A Family-centered Teaching Model in Pediatric Occupational Therapy Internship (FACTmodel)

July 19, 2024 updated by: Jung-Jiun Shie

Effects of a Family-centered Teaching Model on Intern's Perceptions and Children's Occupational Performance

Most of the occupational therapy students received the knowledge of family-centered services when they studies in universities, however, the experience of family-centered practice during internships is limited. The purpose is to design a family-centered teaching model and to examine the effects of the teaching model. The positive results showed on students' perceptions and children's occupational performance.

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

The study examined the differences of interns' perceptions of services toward family-centeredness and children' occupational performance between a family-centered teaching (FACT) model and a conventional family approach incorporated in internships. A two-group quasi-experimental design was employed. Participants included 49 interns, 44 caregivers, and 45 children with disabilities under six-year-old. The perceptions of interns toward FCS in both groups were measured using the Chinese version of the "Measure of Processes of Care-Service Provider" (C-MPOC-SP) at the pre- and post- tests. Children' occupational performance in both groups was rated using the "Canadian Occupational Performance Measure" (COPM) for the pre- and post-tests. Interns in the experimental group demonstrated a significant increase in two of the four C-MPOC-SP subscales compared to their counterparts. Children' scores improved significantly in COPM performance subtest for experimental group, but not on the COPM satisfaction subscale.

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.
138

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Veterans General Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Children with developmental delays/disabilities and their caregivers
  2. Children with developmental delays/disabilities under six years old
  3. The caregivers of the children with disabilities are aged 20 years old or older
  4. The caregivers of the children with disabilities or delays can follow the instruction to administer the assessment
  5. Students are participating in internships of the pediatric occupational therapy clinical unit at the hospitals.

Exclusion Criteria:

  • Caregiver suffered from mental illness and had difficulty to complet the study.

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 Assignment
  • 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.
Experimental: family-centered teaching model group
The family-centered teaching group provided knowledge and skills of family-centered services for interns in internship
Behavioral: Family-centered teaching model
The program comprised two parts: (1) Didactic lessons: and (2) Hands-on practice. The didactic lessons were designed to prepare interns' knowledge and skills. The hands-on practice were designed to provide opportunities of family-centered experience to work with caregivers and children.
No Intervention: conventional family approach group
The conventional family approach provided interns to interact with children in internships.

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
The 49 interns' family-centered behaviors including four types of behaviors were measured by the self-reported questionnaire of "Measure of Processes of Care for Service Providers"
Time Frame: at the beginning and the end of the internship; an average of 12 weeks
The "Measure of Processess of Care-Service Provider" can measure four types of famly-centered behaviors such as (1) Showing Interpersonal Sensitivity; (2) Providing General Information; (3) Communicating Specific Information; (4) Treating People Respectfully. The questionnire is a reliable and valid self-reported questionnaire The questionnaire comprises 27 items in which each item has a 7-point Likert scale from 1 (not at all) to 7 (to a very great extent).
at the beginning and the end of the internship; an average of 12 weeks
The performance and satisfaction scales of occupational performance for 45 children in both groups were assessed by a semi-structured interview questionnaire of "Canadian Occupational Performance Measure" reported by their caregivers.
Time Frame: at the beginning and the end of the internship; an average of 12 weeks
The occupational performance assessed by the "Canadian Occupational Performance Measure" includes the performance on the self-care, productivity, and leisure activities. The caregiver is asked to identify the activities that is needed and difficult to be completed by their children. The importance of the five most necessary and difficult activities are scored by each caregiver on a ten-point scoring scale. The performance and satisfaction of the five most necessary, difficult and important activities are scored by each client and caregiver on a 10-point scale. The scores of performance or satisfaction scale were aggregated on the five most necessary, difficult and important activities.
at the beginning and the end of the internship; an average of 12 weeks

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.
Jung-Jiun Shie

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: Jung-Jiun Shie, Dr., National Pingtung University

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.
October 17, 2018

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.
October 16, 2021

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.
October 16, 2021

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).
July 13, 2024

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.
July 19, 2024

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.
July 25, 2024

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.
July 25, 2024

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.
July 19, 2024

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.
July 1, 2024

More Information

Terms related to this study

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.
  • MOST108-2637-H-471-001

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings