Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
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|ClinicalTrials.gov Identifier: NCT04194489|
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fetal Alcohol Spectrum Disorders||Other: FMF Connect||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Trial of the FMF Connect Mobile Health Intervention|
|Actual Study Start Date :||January 31, 2020|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
|Experimental: FMF Connect Intervention||
Other: FMF Connect
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.
- Mean Effect size in Eyberg Child Behavior Inventory [ Time Frame: baseline to 3 months ]The Eyberg Child Behavior Inventory measures the intensity of child behavior problems, scores have a mean of 50 and a standard deviation of 10 with higher scores indicating worse outcomes. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Parenting Sense of Competence scale for satisfaction [ Time Frame: baseline to 3 months ]The Parenting sense of competence scale measures satisfaction with parenting and ranges from 9 to 54 with higher scores indicating better outcomes. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Parenting Sense of Competence scale for efficacy [ Time Frame: baseline to 3 months ]The Parenting sense of competence scale measures how effective parents feel they are and ranges from 7 to 42 with higher scores indicating worse outcomes. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Family Needs Questionnaire [ Time Frame: baseline to 3 months ]The family needs questionnaire measures the degree to which family needs are met and ranges from 0-4 with 4 indicating more needs are met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in self-care confidence [ Time Frame: baseline to 3 months ]The self-care confidence scale ranges from 1-5 with 5 indicating greater confidence in self-care.
- Mean Mobile app rating tool [ Time Frame: 3 months ]The mobile app tool measures users perception of app quality and ranges from 4-20 with higher scores reflecting greater perceived quality of the app.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194489
|Contact: Christie Petrenko, PhDfirstname.lastname@example.org|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Christie Petrenko, PhD 585-275-2991 email@example.com|