- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045159
Strong Families Strong Forces: Supporting Active Duty Families With Very Young Children
February 3, 2017 updated by: Boston University
Supporting Military Families With Young Children Throughout the Deployment Lifecycle
The purpose of this research is to evaluate the efficacy of the Strong Families Strong Forces Parenting Program compared to a parental self-care (Strong Parents) condition in a sample of 150 Active Duty Families with children ages birth to 5 years.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The overall aim of this research is to adapt and evaluate the efficacy of a parenting program compared to a parental self-care program for Active Duty families.
A sample of 150 Active Duty families with young children who have a parent scheduled to deploy in the next six months will be recruited to participate.
Families will be assigned either to receive the Strong Families Strong Forces Parenting Program, designed to reduce the impact of deployment separation on parenting stress and co-parenting, or to the Strong Parents Self-Care program, designed to support parents to focus on the importance of self-care throughout the deployment cycle.
Investigators will compare the two groups on parenting stress, quality of parent-child relationships, parenting/co-parenting, and family and child well-being.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Fort Hood, Texas, United States, 76544
- Recruiting
- STRONG STAR Research Consortium
-
Contact:
- Katherine Dondanville, PsyD
- Phone Number: 254-288-1474
-
Contact:
- Trenton James
- Phone Number: (254) 288-2147
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cohabitating couple with at least one child age birth to 5 years old in which one parent is active duty and is scheduled to deploy within the next 6 months
- Anticipated deployment time must be at least six months and excludes separations due to the Service Member attending a school
- Anticipate that non-deploying parent will remain in the area during the deployment
- Both parents are willing to consent to study participation
- DEERS -eligible
- 18 years or older
- English-speaking
- The parent remaining at home to care for the children anticipates remaining within 30 miles of Fort Hood to be seen in home, otherwise will need to be seen in office
- Anticipate that both parents will remain in the area for at least three months after redeployment to complete intervention and follow-up assessment
Exclusion Criteria:
- Any family member with a significant medical or psychiatric condition requiring a higher level of care than can be provided by the study/comparison protocols
- Active psychosis or mania
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Strong Families
parenting program
|
Parenting program
|
|
Active Comparator: Strong Parents
self-care program
|
self-care program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Stress Index (PSI)
Time Frame: Change from baseline to 24 months
|
Assesses parenting stress in three domains: parental distress, parent-child dysfunctional interaction, and difficult child.
|
Change from baseline to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coparenting Scale
Time Frame: Change from baseline to 24 months
|
Assesses parents' perception of their own coparenting behavior.
|
Change from baseline to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ellen DeVoe, Ph. D. LICSW, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
March 31, 2016
First Submitted That Met QC Criteria
February 3, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Estimate)
February 7, 2017
Last Update Submitted That Met QC Criteria
February 3, 2017
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- W81XWH-14-2-0123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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