Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04598100 |
Other study ID # |
R01HD072324-05 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 3, 2014 |
Est. completion date |
June 30, 2018 |
Study information
Verified date |
October 2020 |
Source |
University of California, Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Family-centered prevention services for civilian dwelling military (CDM) families & children
are rarely available in civilian communities or often framed around mental disorders and
family deficits. As of June 2010, over 1 million military service members from various
military conflicts have become veterans. Wartime deployments can adversely impact the
psychological health of children as well as marital relationships, parent-child relationships
& overall family functioning. Although young children in CDM families may never have to cope
with another parental deployment, their families may continue to struggle with the lasting
effects of wartime deployment that cannot be ameliorated by singularly treating the service
member. There is a need for family-centered preventive interventions that effectively build
resilience and mitigate war deployment-related family difficulties, especially given the
potential adverse emotional & developmental impact of deployment separations and
reintegration stress on young children and their parents. To address this need, this study
proposes to test the efficacy of FOCUS-EC (Families OverComing Under Stress for Early
Childhood), an established strength-based, family-centered preventive intervention that is
culturally sensitive and socially accepted by active duty military communities & has
promising program evaluation data. A randomized control trial will be conducted with 200 CDM
families with young children, ages 3 to 5 years, recruited from Los Angeles & surrounding
counties (200 veterans, 150 spouses, and 300 children). CDM families will be randomized to
the FOCUS-EC intervention condition (n=100 families; 100 veterans, 75 spouses, 150 children)
or web-based educational materials condition (n=100 families; 100 veterans, 75 spouses, and
150 children) and assessed at baseline, 3, 6, & 12 months. It is hypothesized that in the
FOCUS-EC condition: 1) children will exhibit more positive social-emotional & behavioral
outcomes & developmental competencies than children in the comparison condition, 2) families
will exhibit more positive family environment, improved parenting, enhanced parent-child
relationships, & fewer parent psychological health problems than families in the comparison
condition. The investigators also aim to explore potential moderating effects of child
health/development risk, military & deployment/separation history, exposure to combat/trauma
during deployment, and veteran & spouse/partner background factors.
Description:
In Phase I, the investigators modified FOCUS-EC for CDM families with young children, and
developed a platform for the web-based educational materials. The intervention manual,
training materials and assessments were also finalized. The research team already has
well-developed manuals for FOCUS-EC, including an intervention manual, technical assistance
manual, and training curriculum that have been used for various settings. Existing materials
have been customized for CDM families and will be housed online. Materials will include
information about child development and common reactions to early separations, as well as
deployment and family stress. The team also has extensive experience developing online
education for military families (for example, see www.focusproject.org). Online educational
information is a common governmental strategy to serve CDM families; the proposed design
enables a rigorous comparison of a facilitator-led interactive intervention (FOCUS-EC) to the
provision of standardized online resources. Finally in Phase 1, to ensure that FOCUS-EC would
meet the unique needs of CDM families, intervention sessions were modified and conducted with
CDM families. The investigators believe that this customization with a small group of CMD
families has been sufficient to identify the emerging needs of CDM families (e.g., challenges
associated with the transition to civilian life, renegotiating family roles more permanently,
shifting control or power between parents, reestablishing family routines and rituals, and
redefining family relationships), incorporate culturally sensitive language that is common to
this population, and tailor the FOCUS-EC for a home visit delivery model. Themes, current
concerns, and language identified were incorporated into the FOCUS-EC for CDM families
protocol. A similar approach was used to ensure that language used in FOCUS-EC was
appropriate for various branches of the service in the preliminary work. The finalized
intervention manual and training includes protocols and back-up procedures for clinical
emergencies and ethical issues, as documented in the current technical assistance manual.
Phase 2:
All families will complete a baseline assessment, consisting of questionnaires, brief
interviews, and family observational tasks.
After the baseline assessment, the family will be randomized into either the FOCUS-EC
condition or a web-based education condition. Simple block randomization will be done.
Families will be assigned to either the intervention or web-based resources control condition
using a computer-generated randomization list with block sizes of 2, 4, and 6. The code for
this randomization process can be found at:
http://biostat.mc.vanderbilt.edu/wiki/Main/BlockRandomizationwithRandomBlockSizes. No
stratification will be done for gender, age, site, etc.
Participants who are randomized to the web-based education condition will be provided with an
account and password to a study-developed/supported website that will provide online
resources with content comparable to and consistent with FOCUS-EC intervention sessions. That
is, web-based materials will provide information on parent-child communication, emotion
regulation, problem-solving, stress management, and family resilience. Participants will not
be required to utilize these resources; they may access this website as often as they choose
and implement the information and strategies as they wish.
These families will also complete the exact same assessments as those families in the
intervention condition. In addition, they will answer a questionnaire assessing various
aspects of the web-based resources (e.g., usefulness, ease of use/navigation, frequency of
use, etc.).
Participants who are randomized to the FOCUS-EC condition will participate in six
intervention sessions.
The FOCUS-EC protocols and measures have been finalized, programmed, and tested, and informed
consent protocols were developed. FOCUS-EC will be delivered using a tele-health 6 session
manualized protocol. Sessions will be led by trained, Master's level facilitators leading
virtual home visiting sessions. FOCUS-EC is framed within a skill-building and
relationship-strengthening psycho-educational model that integrates research on traumatic
stress, child development, and the military-developed combat operational stress continuum
model for prevention. FOCUS-EC provides developmental guidance, parent education, and key
resilience skills that promote positive individual and family coping, including emotional
regulation, problem solving, goal setting, communication, and management of deployment and
combat stress reminders, which foster parent-child and family cohesion. The intervention is
delivered in six 45-90-minute sessions in the family's home via a computer, internet
connection, and webcam . Each session is structured with a check-in, review of the previous
week's "home activity," primary activity and discussion, selection of a new "home activity"
for the week, and a closing check-out. The family learns and practices the skills during the
sessions, commits to practicing the skills during the week, and reports on their experiences
the following session so that skills can be reinforced and any necessary adjustments can be
made. FOCUS-EC promotes parenting skills and more cohesive family relationships in two key
phases: 1) creating a family deployment timeline and 2) enhancing parent-child interactions
(see figure 3). In the first phase, parents develop a family deployment narrative which
fosters understanding, communication, mutual support, and positive co-parenting across the
parenting dyad (session 1 and 2). This stage begins with a web-based family psychological
health "check-in" utilizing innovative programming already established by this team, and
utilized by families in service settings. This check-in serves to assist the facilitator and
the family in identifying strengths and areas of concern in the initial session through use
of standardized psychological health screening instruments (see Appendix). Parents set goals
for what they are motivated to achieve during program participation. Parents also recount a
narrative timeline for their deployment/separation and reintegration history. Through
perspective taking and active listening, parents bridge estrangements and enhance their
understanding of their child's reactions to deployments and separations, co-parenting, and
family leadership. In the second phase, parents work on enhancing parent-child interactions
in a series of parent-only education and parent-child practice sessions. In these alternating
sessions, parents model and help their children with emotional identification and
communication; learn and practice basic play, attunement, and relationship-enhancement
strategies; increase awareness of trauma, loss, and separation reminders that impact
effective parenting; practice behavior management techniques; elicit a developmentally
appropriate narrative of their child's experiences; and plan for the future.
The study team has experience with a number of innovative technologies designed to deliver
in-home preventive interventions utilizing a virtual delivery platform, including a secure
in-home "teleprevention" platform. This platform has been implemented through a service
delivery model pilot and has demonstrated the feasibility of remote/virtual home visits,
including a video-teleconferencing platform which enables participants to access sessions
using secure software (e.g., "Go To Meeting"). In home access to computers and internet in
this population is high; thus, it anticipated that this will not be a barrier to enrollment
and participation. All core intervention components and activities have been adapted for
remote delivery platform modifications, intervention training, delivery and technical support
manuals.