Strong Families Strong Forces: Supporting Active Duty Fam... | NCT03045159

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

NCT03045159

Sponsor

Boston University

Status

Unknown status

Last Update Posted

Feb 7, 2017Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Deployment

Interventions

Strong Families Strong Forces
Strong Parents

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Mar 31, 2016

First Submission Date that Met QC Criteria

Feb 3, 2017

First Posted Date

Feb 7, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Name	Class
The University of Texas Health Science Center at San Antonio	OTHER
RAND	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Strong Families	Experimental	parenting program	Behavioral: Strong Families Strong Forces
Strong Parents	Active Comparator	self-care program	Behavioral: Strong Parents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Strong Families Strong Forces	Behavioral	Parenting program	Strong Families

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Coparenting Scale	Assesses parents' perception of their own coparenting behavior.	Change from baseline to 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kathering Dondanville, PsyD	Contact	(254) 288-1474
Trenton James, MAJ	Contact	(254) 288-2147

Overall Officials

Name	Affiliation	Role
Ellen DeVoe, Ph. D. LICSW	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
STRONG STAR Research Consortium	Recruiting	Fort Hood	Texas	76544	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided