Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
Feasibility Study of the My Health Coach App for Adults With Fetal Alcohol Spectrum Disorders (FASD)
Verified date | October 2023 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mt. Hope Family Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 8-item measure of subjective well-being. The Intellectual Disability Version uses more concrete item wording and a 5-point visual scale. Ratings are summed and range from 8 to 40. Higher scores reflect better perceived well-being. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks | |
Primary | 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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks | |
Primary | Mean change in competence 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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks | |
Primary | Mean change in relatedness 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, with summed scores ranging from 8 to 40. 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. | Baseline to 6 Weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Completed |
NCT01961050 -
Preventing FAS/ARND in Russian Children
|
N/A | |
Recruiting |
NCT05108974 -
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
|
Phase 2 | |
Completed |
NCT02457676 -
Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
|
N/A | |
Recruiting |
NCT06005181 -
The Synchrony Study: Examining Music Training for Children With FASD
|
N/A | |
Completed |
NCT04571463 -
Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area
|
||
Completed |
NCT03361293 -
Cognitive Training and tDCS for Children With FASD
|
N/A | |
Recruiting |
NCT05534568 -
The Oklahoma Parent-Child Assistance Program
|
N/A | |
Recruiting |
NCT05456321 -
CIFASD 5 tDCS and Cognitive Training
|
N/A | |
Completed |
NCT01911299 -
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
|
Phase 2 | |
Recruiting |
NCT04332172 -
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
|
N/A | |
Recruiting |
NCT05960461 -
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
|
N/A | |
Terminated |
NCT03852550 -
READYorNot[TM] Brain-Based Disabilities Trial
|
N/A | |
Completed |
NCT02735473 -
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
|
Phase 2 | |
Completed |
NCT03782935 -
Nutritional Risk Factors for FASD in Ukraine
|
N/A | |
Not yet recruiting |
NCT04918043 -
Alcohol Use During Pregnancy in Finland According to Meconium Samples
|
||
Completed |
NCT04072809 -
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
|
||
Completed |
NCT01149538 -
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
|
Phase 1/Phase 2 | |
Completed |
NCT05028517 -
Efficacy Trial of the FMF Connect Mobile Health Intervention
|
N/A | |
Completed |
NCT04194489 -
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
|
N/A |