NCT03447119

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

March 24, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

3.8 years

First QC Date

January 31, 2018

Last Update Submit

September 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (5)

  • Family Relationships

    12 months

  • Life Satisfaction

    12 months

  • Physical Activity

    12 months

  • Psychological Stress Experiences

    12 months

  • Peer Relationships

    12 months

Study Arms (1)

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.

Behavioral: Living Well with a Disability

Interventions

Implementation of an adapted health promotion program.

Living Well with a Disability

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

B and B Care Services

Springfield, Georgia, 31329, United States

Location

MeSH Terms

Conditions

Health EducationDevelopmental Disabilities

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorNeurodevelopmental DisordersMental Disorders

Study Officials

  • Gavin Colquitt, EdD

    Georgia Southern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 27, 2018

Study Start

March 24, 2018

Primary Completion

January 15, 2022

Study Completion

January 15, 2022

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations