Self-Monitoring Shopping Intervention

NCT04020302 | Completed

• 1 other identifier: AAAS5202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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?

Conditions

Intellectual Disability; Down Syndrome

Keywords

Shopping; Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Baseline, up to 8 weeks

Study Arms (1)

Shopping group

EXPERIMENTAL

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

Interventions

Self-monitoring shopping intervention BEHAVIORAL

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.

Shopping group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with intellectual disability secondary to Down Syndrome
• Members of a community center called GiGi's Playhouse Hillsborough

You may not qualify if:

• Severe behavioral disorder that would prevent cooperation with study protocol

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

GiGi's Playhouse Hillsborough

Hillsborough, New Jersey, 08844, United States

Location

MeSH Terms

Conditions

Intellectual Disability; Down Syndrome; Typhus, Endemic Flea-Borne

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Rickettsia Infections; Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Study Officials

• Sharon Gutman, PhD

  Professor of Rehabilitation and Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single Group: Clinical trials with a single arm

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 16, 2019
• Study Start: September 6, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 20, 2019
• Last Updated: January 23, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)