Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598100
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-01
Brief Title:
Promoting Resiliency in Veteran Families With Young Children
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Promoting Resiliency in Veteran Families With Young Children
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOCUS-EC
Brief 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 n100 families 100 veterans 75 spouses 150 children or web-based educational materials condition n100 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 healthdevelopment risk military deploymentseparation history exposure to combattrauma during deployment and veteran spousepartner background factors
Detailed 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 wwwfocusprojectorg 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 eg 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 httpbiostatmcvanderbilteduwikiMainBlockRandomizationwithRandomBlockSizes 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-developedsupported 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 eg usefulness ease of usenavigation 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 Masters 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 familys home via a computer internet connection and webcam Each session is structured with a check-in review of the previous weeks 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 deploymentseparation and reintegration history Through perspective taking and active listening parents bridge estrangements and enhance their understanding of their childs 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 childs 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 remotevirtual home visits including a video-teleconferencing platform which enables participants to access sessions using secure software eg 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
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 httpbiostatmcvanderbilteduwikiMainBlockRandomizationwithRandomBlockSizes 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-developedsupported 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 eg usefulness ease of usenavigation 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 Masters 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 familys home via a computer internet connection and webcam Each session is structured with a check-in review of the previous weeks 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 deploymentseparation and reintegration history Through perspective taking and active listening parents bridge estrangements and enhance their understanding of their childs 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 childs 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 remotevirtual home visits including a video-teleconferencing platform which enables participants to access sessions using secure software eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None