NCT03707223

Brief Summary

the objectives of the study is to Evaluate the effectiveness of "The Interfaces Program" to promote person's components, performance and improving the work environment of people with disabilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

April 29, 2017

Last Update Submit

June 23, 2021

Conditions

Keywords

career development, people with disabilities

Outcome Measures

Primary Outcomes (7)

  • proactive behavior Questionnaire (developed for this study)

    proactive behavior during the last week

    A change in proactive behavior measure will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

  • Adult subjective assessment of participation (ASAP)

    subjective experience of participation in meaningful occupations

    A change in subjective experience of participation measure will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

  • Work Behavior Inventory (WBI)

    employer assessment of work behavior and work performance

    A change in work behavior measure will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

  • work self efficacy Questionnaire (WSS-37)

    subjective report of work self efficacy

    A change in work self efficacy measure will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

  • health perception sf 12 Questionnaire Health Perception

    subjective report of health perception

    A change in health perception measure will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

  • career self management - subjective self management perception Questionnaire - developed for this study

    subjective report of career self management

    A change in career self management measure will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

  • perception of environmental work barriers - subjective work barriers perception Questionnaire - developed for this study

    subjective perception of environmental work barriers

    A change in perception of environmental barriers will appear after 9 sessions over 3 month (4 first meeting will be done once a week, and 5 meetings once in two weeks) of intervention, and after 3 month form the end of the intervention

Study Arms (2)

experimental

EXPERIMENTAL

The "interfaces Program"

Behavioral: The Interfaces Program

control group

ACTIVE COMPARATOR

supported employment using the individual placement and support (IPS) model

Behavioral: IPS

Interventions

career development program

experimental
IPSBEHAVIORAL

supported employment using the individual placement and support (IPS) model

control group

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • psychiatric or physical disability
  • years of educations minimum
  • at least 26 score on the Montreal cognitive assessment ( MOCA)
  • working at least 3 month in the open market

You may not qualify if:

  • autistic spectrum disorder (ASD)
  • Developmental Cognitive Disability
  • alcohol or drags comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maya Huber

Tel Aviv, Isarel, 6936468, Israel

Location

Study Officials

  • navah ratzon, prof

    Tel Aviv University

    PRINCIPAL INVESTIGATOR
  • Rachel Gali cinamonp, prof

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Occupational Therapist

Study Record Dates

First Submitted

April 29, 2017

First Posted

October 16, 2018

Study Start

September 1, 2016

Primary Completion

August 1, 2018

Study Completion

February 1, 2020

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations