CST: Caregiver Skills Training: Comparing Clinician Training Methods

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT06038799
Collaborator
Autism Speaks (Other)
35
2
2
3.5
17.5
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Caregiver Skills Training (CST)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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.The investigators will be comparing two types of training/supervision models. One will be provided remotely and one will be provided face-to-face.
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
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

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 [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. [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 Vineland Adaptive Behavior Scales (VABS) [Week 1 (baseline) versus week 12 (final visit)]

    To assess adaptive skills with regard to communication, socialization, daily living skills, and motor skills. Raw scores are converted to standard scores (range 20-140). The mean standard score is 100 with a standard deviation of 15. The higher the standard score, the better the adaptive behavior skills.

  3. Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC) [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.

  4. Week 12 score on the Caregiver Diary [Week 1 (baseline) versus week 12 (final visit)]

    To assess the extent to which caregivers are using the strategies they learned. Four questions address caregiver adherence and 2 address caregiver competence. Each is rated on a 1 to 5 scale (range 6 to 30 points) with higher scores indicating greater use of strategies.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 UPMC Altoona Altoona Pennsylvania United States 16601
2 UPMC Mon Yough McKeesport Pennsylvania United States 15132

Sponsors and Collaborators

  • University of Pittsburgh
  • Autism Speaks

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin L Handen, PhD, BCBA-D, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT06038799
Other Study ID Numbers:
  • STUDY23040076
First Posted:
Sep 15, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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, Professor, University of Pittsburgh

Study Results

No Results Posted as of Sep 21, 2023