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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194489
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Christie Petrenko, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorders Other: FMF Connect Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Christie Petrenko, PhD 585-275-2991 christie_petrenko@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Christie Petrenko, PhD    585-275-2991    christie_petrenko@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Responsible Party: Christie Petrenko, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04194489    
Other Study ID Numbers: 4433
U01AA026104 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: It will be available once the data is collected and will be available indefinitely.
URL: http://www.cifasd.org/data-sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders