Clinical trial NCT06038799: Caregiver Skills Training: Comparing Clinician Training Methods
Official title: Caregiver Skills Training: Comparing the Effectiveness of Training Clinicians Via Telehealth and In-Person Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parenting
Keywords: Caregiver skills training
Staff training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2023-09-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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. Also added was an additional research question in which face-to-face CST sessions with remote CST sessions were compared.

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.

Eligibility 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.

Primary outcomes:
measure: Change from week 1 (baseline) to week 12 on the Caregivers Skills and Knowledge Measure
timeFrame: Week 1 (baseline) versus week 12 (final visit)
Secondary outcomes:
measure: Change from week 1 (baseline) to week 12 on the Parenting Stress Index.
timeFrame: Week 1 (baseline) versus week 12 (final visit)
measure: Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC)
timeFrame: Week 1 (baseline) versus week 12 (final visit)
Other outcomes:
Locations:
city: Altoona
country: United States
facility: UPMC Altoona
state: Pennsylvania
city: McKeesport
country: United States
facility: UPMC Mon Yough
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Benjamin Handen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.