Self-Monitoring Shopping Intervention
Primary Purpose
Intellectual Disability, Down Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-monitoring shopping intervention
Sponsored by
About this trial
This is an interventional treatment trial for Intellectual Disability focused on measuring Shopping, Activities of Daily Living
Eligibility Criteria
Inclusion Criteria:
- Adults with intellectual disability secondary to Down Syndrome
- Members of a community center called GiGi's Playhouse Hillsborough
Exclusion Criteria:
- Severe behavioral disorder that would prevent cooperation with study protocol
Sites / Locations
- GiGi's Playhouse Hillsborough
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shopping group
Arm Description
Participants will receive an 8-week intervention which will include weekly sessions that are delivered in an alternating group-individual format. Sessions will provide participants the opportunity to practice and apply self-monitoring techniques across a variety of shopping tasks and settings to promote generalization and transfer of learning (Phase B).
Outcomes
Primary Outcome Measures
Number of subjects with change in level of assistance post intervention
Shopping Skills Recording Sheet will be used to record the level of assistance (5-point ordinal scale) required by participants to demonstrate targeted shopping skills observed in the community. Completion of the instrument requires 25 minutes. There are five levels:
Independent (I) Client performs the task completely without cueing or assistance
Indirect cueing (IC) Therapist provides general information regarding performance, without explicitly stating what is to be done
Direct cueing (DC) Therapist provides specific instructions or feedback about performance
Partial assistance (PA) Client performs part, but not all of the task
Full assistance (FA) Therapist completes the task for the client in its entirety
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04020302
Brief Title
Self-Monitoring Shopping Intervention
Official Title
The Effect of a Self-Monitoring Shopping Intervention for Adults With Intellectual Disability Secondary to Down Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the effectiveness of a self-monitoring intervention to improve shopping performance in adults with intellectual disability (ID) secondary to Down syndrome (DS). The research question asks, can an 8-week self-monitoring intervention, provided in a community-based setting, increase observable shopping skills in adults with ID secondary to DS?
Detailed Description
Adults with intellectual disability secondary to Down syndrome often have difficulty performing complex activities of daily living, such as shopping. These difficulties may, in part, be influenced by deficits in metacognitive abilities, which include self-monitoring of one's performance. There is evidence that interventions which target self-monitoring skills can improve functional performance in adults and adolescents with traumatic brain injury.
Functional magnetic resonance imaging (fMRI) studies on adults with Down syndrome have demonstrated impairments in metacognitive abilities, resulting from significant volume reduction in the frontal lobes and anterior cingulate cortex. These deficits likely contribute to the difficulties experienced by this population when performing instrumental activities of daily living (IADL), such as shopping. Although metacognitive-focused interventions that address self-monitoring skills have been used to improve functional performance in adults and adolescents with traumatic brain injury, these techniques have not yet been used to improve IADL performance in adults with intellectual disability secondary to Down syndrome.
This 16-week study is a single-subject ABA design across ten participants to determine the effectiveness of a self-monitoring intervention on shopping performance in adults with intellectual disability secondary to Down syndrome. The intervention will span 8 weeks and will include weekly sessions that are delivered in an alternating group-individual format. Sessions will provide participants the opportunity to practice and apply self-monitoring techniques across a variety of shopping tasks and settings to promote generalization and transfer of learning. This study has the potential to provide preliminary information on the effectiveness of a self-monitoring intervention, provided in community-based settings, to increase observable shopping skills in adults with intellectual disability secondary to Down syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Down Syndrome
Keywords
Shopping, Activities of Daily Living
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group: Clinical trials with a single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shopping group
Arm Type
Experimental
Arm Description
Participants will receive an 8-week intervention which will include weekly sessions that are delivered in an alternating group-individual format. Sessions will provide participants the opportunity to practice and apply self-monitoring techniques across a variety of shopping tasks and settings to promote generalization and transfer of learning (Phase B).
Intervention Type
Behavioral
Intervention Name(s)
Self-monitoring shopping intervention
Intervention Description
Intervention will occur once per week for a duration of 8 weeks. The intervention format will alternate between individual and group sessions, so that the first week of intervention will be provided in a group format, the second week will be provided in an individual format, and so forth. Sessions will be 90 minutes in duration. Data will be collected during individual sessions, which will occur every other week. During individual sessions, each participant will meet at the facility for the first 15 minutes, will travel to a local grocery store for 45 minutes, and then reconvene at the facility for the final 30 minutes. Group sessions will follow the same structure; however, all ten participants will be present. Each of the 8 sessions will consist of the following: awareness training; facilitation of strategy generation; facilitation of error detection; reinforcement of self-monitoring techniques; and opportunity for participants to practice self-monitoring techniques.
Primary Outcome Measure Information:
Title
Number of subjects with change in level of assistance post intervention
Description
Shopping Skills Recording Sheet will be used to record the level of assistance (5-point ordinal scale) required by participants to demonstrate targeted shopping skills observed in the community. Completion of the instrument requires 25 minutes. There are five levels:
Independent (I) Client performs the task completely without cueing or assistance
Indirect cueing (IC) Therapist provides general information regarding performance, without explicitly stating what is to be done
Direct cueing (DC) Therapist provides specific instructions or feedback about performance
Partial assistance (PA) Client performs part, but not all of the task
Full assistance (FA) Therapist completes the task for the client in its entirety
Time Frame
Baseline, up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with intellectual disability secondary to Down Syndrome
Members of a community center called GiGi's Playhouse Hillsborough
Exclusion Criteria:
Severe behavioral disorder that would prevent cooperation with study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Gutman, PhD
Organizational Affiliation
Professor of Rehabilitation and Regenerative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
GiGi's Playhouse Hillsborough
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Self-Monitoring Shopping Intervention
We'll reach out to this number within 24 hrs