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Trial record 2 of 58 for:    Young and Strong

Strong Families Strong Forces: Supporting Active Duty Families With Very Young Children

This study is currently recruiting participants.
Verified March 2016 by Boston University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03045159
First Posted: February 7, 2017
Last Update Posted: February 7, 2017
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.
Collaborators:
The University of Texas Health Science Center at San Antonio
RAND
Information provided by (Responsible Party):
Boston University
  Purpose
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.

Condition Intervention
Deployment Behavioral: Strong Families Strong Forces Behavioral: Strong Parents

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
outcomes assessor blinded to study condition
Primary Purpose: Prevention
Official Title: Supporting Military Families With Young Children Throughout the Deployment Lifecycle

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Coparenting Scale [ Time Frame: Change from baseline to 24 months ]
    Assesses parents' perception of their own coparenting behavior.


Estimated Enrollment: 300
Study Start Date: March 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strong Families
parenting program
Behavioral: Strong Families Strong Forces
Parenting program
Active Comparator: Strong Parents
self-care program
Behavioral: Strong Parents
self-care program

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT03045159


Contacts
Contact: Kathering Dondanville, PsyD (254) 288-1474
Contact: Trenton James, MAJ (254) 288-2147

Locations
United States, Texas
STRONG STAR Research Consortium Recruiting
Fort Hood, Texas, United States, 76544
Contact: Katherine Dondanville, PsyD    254-288-1474      
Contact: Trenton James    (254) 288-2147      
Sponsors and Collaborators
Boston University
The University of Texas Health Science Center at San Antonio
RAND
Investigators
Principal Investigator: Ellen DeVoe, Ph. D. LICSW Boston University
  More Information

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03045159     History of Changes
Other Study ID Numbers: W81XWH-14-2-0123
First Submitted: March 31, 2016
First Posted: February 7, 2017
Last Update Posted: February 7, 2017
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Boston University:
deployment cycle
military family
prevention
stress
military child
parenting
coparenting