Caregiver Skills Training: Comparing Clinician Training Methods

NCT06038799 | Terminated

• 1 other identifier: STUDY23040076
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Parenting

Keywords

Caregiver skills training; Staff training

Outcome Measures

Primary Outcomes (1)

• Change from week 1 (baseline) to week 12 on the Caregivers Skills and Knowledge Measure

  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.

  Week 1 (baseline) versus week 12 (final visit)

Secondary Outcomes (2)

• Change from week 1 (baseline) to week 12 on the Parenting Stress Index.

  Week 1 (baseline) versus week 12 (final visit)

• Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC)

  Week 1 (baseline) versus week 12 (final visit)

Study Arms (2)

Remote staff training

ACTIVE COMPARATOR

Staff will receive 15 hours of remote training followed by 12 weeks of remote supervision (one hour per week).

Behavioral: Caregiver Skills Training (CST)

Face to face staff training

ACTIVE COMPARATOR

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)

Interventions

Caregiver Skills Training (CST) BEHAVIORAL

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.

Face to face staff training; Remote staff training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Autism Speaks: collaborator

Study Sites (2)

UPMC Altoona

Altoona, Pennsylvania, 16601, United States

Location

UPMC Mon Yough

McKeesport, Pennsylvania, 15132, United States

Location

Related Publications (5)

• 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.

  PMID: 36661427 BACKGROUND

• 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.

  PMID: 31393178 BACKGROUND

• 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.

  PMID: 28105548 BACKGROUND

• 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.

  PMID: 34853959 BACKGROUND

• 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.

  PMID: 24958585 BACKGROUND

Study Officials

• Benjamin Handen, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Parents that receive Caregiver Skills Training will be unaware of whether their group leaders were trained/supervised remotely or face-to-face.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: September 15, 2023
• Study Start: September 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (2)