Living Well With a Disability Curriculum Adaptation Evaluation Plan

September 14, 2023 updated by: Gavin Colquitt, Georgia Southern University
The purpose of this proposal is to implement a joint project with Georgia Southern University and the Effingham County Navigator Team to improve the quality of life of families with a child with a disability in southeast Georgia. The final outcome of this project will be a new curriculum, Living Well Together, which builds on a previous implementation of the Living Well with a Disability curriculum in Bulloch County.

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

First, parent facilitators will be recruited and matched with their peers. Parent facilitators will be members of the Effingham County Navigator Team with a child with a disability. The peer matching resembles the community lay health worker model. The community lay health worker model will reduce the amount of time needed to meet face to face with families. To begin adapting the facilitator training and curriculum, the program directors will work with representatives from the University of Montana Rural Institute on Disabilities to review and update training materials. A representative from the Rural Institute on Disabilities will deliver an online intensive facilitator training. The facilitator training is approximately 15 hours long. The training includes three major components: peer training, facilitator training, and Master "Train the Trainer" training. The project directors will work with the Effingham County Navigator Team to recruit parents. The Navigator Team will recruit five parents as parent facilitators. The parents will work together with the project directors to deliver the adapted curriculum to participating families. With bi-weekly meetings for 10 weeks between parent facilitators and family participants in the home or another desired location. The project directors have already participated in the facilitator training and will serve as mentors to newly trained facilitators. At the end of the online training session, the parent facilitators will be equipped to successfully implement the Living Well curriculum. The project directors will schedule a working meeting before and after the facilitator training to discuss curriculum changes with the Rural Institute on Disabilities representative. Changes in readability are anticipated since the target audience includes adolescents. Curriculum delivery methods will need tailoring to match a family-based approach including activities to be completed at the home at the family and individual levels for parents, siblings, and children. Both GSU faculty and the Navigator team will lead monthly summary meetings to review the adapted content. These meetings will take place at a convenient location in the community as determined by the Navigator team. Pre and post focus groups will take place before and after these monthly meetings at a convenient locale in the community.

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.
39

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Springfield, Georgia, United States, 31329
        • B and B Care Services

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

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Families of with a child (3-50) with any developmental disability

Exclusion Criteria

Family and child are unable to follow directions and participate in curriculum activities.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Living Well with a Disability
The parents will work together with the project directors to deliver the adapted curriculum to participating families. With bi-weekly meetings for 10 weeks between parent facilitators and family participants in the home or another desired location. The project directors have already participated in the facilitator training and will serve as mentors to newly trained facilitators. At the end of the online training session, the parent facilitators will be equipped to successfully implement the Living Well curriculum.
Behavioral: Living Well with a Disability
Implementation of an adapted health promotion program.

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
Global Health
Time Frame: 12 months

Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0

Global Health

  • Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Global Health (PROMIS PGH-7) measures general health, quality of life, physical health, mental health, feeling sad, social health (fun with friends), and parents listening to ideas.
  • Each item is measured on a likert scale from 1 (never) to 5 (always). There is one item for each subscale listed above. A range for each subscale would be 1-5. Typically, results are reported as a whole so the range would be 7 to 35.
  • For each subscale and the scale as a whole the higher the score, the better the global health.
  • Subscales are summed to compute the total score.
12 months

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
Family Relationships
Time Frame: 12 months

Patient Reported Outcomes Measurement Information System Parent Proxy scale v. 1.0

Family Relationships

  • The Family Relationships subscale measures the importance and strength of the family unit perceived by the child in the past four weeks.
  • Each item is measured on a Likert scale from 1 (never) to 4 (always). There are four items in this subscale. The reports are reported as a whole so the range is 4 to 16.
  • The higher the score, the stronger the family relationships.
  • Items are summed for the total score.
12 months
Life Satisfaction
Time Frame: 12 months

Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Life Satisfaction

  • The Life Satisfaction subscale measures quality of life in the past four weeks.
  • Each item is measured on a Likert scale from 1 (not at all) to 5 (very much). There are eight items in this scale. The range for the whole subscale is 8-40.
  • The higher the score, the better quality of life.
  • Each item is summed for the total score.
12 months
Physical Activity
Time Frame: 12 months

Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Physical Activity

  • The Physical Activity subscale reports frequency and intensity of exercise of the child in the past week.
  • Each item is measured on a Likert scale from 1 (no days) to 5 (6-7 days). There are eight items in this subscale. The total range is 8 (no exercise) to 40 (exercising regularly).
  • The higher the score, the more physically active the individual is.
  • The items are summed together for the score.
12 months
Psychological Stress Experiences
Time Frame: 12 months
Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Psychological Stress Experiences
12 months
Peer Relationships
Time Frame: 12 months

Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Peer Relationships

  • The Peer Relationships subscale measures the child's social activity in the last 7 days.
  • Each item is measured on a Likert scale from 1 (never) to 5 (almost always). There are 7 items in the scale. The range is 7 (doesn't interact with friends) to 35 (very socially active).
  • The higher the score the better the relationships.
  • The items are summed together for a total score.
12 months

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.
Georgia Southern University

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: Gavin Colquitt, EdD, Georgia Southern 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.
March 24, 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.
January 15, 2022

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.
January 15, 2022

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 31, 2018

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 25, 2018

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 27, 2018

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.
September 15, 2023

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.
September 14, 2023

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.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • H18234

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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