GAINS Expert Guiding Technology to Coach Life Skill Teaching | NCT07203105

Studies
GAINS Expert Guiding Technology to Coach Life Skill Teaching

NCT07203105

Sponsor

Guiding Technologies Corporation

Status

Recruiting

Last Update Posted

Oct 2, 2025Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

GAINS Expert Guiding Technology to Coach Life Skill Teaching

Interventions

GAINS expert guiding technology to coach life skill teaching

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R43MH130298-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2025Actual

Primary Completion Date

May 31, 2026Estimated

Completion Date

May 31, 2026Estimated

First Submitted Date

Sep 23, 2025

First Submission Date that Met QC Criteria

Sep 30, 2025

First Posted Date

Oct 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2025

Last Update Posted Date

Oct 2, 2025Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Based on proven techniques in operant conditioning, the expert behavior guiding functionality in GAINS to teach life skills will be evaluated. Behavior practitioners will develop task analyses that break down complex life skills into simpler component steps and then enter these tasks into the GAINS system. In a similar way to navigation systems for drivers, GAINS will provide behavioral navigation for caregivers implementing ABA therapy programs. Using the GAINS app on a tablet or smartphone, caregivers will receive automatically updated visual and audio behavioral guidance, that includes what to do, when to do it, and detailed step-by-step guidance on how to execute ABA therapy programs.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GAINS expert guiding technology to coach life skill teaching	Experimental		Behavioral: GAINS expert guiding technology to coach life skill teaching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GAINS expert guiding technology to coach life skill teaching	Behavioral	GAINS expert guiding technology to coach life skill teaching	GAINS expert guiding technology to coach life skill teaching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child independent life skill performance	The life skill steps (as determined by pre-treatment task analysis) the child performs without caregiver prompts divided by total life skill steps.	60 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Only children ages 3 through 10 years who present with Autism Spectrum Disorder (ASD) will be recruited for this study.

Exclusion Criteria:

No individuals will be excluded or included based on race, ethnicity, or gender

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas	Recruiting	Fayetteville	Arkansas	72701	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

SBIR Grant recipients are not required to share data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided