NCT05207956

Brief Summary

In partnership with a digital health software company, the University research team created two versions of a mobile application to help behavioral health technicians (BHT's) who work with students with autism collect data. The first version comprises a basic electronic platform for data collection. The second version has the same basic electronic platform for data collection, plus additional features designed to increase motivation to collect data and ease the burden of data collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 7, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

November 24, 2021

Results QC Date

May 30, 2023

Last Update Submit

March 4, 2025

Conditions

Keywords

Data collectionautismBehavioral Health Technician (BHT)behavioral economicsimplementationimplementation strategyimplementation scienceTherapeutic Support Staff (TSS)

Outcome Measures

Primary Outcomes (3)

  • The Difference in Data Collection Consistency Between Groups Across Three Weeks

    Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period. These metrics were captured via web analytics in partnership with our digital health company.

    Three-week trial period

  • The Difference in Data Collection Completion Between Groups Across Three Weeks

    Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period. These metrics were captured via web analytics in partnership with our digital health company.

    Three-week trial period

  • The Difference in Data Collection Timeliness Between Groups Across Three Weeks

    Consistency was the percentage of intervals in which aides entered data per session with children during each school day, across a three week period. These metrics were captured via web analytics in partnership with our digital health company.

    Three-week trial period

Secondary Outcomes (6)

  • Intentions for Implementors

    Assessed at baseline and end of 3-week trial period

  • System Usability Scale

    Three-week trial period

  • Attitudes for Implementors

    Assessed at baseline and end of 3-week trial period

  • Perceived Norms for Implementors

    Assessed at baseline and end of 3-week trial period

  • Descriptive Norms for Implementors

    Assessed at baseline and end of 3-week trial period

  • +1 more secondary outcomes

Study Arms (2)

Enhanced Electronic Platform

EXPERIMENTAL

A basic electronic platform for data collection that contains additional features designed to increase motivation to collect data and ease of data collection.

Behavioral: Behavioral economics strategiesOther: Electronic platform

Electronic Platform Not Enhanced

ACTIVE COMPARATOR

A basic electronic platform for data collection.

Other: Electronic platform

Interventions

Behavioral economics features designed to increase motivation to collect data and ease of data collection on the electronic platform.

Enhanced Electronic Platform

Electronic platform to collect data

Electronic Platform Not EnhancedEnhanced Electronic Platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be working as a paraprofessionals or behavioral health technicians
  • Currently providing individual support to children with autism
  • Currently providing services in Philadelphia preschools, schools, day cares, or homes.

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Dr. David Mandell
Organization
University of Pennsylvania

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After consenting to participate in the trial, participants will be randomized in pairs to one of the two study arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

January 26, 2022

Study Start

September 9, 2021

Primary Completion

June 21, 2022

Study Completion

June 21, 2022

Last Updated

March 7, 2025

Results First Posted

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations