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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: contextual one-on-one coaching
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.
Behavioral: Trainig workshop
Ten-hour training workshop.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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