NCT03045159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

February 7, 2017

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

March 31, 2016

Last Update Submit

February 3, 2017

Conditions

Keywords

deployment cyclemilitary familypreventionstressmilitary childparentingcoparenting

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Coparenting Scale

    Change from baseline to 24 months

Study Arms (2)

Strong Families

EXPERIMENTAL

parenting program

Behavioral: Strong Families Strong Forces

Strong Parents

ACTIVE COMPARATOR

self-care program

Behavioral: Strong Parents

Interventions

Parenting program

Strong Families
Strong ParentsBEHAVIORAL

self-care program

Strong Parents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

STRONG STAR Research Consortium

Fort Hood, Texas, 76544, United States

RECRUITING

Study Officials

  • Ellen DeVoe, Ph. D. LICSW

    Boston University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathering Dondanville, PsyD

CONTACT

Trenton James, MAJ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcomes assessor blinded to study condition
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

February 7, 2017

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

February 7, 2017

Record last verified: 2016-03

Locations