CompletedNot Applicable

Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention

United States171 participantsStarted 2020-01-31

Plain-language summary

The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE) * The parent/caregiver must be at least 18 years old * The child must between the ages of 3 and 12 years old * The child has a diagnosis of FASD or has confirmed PAE * The child has lived with the parent/caregiver for at least 4 months and is expected to remain in the home for at least 1 year * The parent/caregiver lives in the United States * The parent/caregiver has a smartphone with iOS or Android operating system Exclusion Criteria: * The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English) * There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data) * The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up

Timeframe: baseline to 3-month follow-up

Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up

Timeframe: baseline to 3-month follow-up

Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up

Timeframe: baseline to 3-month follow-up

Family Needs Questionnaire Baseline to 3-Month Follow-up

Timeframe: baseline to 3-month follow-up

Trial details

NCT IDNCT04194489

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-31

Results submitted2022-07-22

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up

Timeframe: baseline to 3-month follow-up

Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up

Timeframe: baseline to 3-month follow-up

Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up

Timeframe: baseline to 3-month follow-up

Family Needs Questionnaire Baseline to 3-Month Follow-up

Timeframe: baseline to 3-month follow-up