.edu
Contact: Lauren Brookman-Frazee, PhD 8589667703 ext 3587 lbrookman@ucsd.edu

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Melissa Mello, MA    916-703-0402    mmello@ucdavis.edu   
Contact: Deeniece Hatten, BA    9167030468    dchatten@ucdavis.edu   
Principal Investigator: Aubyn Stahmer, PhD         
University of California, San Diego Recruiting
San Diego, California, United States, 92123
Contact: Allison Jobin, PhD    858-966-7703 ext 7148    ajobin@ucsd.edu   
Contact: Maia Feliu, PhD    8589667703    mcfeliu@ucsd.edu   
Principal Investigator: Lauren Brookman-Frazee, PhD         
University of California, Los Angeles Recruiting
Westwood, California, United States, 90095
Contact: Lucia Serio, MA    310-825-9250    lserio@psych.ucla.edu   
Contact: Christopher Gomez    (310) 825-9250    cgomez@psych.ucla.edu   
Principal Investigator: Anna Lau, PhD         
Sponsors and Collaborators
University of California, Davis
University of California, San Diego
University of California, Los Angeles
National Institute of Mental Health (NIMH)

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03380078     History of Changes
Other Study ID Numbers: 990914
R01MH1198101 ( Other Grant/Funding Number: NIMH )
RO1MH1195001 ( Other Grant/Funding Number: NIMH )
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

1. Submit an NIMH Data Archive Data Submission Agreement and work with NDCT staff to develop a data submission schedule and outline data elements to be submitted. 2. Data collection will be carefully organized and documented following best practices for data file management to allow for data sharing. 3. Include appropriate language in subject consent documents to allow for the broad sharing of data through NDCT. 4. Use our existing query to pull the required data fields (i.e. Child first, middle, last name, DOB, City of birth, gender) to obtain the Global Unique Identifier (GUIDs).

5. Descriptive/raw data will be submitted semi-annually (January and June); submission of all other data will be done at the time of publication and/or prior to the end of the grant. Positive and negative results will be shared. In addition to the NDCT, we are open to accepting requests for data use subsequent to publication of primary research findings.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: At completion of study
Access Criteria: we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
Implementation Mechanism
Autism Spectrum Disorder
Children's Mental Health Services
School Services

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders