GAINS Expert Guiding Technology to Coach Life Skill TeachingNCT07203105
GAINS Expert Guiding Technology to Coach Life Skill Teaching
A study testing GAINS expert guiding technology to coach life skill teaching in people with GAINS Expert Guiding Technology to Coach Life Skill Teaching, run by Guiding Technologies Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- GAINS Expert Guiding Technology to Coach Life Skill Teaching
- What is being tested?
- GAINS expert guiding technology to coach life skill teaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Only children ages 3 through 10 years who present with Autism Spectrum Disorder (ASD) will be recruited for this study.
Who cannot join
- No individuals will be excluded or included based on race, ethnicity, or gender
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas
Fayetteville, Arkansas, 72701
Elizabeth R Lorah, Ph.D., (479) 575-7244, lorah@uark.edu
About this study
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.
- Being tested
- GAINS expert guiding technology to coach life skill teaching
- Keywords
- Autism Spectrum Disorder, Technology, Behavior Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAINS expert guiding technology to coach life skill teachingBehavioural
GAINS expert guiding technology to coach life skill teaching
| Study group | Role | What they receive |
|---|---|---|
| GAINS expert guiding technology to coach life skill teaching | Experimental | Not described Receives: Behavioral: GAINS expert guiding technology to coach life skill teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GAINS Expert Guiding Technology to Coach Life Skill TeachingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiding Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203105
- Sponsor's protocol ID
- 1R43MH130298-01
- Other IDs
- 1R43MH130298-01
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SBIR Grant recipients are not required to share data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAINS Expert Guiding Technology to Coach Life Skill Teaching
- ClinicalTrials.gov ID
- NCT07203105
- Acronym / sponsor ID
- 1R43MH130298-01
- Keywords
- Autism Spectrum Disorder, Technology, Behavior Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Guiding Technologies CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAINS expert guiding technology to coach life skill teaching | Experimental | Behavioral: GAINS expert guiding technology to coach life skill teaching |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Only children ages 3 through 10 years who present with Autism Spectrum Disorder (ASD) will be recruited for this study.
Key exclusion criteria (1 listed)
- No individuals will be excluded or included based on race, ethnicity, or gender
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAINS expert guiding technology to coach life skill teachingGAINS expert guiding technology to coach life skill teaching | Behavioural | GAINS expert guiding technology to coach life skill teaching |
Primary outcome
Child independent life skill performance
Time frame: 60 days
The life skill steps (as determined by pre-treatment task analysis) the child performs without caregiver prompts divided by total life skill steps.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. SBIR Grant recipients are not required to share data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAINS expert guiding technology to coach life skill teaching in people with GAINS Expert Guiding Technology to Coach Life Skill Teaching, run by Guiding Technologies Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child independent life skill performance (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.