Clinical trial NCT04020302: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Down Syndrome
Keywords: Shopping
Activities of Daily Living
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group: Clinical trials with a single arm
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects with change in level of assistance post intervention
timeFrame: Baseline, up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hillsborough
country: United States
facility: GiGi's Playhouse Hillsborough
state: New Jersey
Study officials:
affiliation: Professor of Rehabilitation and Regenerative Medicine
name: Sharon Gutman, PhD
role: PRINCIPAL_INVESTIGATOR
References: