I-ACQUIRE Webinar for Site PIs and Study Coordinators Sharon Ramey and Warren Lo, I-ACQUIRE PIs Stephanie Deluca and Craig Ramey, Directors for the Treatment Implementation Center Jill Heathcock and Amy Darragh, Directors for the Assessment Center

Agenda for Monthly I-ACQUIRE Webinar: 25 September 2019 12 – 1:00 p.m. 1. Upcoming calendar of events (Sharon Ramey) 2. Therapist study-certification (process and update) – Stephanie DeLuca 3. Assessor study-certification (process and update) – Jill Heathcock 4. Parent Council update – Amy Darragh 5. Overview of Site Readiness Conference calls– Sharon Ramey 6. Q & A (Warren Lo)

12 Clinical Performing Sites Ann Arbor, MI Baltimore, MD Boston, MA Chicago, IL Cincinnati, OH Cleveland, OH Columbus, OH Houston, TX La Jolla, CA New Haven, CT Philadelphia, PA Roanoke, VA

I-ACQUIRE Calendar Updates

I-ACQUIRE Monthly Calls for PIs & Study Coordinators Specific dates for remainder of 2019: Wednesday 23 October (12-1pm EST) Wednesday 13 November (3-4pm EST) Wednesday 18 December 18 (12-1pm EST) All PowerPoints loaded onto I-ACQUIRE Website for “Webinars” Very important to have at least one lead representative and for that person to communicate with others at the local sites about any new information

Annual StrokeNet Meeting To be held in Atlanta on Tuesday 29 October 2019 (all day) Sharon Ramey and Warren Lo will present update on I-ACQUIRE Joe Broderick emphasized that our shared goal is have at least several sites with subjects enrolled and being treated by then Warren Lo has been appointed to the Recovery and Rehabilitation Committee

Child Neurology Society Meeting Upcoming Child Neurology Society is meeting in Charlotte, NC 23-26 October 2019 There will be an I-ACQUIRE meeting FRIDAY 25 October from 12:30 – 1:30pm; Room number TBD; Dr Lo will be available for site specific questions and to answer any questions or concerns Poster #244 “A Multisite Blinded Comparative Efficacy Trial of CIMT Dose Levels and Constraint Variations for 2 – 8 Year Olds with Hemiparetic Cerebral Palsy” will be displayed in the Exhibit Hall (Wednesday 6:00pm – 7:30PM, Thursday 11:30am – 6:00pm, Friday 7:00am – 10:30am)

Webinar for Research Coordinators about Parent Report Tools Research Coordinators either attended or have been invited to view a recording of an Parent Measure Overview on August 23rd. That webinar covered parent measures, and how to facilitate parent completion. An additional webinar is scheduled on September 26th to review scoring procedures for the IMAL and the MacArthur Bates. This will be a one hour review (led by Amy Darragh and Angela Rittler from OSU at the Assessment Center)

Therapist Study-Certification Process In July, all sites submitted scoring from distributed videotapes. Therapists apply the Fidelity of I-ACQUIRE Tool to the videotapes to identify deviations as well as acceptable treatment-compliant therapist-child interactions First round of assessments resulted in 60% approved, 40% needing additional training and re-submission of materials After second webinar training – 81% of all trained therapist now meet study certification Houston – has completed training but not fidelity (study certification) process 91% of therapists who have completed training and study certification have met criteria 2 Therapists will have individualized assistance and further training

12 Clinical Performing Sites: # of Study-Certified Therapists Ann Arbor, MI - 3 Baltimore, MD – 2 Boston, MA - 2 Chicago, IL - 2 Cincinnati, OH - 2 Cleveland, OH - 0 Columbus, OH - 2 Houston, TX - 0 La Jolla, CA – 2 New Haven, CT - 3 Philadelphia, PA - 2 Roanoke, VA - 3 Second Therapist Training Dec. 3rd-6th, 2019 – Open to any site who would like to have additional therapist trained, at site expense, with the exception of Cleveland, OH

Assessment Training and Study-Certification 2 blinded assessors are study certified Model uses self-guided training modules total time is reported at 6 – 20 hours (somewhat higher than anticipated); GMFM *Ideally, most assessors have had considerable standardized assessment experience, including many of the tools in our assessment battery. MAJOR CHANGE: Bayley-4 has been shipped! Ann Arbor, Houston and La Jolla – did you get yours? Early and continuing review of Inter-rater reliability from local sites indicates a lot more work is needed for many of the assessors.

12 Clinical Performing Sites # of Blinded Assessors who have sent in materials (GMFM) Ann Arbor, MI - 2 Baltimore, MD - 0 Boston, MA - 0 Chicago, IL - 0 Cincinnati, OH - 1 Cleveland, OH - 1 Columbus, OH - 3 Houston, TX - 0 La Jolla, CA - 0 New Haven, CT - 0 Philadelphia, PA - 1 Roanoke, VA - 1

12 Clinical Performing Sites # of Blinded Assessors who have sent in materials (Bayley) Ann Arbor, MI - Baltimore, MD - 0 Boston, MA - 0 Chicago, IL - 0 Cincinnati, OH - Cleveland, OH - 0 Columbus, OH - 2 Houston, TX - 0 La Jolla, CA - 0 New Haven, CT - 0 Philadelphia, PA - 0 Roanoke, VA - 1

12 Clinical Performing Sites # of Blinded Assessors who have sent in materials (with a child) Ann Arbor, MI - 0 Baltimore, MD - 0 Boston, MA - 0 Chicago, IL - 0 Cincinnati, OH - Cleveland, OH - 0 Columbus, OH - 3 Houston, TX - 0 La Jolla, CA - 0 New Haven, CT - 0 Philadelphia, PA - 0 Roanoke, VA - 0

Assessment Training and Study Certification (cont’d) Welcome session Electronic office hours (4 group sessions) Individual contact with assessors is active and ongoing Goal: that most sites will be study-certified for assessors by end of October Reminders: All assessment sessions are videotaped in full; the tapes are sent to OSU for centralized review and for scoring for two of the outcome-related measures – namely, the Emerging Behaviors Scale (EBS) and the Use of the Hemiparetic Upper Extremity in Bimanual Activities (from the Mini AHA structured play session)

Parent Council Report Highly active Parent Council Invitations extended to parents from 2 additional sites Preliminary Quarterly I-AQCUIRE Newsletter completed – forwarded to study investigators for review Preliminary Parent Survey topics complete and will now be sent to Craig Ramey and Amy Darragh to transform into survey questions Sensitivity Training emailed to Research Coordinators and Assessors

Site Readiness Calls – Sample form

CTAs and CIRB Updates CTAs -Baltimore (Kennedy-Kreiger Institute) – Pending, all others approved CIRBs approved: Chicago, Cincinnati, Columbus, Houston, New Haven, Philadelphia, and Roanoke CIRBs submitted – approval pending: Ann Arbor, Boston CIRB submitted - site response pending: La Jolla DOES ANYONE NEED HELP? Contacts: Jennifer Golan and Emily Stinson (Regulatory Compliance Specialists)

Site Readiness Calls Ann Arbor, MI – Pending CIRB approval Baltimore, MD – Pending executed CTA; Pending submission of CIRB packet Boston, MA – Pending CIRB approval Chicago, IL – Scheduled 9/30 Cincinnati, OH – Scheduled 9/30 Cleveland, OH - Pending submission of CIRB packet Columbus, OH – Scheduled 10/4 Houston, TX – Scheduling in process La Jolla, CA - Pending CIRB approval New Haven, CT – Scheduled 10/10 Philadelphia, PA - Scheduling in process Roanoke, VA - Completed 09/13

Q and A session