Disabled PersonsNCT04747210
Contextual Coaching Versus Training Workshop for Assistants in Special Education.
A study testing contextual one-on-one coaching and Trainig workshop in people with Disabled Persons and Caregiver, run by Universidad de Zaragoza.
Trial summary
Special Need Assistants/paraprofessionals serve an essential role in special education to support children with multiple disabilities, but they often lack adequate training and supervision. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Disabled Persons, Caregiver
- What is being tested?
- contextual one-on-one coaching and Trainig workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Special Need Assistant of students between 4-21 years of age.
- Speak, read and comprehend Spanish.
- Be available for workshop and one-on-one coaching.
- Able to verbalize changes in their own performance or their students' participation.
- Written consent.
- Present difficulties in Activities of Daily Living (ADLs).
- Have an assistant involved in the study.
- Informed consent signature (parents or legal tutors).
Who cannot join
- Have no students involved in the program.
- Independence in activities of daily living.
- 70 or more points in the Care Dependency Scale for Pediatrics (CDS-P).
About this study
Official title: Improving Students' Participation in Daily Living Skills Through Contextual Coaching One-on-one for Special Needs Assistants.
Special Need Assistants/paraprofessionals serve an essential role in special education to support children with multiple disabilities, but they often lack adequate training and supervision. The study aims to examine the effects of the coaching program for assistants compared to a workshop outside working hours and evaluate the outcomes in students and assistants. The second aim is to measure fidelity implementation of coaching practices and if the intervention was participation-based.
Read the detailed description
This study addresses the training needs of assistants to minimize participation barriers of the students. The schools will be assigned to one of two groups: both groups will receive a 10 hours training workshop; only the intervention group will receive coaching one-to-one. The duration and number of coaching sessions will depend on the caregivers' time available, daily routines, and goals. Coaching sessions will be recorded for the assessment of treatment fidelity.
- Conditions
- Disabled Persons, Caregiver
- Being tested
- contextual one-on-one coaching, Trainig workshop
- Keywords
- Special Need Assistants/paraprofessionals, Coaching, Occupational therapy, Self-care skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contextual one-on-one coachingBehavioural
Training workshop and coaching one-on-one
Trainig workshopBehavioural
Ten-hour training workshop.
| Study group | Role | What they receive |
|---|---|---|
| Trainig workshop and Coaching one-on-one | Active comparator | Ten-hour training workshop that was divided into three sessions outside working hours. Coaching one-on-one in the daily routines and natural environment. Receives: Behavioral: contextual one-on-one coaching |
| Trainig workshop | Active comparator | Assistants receive ten-hour training workshop that was divided into three sessions outside working hours. Receives: Behavioral: Trainig workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The Canadian Occupational Performance Measure (COPM). Students
Caregivers identify activities that are problematic for the child. The caregiver rates the child's performance and satisfaction for each participation goal on a 10-point scale, (1=unable to perform, unsatisfied; 10= performs exceptionally well, extremely satisfied). Differences in scores pre-and post-intervention for both performance and satisfaction are determined independently. A 2-points change in these values is considered clinically meaningful.
Measured: baseline- 3 month after intervention
Change in Goal Attainment Scaling (GAS). Assistants.
Clients identify goals and rate their performance on a 5-point Likert scale ranging from -2 (much less than expected) to +2 (much better than expected). In the baseline, clients can score -1 or -2, and the score "0" is the expected level of success. The 4-point Likert scale is used for quantifying importance (ranging from 0= nothing important to 3= really important) and difficulty (ranging from 0= easy to 3= very difficult). Afterwards, the goal's weight is calculated (importance*difficulty). A mathematical formula allows computation to T-score with a mean of 50 and a standard deviation of 10.
Measured: Baseline - 3 month after intervention
Secondary outcomes (4)
The Coaching Practices Rating Scale.
The Coaching Practices Rating Scale was utilized as a secondary outcome to measure the fidelity of coaching. Its 14 items are based on adults' learning characteristics and coaching practices to determine how the coach use these practices, on a 5-point Likert scale. The scale accepts the rating through video-tapes and has a high degree of construct validity and internal consistency.
Measured: 12 month after intervention
Natural Environments Rating Scale (NERS)
The NERS describes eight categories: 1) setting; 2) activity; 3) type of activity; 4) engagement of child; 5) activity leader; 6) materials; 7) role of the caregiver; 8) the role of the professional. If there is no child-centred activity, grading is discontinued for the remaining categories. Only the last four categories are rated for an overall score that differentiated traditional or participation-based services.
Measured: 12 month after intervention
Change in learning. Social validity
Paraprofessionals were invited to reply to a writing questionnaire. This survey collected information about their training preferences and satisfaction with received training.
Measured: 6 month
Change in transfer and generalization of learning
All paraprofessionals were invited to reply to a semi-structured interview through a phone. This interview collected information about their current employment, the degree in which they had been able to put into practice the skills learned and the challenges for their professional development.
Measured: 19-20 mounths after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study startNov 2016
- Primary completionJun 2017
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disabled PersonsStudies of the same condition, open and under way.
- 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
- This study is a quasi-experimental pretest-posttest design. Repeated measures on participants in both arms (as in an RCT) enable assessment of both within-person changes over time and between-arm differences.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Jose López-de-la-Fuente, Universidad de Zaragoza
- Investigators
- Maria J López-de-la-Fuente, Principal investigator, Departamento de Fisiatría y Enfermería. Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747210
- Sponsor's protocol ID
- COACHvsW
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-de-la-Fuente MJ, Herrero P, Garcia-Foncillas R, Gomez-Trullen EM. Contextual, Client-Centred Coaching Following a Workshop: Assistants Capacity Building in Special Education. Int J Environ Res Public Health. 2021 Jun 11;18(12):6332. doi: 10.3390/ijerph18126332.
PubMed 34208053
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Students' Participation in Daily Living Skills Through Contextual Coaching One-on-one for Special Needs Assistants.
- ClinicalTrials.gov ID
- NCT04747210
- Acronym / sponsor ID
- COACHvsW
- Conditions
- Disabled Persons, Caregiver
- Keywords
- Special Need Assistants/paraprofessionals, Coaching, Occupational therapy, Self-care skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 10 Feb 2021 (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.
Special Need Assistants/paraprofessionals serve an essential role in special education to support children with multiple disabilities, but they often lack adequate training and supervision. The study aims to examine the effects of the coaching program for assistants compared to a workshop outside working hours and evaluate the outcomes in students and assistants. The second aim is to measure fidelity implementation of coaching practices and if the intervention was participation-based.
Detailed description
This study addresses the training needs of assistants to minimize participation barriers of the students. The schools will be assigned to one of two groups: both groups will receive a 10 hours training workshop; only the intervention group will receive coaching one-to-one. The duration and number of coaching sessions will depend on the caregivers' time available, daily routines, and goals. Coaching sessions will be recorded for the assessment of treatment fidelity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a quasi-experimental pretest-posttest design. Repeated measures on participants in both arms (as in an RCT) enable assessment of both within-person changes over time and between-arm differences.
| Arm | Type | Receives |
|---|---|---|
| Trainig workshop and Coaching one-on-one | Active comparator | Behavioral: contextual one-on-one coachingTen-hour training workshop that was divided into three sessions outside working hours. Coaching one-on-one in the daily routines and natural environment. |
| Trainig workshop | Active comparator | Behavioral: Trainig workshopAssistants receive ten-hour training workshop that was divided into three sessions outside working hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Special Need Assistant of students between 4-21 years of age.
- Speak, read and comprehend Spanish.
- Be available for workshop and one-on-one coaching.
- Able to verbalize changes in their own performance or their students' participation.
- Written consent.
Key exclusion criteria (3 listed)
- Have no students involved in the program.
- Independence in activities of daily living.
- 70 or more points in the Care Dependency Scale for Pediatrics (CDS-P).
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 |
|---|---|---|
| contextual one-on-one coachingTraining workshop and coaching one-on-one | Behavioural | Trainig workshop and Coaching one-on-one |
| Trainig workshopTen-hour training workshop. | Behavioural | Trainig workshop |
Primary outcome
Change in The Canadian Occupational Performance Measure (COPM). Students
Time frame: baseline- 3 month after intervention
Caregivers identify activities that are problematic for the child. The caregiver rates the child's performance and satisfaction for each participation goal on a 10-point scale, (1=unable to perform, unsatisfied; 10= performs exceptionally well, extremely satisfied). Differences in scores pre-and post-intervention for both performance and satisfaction are determined independently. A 2-points change in these values is considered clinically meaningful.
Change in Goal Attainment Scaling (GAS). Assistants.
Time frame: Baseline - 3 month after intervention
Clients identify goals and rate their performance on a 5-point Likert scale ranging from -2 (much less than expected) to +2 (much better than expected). In the baseline, clients can score -1 or -2, and the score "0" is the expected level of success. The 4-point Likert scale is used for quantifying importance (ranging from 0= nothing important to 3= really important) and difficulty (ranging from 0= easy to 3= very difficult). Afterwards, the goal's weight is calculated (importance*difficulty). A mathematical formula allows computation to T-score with a mean of 50 and a standard deviation of 10.
4 secondary outcomes
The Coaching Practices Rating Scale.
Time frame: 12 month after intervention
Natural Environments Rating Scale (NERS)
Time frame: 12 month after intervention
Change in learning. Social validity
Time frame: 6 month
Change in transfer and generalization of learning
Time frame: 19-20 mounths after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 34208053Lopez-de-la-Fuente MJ, Herrero P, Garcia-Foncillas R, Gomez-Trullen EM. Contextual, Client-Centred Coaching Following a Workshop: Assistants Capacity Building in Special Education. Int J Environ Res Public Health. 2021 Jun 11;18(12):6332. doi: 10.3390/ijerph18126332.
- Individual participant dataSharing planned: No
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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.
Maria J López-de-la-Fuente principal investigator
Departamento de Fisiatría y Enfermería. Universidad de Zaragoza
Questions about this trial
What is this clinical trial studying?
A study testing contextual one-on-one coaching and Trainig workshop in people with Disabled Persons and Caregiver, run by Universidad de Zaragoza.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in The Canadian Occupational Performance Measure (COPM). Students (time frame: baseline- 3 month after intervention). The study lists 2 primary outcomes in all. 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 NCT04747210, which also lists 1 linked publication.
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 10 Feb 2021.