- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747210
Contextual Coaching Versus Training Workshop for Assistants in Special Education.
February 5, 2021 updated by: Maria Jose López-de-la-Fuente, Universidad de Zaragoza
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
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
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria assistants:
- 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.
Exclusion Criteria assistants:
- Have no students involved in the program.
Inclusion Criteria students:
- Present difficulties in Activities of Daily Living (ADLs).
- Have an assistant involved in the study.
- Informed consent signature (parents or legal tutors).
Exclusion Criteria students:
- Independence in activities of daily living.
- 70 or more points in the Care Dependency Scale for Pediatrics (CDS-P).
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Trainig workshop and Coaching one-on-one
Ten-hour training workshop that was divided into three sessions outside working hours.
Coaching one-on-one in the daily routines and natural environment.
|
Training workshop and coaching one-on-one
|
|
ACTIVE_COMPARATOR: Trainig workshop
Assistants receive ten-hour training workshop that was divided into three sessions outside working hours.
|
Ten-hour training workshop.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline- 3 month after intervention
|
|
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.
|
Baseline - 3 month after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Coaching Practices Rating Scale.
Time Frame: 12 month after intervention
|
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.
|
12 month after intervention
|
|
Natural Environments Rating Scale (NERS)
Time Frame: 12 month after intervention
|
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.
|
12 month after intervention
|
|
Change in learning. Social validity
Time Frame: 6 month
|
Paraprofessionals were invited to reply to a writing questionnaire.
This survey collected information about their training preferences and satisfaction with received training.
|
6 month
|
|
Change in transfer and generalization of learning
Time Frame: 19-20 mounths after intervention
|
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.
|
19-20 mounths after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Classification of goals and adaptations
Time Frame: 6 month
|
The types of goals and adaptations were classified according to daily living activities, such as using the toileting, eating, feeding, hygiene and grooming, dressing, functional mobility, and others (miscellanea).
Accommodations or adaptations to enhance children's participation were registered during and after the intervention as a) not necessary, b) natural for the child or easy to acquire, c) a rehabilitation device, or d) an architectonic/extensive modification.
The adaptations were analyzed as an independent element in the goals that improved performance two or more points in the COPM.
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria J López-de-la-Fuente, Departamento de Fisiatría y Enfermería. Universidad de Zaragoza
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.
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)
November 1, 2016
Primary Completion (ACTUAL)
June 1, 2017
Study Completion (ACTUAL)
February 1, 2019
Study Registration Dates
First Submitted
January 30, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (ACTUAL)
February 10, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- COACHvsW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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