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Self-Monitoring Shopping Intervention

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ClinicalTrials.gov Identifier: NCT04020302
Recruitment Status : Recruiting
First Posted : July 16, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sharon Gutman, Columbia University

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?

Condition or disease Intervention/treatment Phase
Intellectual Disability Down Syndrome Behavioral: Self-monitoring shopping intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group: Clinical trials with a single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Self-Monitoring Shopping Intervention for Adults With Intellectual Disability Secondary to Down Syndrome
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Shopping group
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).
Behavioral: Self-monitoring shopping intervention
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 Measures :
  1. Number of subjects with change in level of assistance post intervention [ Time Frame: Baseline, up to 8 weeks ]

    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:

    1. Independent (I) Client performs the task completely without cueing or assistance
    2. Indirect cueing (IC) Therapist provides general information regarding performance, without explicitly stating what is to be done
    3. Direct cueing (DC) Therapist provides specific instructions or feedback about performance
    4. Partial assistance (PA) Client performs part, but not all of the task
    5. Full assistance (FA) Therapist completes the task for the client in its entirety



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020302


Contacts
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Contact: Sharon Gutman, PhD 212-305-8703 sg2422@cumc.columbia.edu
Contact: Katherine O'Neill, MS 732-947-9938 kvo2103@cumc.columbia.edu

Locations
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United States, New Jersey
GiGi's Playhouse Hillsborough Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Liz Kepniss    908-829-5331    lkepniss@gigisplayhouse.org   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Sharon Gutman, PhD Professor of Rehabilitation and Regenerative Medicine

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Responsible Party: Sharon Gutman, Professor, Columbia University
ClinicalTrials.gov Identifier: NCT04020302     History of Changes
Other Study ID Numbers: AAAS5202
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sharon Gutman, Columbia University:
Shopping
Activities of Daily Living

Additional relevant MeSH terms:
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Down Syndrome
Intellectual Disability
Syndrome
Disease
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders