ParentingCSTNCT06038799
Caregiver Skills Training: Comparing Clinician Training Methods
A study testing Caregiver Skills Training (CST) in people with Parenting, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Caregiver Skills Training (CST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Parent()s does not speak / understand English. Given the nature of this study, we are unable to provide translation services.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Altoona
Altoona, Pennsylvania, 16601
UPMC Mon Yough
McKeesport, Pennsylvania, 15132
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting
- Being tested
- Caregiver Skills Training (CST)
- Keywords
- Caregiver skills training, Staff training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Skills Training (CST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote staff training | Active comparator | Staff will receive 15 hours of remote training followed by 12 weeks of remote supervision (one hour per week). Receives: 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). Receives: Behavioral: Caregiver Skills Training (CST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 (baseline) versus week 12 (final visit)
Secondary outcomes (2)
Change from week 1 (baseline) to week 12 on the Parenting Stress Index.
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.
Measured: Week 1 (baseline) versus week 12 (final visit)
Change from week 1 (baseline) to week 12 on the Social Communication Checklist (SCC)
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.
Measured: Week 1 (baseline) versus week 12 (final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start15 Sep 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: poor subject accrual; unable to meet study aims
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks
- Responsible party
- Principal investigator, Benjamin L Handen, PhD, BCBA-D, University of Pittsburgh
- Investigators
- Benjamin Handen, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038799
- Sponsor's protocol ID
- STUDY23040076
- Acronym
- CST
- Status last verified
- Mar 2025
- First submitted
- 19 Jul 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share the study protocol, consent, analysis plan and results upon request by qualified researchers/professionals.
Publications
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.
PubMed 36661427Holly 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.
PubMed 31393178Wainer 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.
PubMed 28105548Sengupta 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.
PubMed 34853959Kasari 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.
PubMed 24958585
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Skills Training: Comparing the Effectiveness of Training Clinicians Via Telehealth and In-Person Training
- ClinicalTrials.gov ID
- NCT06038799
- Acronym / sponsor ID
- CST / STUDY23040076
- Conditions
- Parenting
- Keywords
- Caregiver skills training, Staff training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor subject accrual; unable to meet study aims
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Autism Speaks
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote staff training | Active comparator | Behavioral: Caregiver Skills Training (CST)Staff will receive 15 hours of remote training followed by 12 weeks of remote supervision (one hour per week). |
| Face to face staff training | Active comparator | Behavioral: Caregiver Skills Training (CST)Staff will receive 15 hours of face to face training followed by 12 weeks of face to face supervision (one hour per week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Parent()s does not speak / understand English. Given the nature of this study, we are unable to provide translation services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Face to face staff training, Remote staff training |
Primary outcome
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.
2 secondary outcomes
Change from week 1 (baseline) to week 12 on the Parenting Stress Index.
Time frame: 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)
Results and safety
The study was stopped early (reason given: poor subject accrual; unable to meet study aims). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Results publication: PubMed 36661427Ludwig 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.
- Results publication: PubMed 31393178Holly 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.
- Results publication: PubMed 28105548Wainer 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.
- Results publication: PubMed 34853959Sengupta 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.
- Results publication: PubMed 24958585Kasari 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.
- Individual participant dataSharing planned: Yes. The investigators will share the study protocol, consent, analysis plan and results upon request by qualified researchers/professionals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Handen, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Skills Training (CST) in people with Parenting, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: poor subject accrual; unable to meet study aims). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038799, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.