Fetal Alcohol Spectrum DisordersNCT05604014
Feasibility Study of the My Health Coach App for Adults With FASD
A study testing My Health Coach in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- My Health Coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years or older
- Have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
- Have conversational fluency in English
- Own an smartphone
Who cannot join
- Unable to complete measures or interviews in English
- Do not have a smartphone
- Under 18
- Do not have an FASD or history or prenatal alcohol exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- My Health Coach
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Health CoachBehavioural
My Health Coach is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.
| Study group | Role | What they receive |
|---|---|---|
| My Health Coach | Experimental | Participants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. Receives: Behavioral: My Health Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version
The Personal Well-Being Index (PWI) is an 7-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are averaged and the mean total is reported ranging from 1 to 5. Higher scores reflect better perceived well-being.
Measured: Baseline to 6 Weeks
Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Autonomy sub-scale measures how much a person feels they have choice in what they do in their everyday life.
Measured: Baseline to 6 Weeks
Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Competence sub-scale measures how much a person feels they are successful or do a good job on things in their life.
Measured: Baseline to 6 Weeks
Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Relatedness sub-scale measures how much a person feels connected to other people in their life.
Measured: Baseline to 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start21 Mar 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christie Petrenko, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604014
- Sponsor's protocol ID
- 00007749
- Other IDs
- UH2AA029050
- Status last verified
- Sep 2024
- First submitted
- 28 Oct 2022
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be deposited within the Collaborative Initiative on FASD (CIFASD) Central Repository and the National Institute on Alcohol Abuse and Alcoholism Data Archive as required by grant regulations. CIFASD Data Sharing policies and data access request information can be found at: https://cifasd.org/data-sharing/. NIAAA-DA access can be found at: https://nda.nih.gov/niaaa/
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
- ClinicalTrials.gov ID
- NCT05604014
- Acronym / sponsor ID
- 00007749
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal of the app is to provide adults with useful information and tools to help manage their health and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| My Health Coach | Experimental | Behavioral: My Health CoachParticipants receive the My Health Coach app and try it on their personal smartphones for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 18 years or older
- Have a fetal alcohol spectrum disorder (FASD) or history of prenatal alcohol exposure
- Have conversational fluency in English
- Own an smartphone
Key exclusion criteria (4 listed)
- Unable to complete measures or interviews in English
- Do not have a smartphone
- Under 18
- Do not have an FASD or history or prenatal alcohol exposure
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 |
|---|---|---|
| My Health CoachMy Health Coach is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive. | Behavioural | My Health Coach |
Primary outcome
Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version
Time frame: Baseline to 6 Weeks
The Personal Well-Being Index (PWI) is an 7-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are averaged and the mean total is reported ranging from 1 to 5. Higher scores reflect better perceived well-being.
Mean Change in Autonomy Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Autonomy Sub-scale
Time frame: Baseline to 6 Weeks
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Autonomy sub-scale measures how much a person feels they have choice in what they do in their everyday life.
Mean Change in Competence Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Competence Sub-scale
Time frame: Baseline to 6 Weeks
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Competence sub-scale measures how much a person feels they are successful or do a good job on things in their life.
Mean Change in Relatedness Ratings From Baseline to 6-week Follow-up on the Basic Psychological Need Satisfaction and Frustration Scale - Relatedness Sub-scale
Time frame: Baseline to 6 Weeks
The Basic Psychological Needs Satisfaction and Frustration Scale (BPNSF) is a 24-item scale assessing both satisfaction and frustration relating to the three basic psychological needs identified in self-determination theory: autonomy, competence, and relatedness. Items are rated on a 5-point scale from 1 "not at all true" to 5 "completely true." Each sub-scale has 8 items. Scores were averaged across items with reported mean ranging from 1 to 5. Higher scores reflect higher satisfaction or need being met to a higher degree. The Relatedness sub-scale measures how much a person feels connected to other people in their life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified participant data will be deposited within the Collaborative Initiative on FASD (CIFASD) Central Repository and the National Institute on Alcohol Abuse and Alcoholism Data Archive as required by grant regulations. CIFASD Data Sharing policies and data access request information can be found at: https://cifasd.org/data-sharing/. NIAAA-DA access can be found at: https://nda.nih.gov/niaaa/
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Health Coach in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Subjective Well-being From Baseline to 6-week Follow-up on the Personal Well-Being Index - Intellectual Disability Version (time frame: Baseline to 6 Weeks). The study lists 4 primary outcomes in all. 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 4 Oct 2024.