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

Deployment Clinical Trial

Official title:

Supporting Military Families With Young Children Throughout the Deployment Lifecycle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03045159
• Other study ID #: W81XWH-14-2-0123
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2016
• Last updated: February 3, 2017
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2016
• Source: Boston University
• Contact: Kathering Dondanville, PsyD
• Phone: (254) 288-1474
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deployment

Intervention

Behavioral:
• Strong Families Strong Forces
Parenting program
• Strong Parents
self-care program

Locations

Country	Name	City	State
United States	STRONG STAR Research Consortium	Fort Hood	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Boston University	RAND, The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parenting Stress Index (PSI)	Assesses parenting stress in three domains: parental distress, parent-child dysfunctional interaction, and difficult child.	Change from baseline to 24 months
Secondary	Coparenting Scale	Assesses parents' perception of their own coparenting behavior.	Change from baseline to 24 months