Caregiver Skills Training: Comparing Clinician Training Methods (CST)

• ClinicalTrials.gov Identifier: NCT06038799
• Recruitment Status: Recruiting
• First Posted: September 15, 2023
• Last Update Posted: February 26, 2024
• Sponsor: University of Pittsburgh
• Collaborator: Autism Speaks
• Information provided by (Responsible Party): Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

Study Description

Brief Summary:

Caregiver Skills Training (CST) is an evidence-based intervention for parents of young children with developmental disabilities that was developed through a collaboration between Autism Speaks and the World Health Organization. The intervention is typically offered by Facilitators who are trained and supervised by CST Master Trainers. This study seeks to use a remote training model to compare two training and supervision processes. One group, comprised of facilitators from rural settings, will be trained and supervised by two master trainers from the University of Pittsburgh using a remote training model. A second group, comprised of facilitators from an agency serving primarily low-income households and located near Pittsburgh, will be trained and supervised in a face-to-face manner. Both groups will initially receive ten 90-minute training sessions over a 2-month period and will subsequently receive 1 hour per week of supervision while conducting their first 12-session CST group. Outcome measures will include assessment of change in caregiver stress and didactic skills as well as improvement in each child's communication/social skills, functional skills, and overall behavior. We have also added an additional research question in which we compare face-to-face CST sessions with remote CST sessions.

Condition or disease	Intervention/treatment	Phase
Parenting	Behavioral: Caregiver Skills Training (CST)	Not Applicable

Detailed Description:

There are two aspects to this study: First, the investigators will compare two training and supervision processes. One group, comprised of facilitators from rural settings, will be trained and supervised by two master trainers from the University of Pittsburgh Medical Center (UPMC) Center for Autism and Developmental Disorders (CADD). A second group, comprised of facilitators from an agency serving primarily low-income households and located near Pittsburgh, PA, will be trained and supervised in a face-to-face manner. Both groups will receive 15 hours of training spread over the course of 2-3 months (in summer 2023). The focus of these sessions will be to introduce and train staff on the CST model, ensure their understanding of the curriculum, and to help them gain proficiency in administration. During the training phase, both groups will practice administration of activities and will be provided feedback. The master trainers will also assist the newly trained facilitators in navigating recruitment and organization of their first CST groups. Upon initiation of the CST groups, facilitators will receive 1 hour of supervision per week, either in person or via TEAMS. Supervision will extend over the 9 group sessions and 3 home visits per family (fall 2023). These supervision sessions will allow the facilitators to ask questions, obtain feedback, and troubleshoot any challenges. The investigators will also collect pre and post measures (baseline and week 12) from the parents participating in the CST groups to determine if the type of training provided to the facilitators (face-to-face versus remote) impacted parent progress. We have also added an additional research question in which we compare face-to-face CST sessions with remote CST sessions.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The investigators will be comparing two types of training/supervision models. One will be provided remotely and one will be provided face-to-face. In addition, investigators will compare two types of treatment: face-to-face sessions versus remote sessions.
• Masking: Single (Care Provider)
• Masking Description: Parents that receive Caregiver Skills Training will be unaware of whether their group leaders were trained/supervised remotely or face-to-face.
• Primary Purpose: Treatment
• Official Title: Caregiver Skills Training: Comparing the Effectiveness of Training Clinicians Via Telehealth and In-Person Training
• Actual Study Start Date: September 15, 2023
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Remote staff training; Staff will receive 15 hours of remote training followed by 12 weeks of remote supervision (one hour per week).	Behavioral: Caregiver Skills Training (CST); The investigators are comparing the relative efficacy of CST between a CST group led by clinicians trained and supervised remotely versus a group led by clinicians trained an supervised face-to-face.
Active Comparator: Face to face staff training; Staff will receive 15 hours of face to face training followed by 12 weeks of face to face supervision (one hour per week).	Behavioral: Caregiver Skills Training (CST); The investigators are comparing the relative efficacy of CST between a CST group led by clinicians trained and supervised remotely versus a group led by clinicians trained an supervised face-to-face.

Outcome Measures

Primary Outcome Measures :

1. Change from week 1 (baseline) to week 12 on the Caregivers Skills and Knowledge Measure [ Time Frame: Week 1 (baseline) versus week 12 (final visit) ]
   eEvaluates change in caregiver skills and knowledge related to session content as well as caregiver confidence. There are 28 skills questions (scored on a scale of 1-5) with a score range fomr 28-140 (with higher scores indicating greater skills). The Confidence scale consists of 9 items (scored 1-5) with scores ranging from 9-45. Higher scores indicate greater confidence.

Secondary Outcome Measures :

1. Change from week 1 (baseline) to week 12 on the Parenting Stress Index. [ Time Frame: Week 1 (baseline) versus week 12 (final visit) ]
   To assess parental distress, parent-child dysfunctional interaction, and child challenges. There are 36 items and 3 subscales (12 items per subscale). Subscales include Parent Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. There is also a Total Stress Score. Each item is scored on a 1-5 scale. Range for each subscale is 12-60 points; Total Score is 36-180 points. Scores are converted to percentiles. Percentiles of 15-80 are "typical stress;" 81-89 are "high stress;" and >89 are "clinically significant stress." Higher percentiles indicate higher levels of stress.
2. Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC) [ Time Frame: Week 1 (baseline) versus week 12 (final visit) ]
   To assess social communication abilities, specifically social engagement (15 items), expressive language form (15 items), expressive language function (15 items), receptive language (8 items) imitation (6 items, and pla (11 items). Items are scored on a 3-point scale ("usually," = 3 points; "sometimes," = 2 points; or "rarely" = 1 point). The range for all 70 items is 70-210 points. The higher the score, the greater the child's abilities.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

Parents who

• Have a child ages 2-9 with a developmental disability and/or autism
• Able to be served by one of the three UPMC sites
• Able to attend 12 sessions. Group sessions are at the clinic site and the individual sessions may be done virtually or in person.

Exclusion Criteria:

• Parent()s does not speak / understand English. Given the nature of this study, we are unable to provide translation services.

Contacts and Locations

Contacts

Contact: Benjamin Handen; 14122355452; handenbl@upmc.edu

Contact: Charmaine Stillano; 14122255174; StillanoC@upmc.edu

Locations

United States, Pennsylvania

UPMC Altoona; Recruiting

Altoona, Pennsylvania, United States, 16601

Contact: Shannon Tronzo

UPMC Mon Yough; Recruiting

McKeesport, Pennsylvania, United States, 15132

Contact: Kirsten Yaggi

Sponsors and Collaborators

University of Pittsburgh

Autism Speaks

Investigators

• Principal Investigator: Benjamin Handen, PhD; University of Pittsburgh

More Information

Publications of Results:

Ludwig NN, Suskauer SJ, Rodgin S, Chen J, Borda A, Jones K, Lahey S, Slomine BS. Outcome Measurement in Children With a History of Disorders of Consciousness After Severe Brain Injury: Telephone Administration of the Vineland Adaptive Behavior Scales, Third Edition, and Glasgow Outcome Scale-Extended Pediatric Revision. Pediatr Crit Care Med. 2023 Feb 1;24(2):e76-e83. doi: 10.1097/PCC.0000000000003121. Epub 2022 Dec 16.

Holly LE, Fenley AR, Kritikos TK, Merson RA, Abidin RR, Langer DA. Evidence-Base Update for Parenting Stress Measures in Clinical Samples. J Clin Child Adolesc Psychol. 2019 Sep-Oct;48(5):685-705. doi: 10.1080/15374416.2019.1639515. Epub 2019 Aug 8.

Wainer AL, Berger NI, Ingersoll BR. Brief Report: The Preliminary Psychometric Properties of the Social Communication Checklist. J Autism Dev Disord. 2017 Apr;47(4):1231-1238. doi: 10.1007/s10803-016-3026-8.

Sengupta K, Shah H, Ghosh S, Sanghvi D, Mahadik S, Dani A, Deshmukh O, Pacione L, Dixon P, Salomone E; WHO-CST team; Servili C. World Health Organisation-Caregiver Skills Training (WHO-CST) Program: Feasibility of Delivery by Non-Specialist Providers in Real-world Urban Settings in India. J Autism Dev Disord. 2023 Apr;53(4):1444-1461. doi: 10.1007/s10803-021-05367-0. Epub 2021 Dec 1.

Kasari C, Lawton K, Shih W, Barker TV, Landa R, Lord C, Orlich F, King B, Wetherby A, Senturk D. Caregiver-mediated intervention for low-resourced preschoolers with autism: an RCT. Pediatrics. 2014 Jul;134(1):e72-9. doi: 10.1542/peds.2013-3229.

• Responsible Party: Benjamin L Handen, PhD, BCBA-D, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT06038799
• Other Study ID Numbers: STUDY23040076
• First Posted: September 15, 2023
• Last Update Posted: February 26, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The investigators will share the study protocol, consent, analysis plan and results upon request by qualified researchers/professionals.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: The study protocol, consent form, and statistical analysis plan are available now (as of 9/8/23).The investigators hope to complete the data analysis by late spring 2024 (within 1 year of study completion) and will make a CSR available at that time.
• Access Criteria: Interested investigators should contact the PI directly, who will review requests.

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

Keywords provided by Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh:

Caregiver skills training; Staff training