NCT04747210

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

January 30, 2021

Last Update Submit

February 5, 2021

Conditions

Keywords

Special Need Assistants/paraprofessionalsCoachingOccupational therapySelf-care skills

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline - 3 month after intervention

Secondary Outcomes (4)

  • The Coaching Practices Rating Scale.

    12 month after intervention

  • Natural Environments Rating Scale (NERS)

    12 month after intervention

  • Change in learning. Social validity

    6 month

  • Change in transfer and generalization of learning

    19-20 mounths after intervention

Other Outcomes (1)

  • Classification of goals and adaptations

    6 month

Study Arms (2)

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.

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.

Behavioral: Trainig workshop

Interventions

Training workshop and coaching one-on-one

Trainig workshop and Coaching one-on-one

Ten-hour training workshop.

Trainig workshop

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have no students involved in the program.
  • Present difficulties in Activities of Daily Living (ADLs).
  • Have an assistant involved in the study.
  • Informed consent signature (parents or legal tutors).
  • Independence in activities of daily living.
  • or more points in the Care Dependency Scale for Pediatrics (CDS-P).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Maria J López-de-la-Fuente

    Departamento de Fisiatría y Enfermería. Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two external assessors will measure the fidelity of the implementation of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist. Departamento de Fisiatría y Enfermería

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 10, 2021

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

February 1, 2019

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share