Health EducationNCT03447119
Living Well With a Disability Curriculum Adaptation Evaluation Plan
A study testing Living Well with a Disability in people with Health Education and Community Health Services, run by Georgia Southern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Education, Community Health Services, Health Services for Persons With Disabilities
- What is being tested?
- Living Well with a Disability
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2018to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families of with a child (3-50) with any developmental disability
Who cannot join
- Family and child are unable to follow directions and participate in curriculum activities.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Education, Community Health Services, Health Services for Persons With Disabilities, Developmental Disabilities
- Being tested
- Living Well with a Disability
- Medical subject headings
- Health Education, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Well with a DisabilityBehavioural
Implementation of an adapted health promotion program.
| Study group | Role | What they receive |
|---|---|---|
| Living Well with a Disability | Experimental | 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. Receives: Behavioral: Living Well with a Disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Health
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.
Measured: 12 months
Secondary outcomes (5)
Family Relationships
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.
Measured: 12 months
Life Satisfaction
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.
Measured: 12 months
Physical Activity
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.
Measured: 12 months
Psychological Stress Experiences
Patient Reported Outcomes Measurement Information System Parent Proxy scale v 1.0 Psychological Stress Experiences
Measured: 12 months
Peer Relationships
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start24 Mar 2018
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Southern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gavin Colquitt, Georgia Southern University
- Investigators
- Gavin Colquitt, EdD, Principal investigator, Georgia Southern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447119
- Sponsor's protocol ID
- H18234
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2018
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Well With a Disability Curriculum Adaptation Evaluation Plan
- ClinicalTrials.gov ID
- NCT03447119
- Acronym / sponsor ID
- H18234
- Conditions
- Health Education, Community Health Services, Health Services for Persons With Disabilities, Developmental Disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Georgia Southern UniversityUniversity, hospital or other
- Study start
- 24 Mar 2018 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Living Well with a Disability | Experimental | Behavioral: Living Well with a DisabilityThe 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Families of with a child (3-50) with any developmental disability
Key exclusion criteria (1 listed)
- Family and child are unable to follow directions and participate in curriculum activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living Well with a DisabilityImplementation of an adapted health promotion program. | Behavioural | Living Well with a Disability |
Primary outcome
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.
5 secondary outcomes
Family Relationships
Time frame: 12 months
Life Satisfaction
Time frame: 12 months
Physical Activity
Time frame: 12 months
Psychological Stress Experiences
Time frame: 12 months
Peer Relationships
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Colquitt, EdD principal investigator
Georgia Southern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Well with a Disability in people with Health Education and Community Health Services, run by Georgia Southern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Health (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.