Caregiver Skills Training: Comparing Clinician Training Methods (CST)

March 31, 2025 updated by: Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh

Caregiver Skills Training: Comparing the Effectiveness of Training Clinicians Via Telehealth and In-Person Training

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.

Study Overview

Status

Terminated

Conditions

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • UPMC Altoona
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC Mon Yough

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 (baseline) versus week 12 (final visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 (baseline) versus week 12 (final visit)
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.
Week 1 (baseline) versus week 12 (final visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY23040076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share the study protocol, consent, analysis plan and results upon request by qualified researchers/professionals.

IPD Sharing 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.

IPD Sharing Access Criteria

Interested investigators should contact the PI directly, who will review requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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