Fetal Alcohol Spectrum DisordersNCT04194489
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
A study testing FMF Connect 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 parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- FMF Connect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2020to 31 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Feasibility Trial of the FMF Connect Mobile Health Intervention
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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- FMF Connect
- 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.
FMF ConnectOther
The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement.
| Study group | Role | What they receive |
|---|---|---|
| FMF Connect Intervention | Experimental | Not described Receives: Other: FMF Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Measured: baseline to 3-month follow-up
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Measured: baseline to 3-month follow-up
Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Measured: baseline to 3-month follow-up
Family Needs Questionnaire Baseline to 3-Month Follow-up
The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Measured: baseline to 3-month follow-up
Secondary outcomes (2)
Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up
Participants are asked at follow-up to rate how much their self-care practices have changed over the last 3 months on a 5-point scale ranging from "A lot less self-care (1)" to "A lot more self-care (5)." A score of 3 equates to no change.
Measured: 3-month follow-up
Mean App Quality Score on Mobile App Rating Scale: User Version
The mobile app rating scale includes a measure of users perception of app quality. There are 16 items contributing to this score, each rated on a scale from 1 to 5. Total app quality score is presented as a mean with range of 1 to 5, with higher scores reflecting greater perceived quality of the app. .
Measured: 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start31 Jan 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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
- 171 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
- NCT04194489
- Sponsor's protocol ID
- 4433
- Other IDs
- U01AA026104
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2019
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of the FMF Connect Mobile Health Intervention
- ClinicalTrials.gov ID
- NCT04194489
- Acronym / sponsor ID
- 4433
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Posted 4 Nov 2022
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMF Connect Intervention | Experimental | Other: FMF Connect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| FMF ConnectThe FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement. | Other | FMF Connect Intervention |
Primary outcome
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
Time frame: baseline to 3-month follow-up
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
Time frame: baseline to 3-month follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
Time frame: baseline to 3-month follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Family Needs Questionnaire Baseline to 3-Month Follow-up
Time frame: baseline to 3-month follow-up
The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
2 secondary outcomes
Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up
Time frame: 3-month follow-up
Mean App Quality Score on Mobile App Rating Scale: User Version
Time frame: 3-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.
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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 FMF Connect 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 7 inclusion and 3 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 11 Dec 2023. 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 Nov 2022). 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?
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up (time frame: baseline to 3-month follow-up). 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 11 Dec 2023.