Promoting Resiliency in Veteran Families With Young Children

NCT04598100 | Completed DMC

• 1 other identifier: R01HD072324-05
• Study Type: interventional
• Target: 199
• Locations: 0 countries
• Sites: N/A

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 (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.

Conditions

Stress, Psychological; Stress Disorders, Traumatic; Regulation, Self; Behavior, Child; Emotional Stress; Trauma, Psychological; Anxiety; Depression

Keywords

resilience; families; children; intervention; deployment

Outcome Measures

Primary Outcomes (10)

• Change in Eyberg Child Behavior Inventory (ECBI) from baseline to 12months

  The Eyberg Child Behavior Inventory (ECBI) will be used to obtain the frequency of problem behaviors (Intensity subscale) and whether or not the behavior is problematic for the parent (Problem subscale). The ECBI has demonstrated strong reliability, including internal consistency (.88-.95), inter-rater reliability (.79-.86), and test-retest reliability (.86-.88). It also has appropriate criterion-related validity. Both of the ECBI subscales are highly correlated with CBCL Externalizing Behavior.

  Baseline and 12months

• Change in Strengths and Difficulties SDQ from baseline to 12 months

  The Strengths and Difficulties Questionnaire (SDQ) is a brief emotional and behavioral screening questionnaire for children and young people. The SDQ consists of 25 items equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior.

  Baseline and 12months

• Change in Spence Child Anxiety Scale-Preschool Version (SCAS) from baseline to 12 months

  The Spence Child Anxiety Scale-Preschool Version (SCAS) Separation Anxiety, General Anxiety, and Fear of Physical Harm subscales will be used to assess child anxiety. The SCAS shows high internal consistency and test-retest reliability and was acceptable in a community sample. Positive mood, negative mood and compliance will be coded from videotaped PCI tasks; anger and compliance will be coded from the videotaped WFI tasks.

  Baseline and 12months

• Change in Brief Symptom Inventory (BSI-18) from baseline to 12 months

  Parental psychological distress will be measured using the Brief Symptom Inventory. The BSI-18 measures somatization, depression, and anxiety as well as the global severity index (GSI), including all 18 items. Anxiety and depression scores were calculated by averaging the six items pertaining to each subscale (Cronbach's α = 0.88, 0.89, respectively). Scores were calculated when no more than two items were missing per subscale.

  Baseline and 12 months

• Change in Patient Health Questionnaire (PHQ9) from baseline to 12 months

  The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. There are two components of the PHQ-9: to assess symptoms and functional impairment to make a tentative depression diagnosis, and to derive a severity score to help select and monitor treatment. Reliability and validity of the PHQ-9 have indicated it has sound psychometric properties. Internal consistency of the PHQ-9 has been shown to be high.

  Baseline and 12 months

• Change in Parenting Stress Index (PSI-SF) from baseline to 12 months

  Parenting stress was assessed using the 36-item Parenting Stress Index- Short Form (PSI-SF). The PSI-SF consists of three subscales: Parental Distress, Parent-Child Dysfuncitonal Interaciton (PC-DysFx), and Difficult Child. The Parental Distress subscale examines the degree of distress parents are experiencing in their parental role and was considered as a measure of parent psychological health (α = 0.89).

  Baseline and 12months

• Change in Posttraumatic Diagnostic Scale (PDS) from baseline to 6 months

  Parent PTSD symptoms were assessed using the four-part Posttraumatic Diagnostic Scale (PDS). This study used the 17-item symptom severity section. Re-experiencing and Arousal scores were calculated by summing the five items pertaining to each subscale, and Avoidance scores by summing the seven items pertaining to the subscale (Cronbach's α = 0.94, 0.92, and 0.92, respectively). Total scores were calculated by summing all17 items (Cronbach's α = 0.96). PDS has high internal consistency and test-retest reliability.

  Baseline and 6 months

• Change in Parental Behavior with Preschooler Q-Sort from baseline to 12 months

  Parents' perceptions of their sensitive parenting behaviors were assessed using nine items from the Parental Behavior with Preschooler Q-Sort, which were adapted as self-report questionnaire items (PBP-Sensitivity); the self-report items have shown predictive validity for a variety of child and parent characteristics.

  Baseline and 12months

• Change in Parent Child Interaction (PCI)/NICHD Qualitative Rating from baseline to 12 months

  Each parent will also participate in a 15 minute videotaped parent-child interaction task based on the NICHD Study of Early Child Care "Three Bag" semi-structured free play procedure. Mothers and fathers will be provided with three different but comparable sets of developmentally appropriate toys, and instructed to play with the toys in a specified order. Qualitative ratings developed for the NICHD Study of Early Child Care will be used to assess parent behavior (sensitivity/supportive presence, intrusiveness, detachment/disengagement, positive regard, and negative regard) Two research assistants will be trained to reliability to code the videotaped parent-child interactions. Dr. Paley has used this coding system in her previous and current research. Approximately 20% of the interactions will be double-coded to assess inter-rater reliability. Coders will be blind to treatment condition.

  Baseline and 12 months

• Change in WFI- Whole Family Interaction/Young Family Interaction Coding System (YFICS) from baseline to 12 months.

  The WFI task will be used to assess family positive affect, negative affect, detachment, intrusiveness, and alliances. Families will be videotaped during a 15-minute play task in which they are asked to build something together with Duplos®. Ratings of the family interaction task will be made from videotapes using the Young Family Interaction Coding System (YFICS). The WFI has been predicted by parental attachment classifications and marital interactions and adequate reliability has been established for the YFICS. Coding will focus on the quality of interactions among all family members, rather than on interactions within any particular dyad.

  Baseline and 12 months

Secondary Outcomes (5)

• Change from baseline to 12 months on Coping Self Efficacy (CSE) measure

  Baseline and 12 months

• Change from baseline to 12 months on Home Observation for Measurement of the Environment Early Childhood Version (HOME)

  Baseline and 12 months

• Change from baseline to 12 months on Ages and Stages Questionnaire: Social Emotional (ASQ:SE)

  Baseline and 12months

• Change from baseline to 12 months on Coparenting Questionnaire

  Baseline and 12 months

• Change from baseline to 12 months on McMaster Family Assessment Device (FAD)

  Baseline and 12months

Study Arms (2)

FOCUS-EC

ACTIVE COMPARATOR

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 \& combat stress reminders, which foster parent-child and family cohesion. The intervention is delivered in six 90-minute sessions in the family home. 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", 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 adjustments made. FOCUS-EC promotes parenting skills and more cohesive family relationships in two key phases: 1) creating a family deployment and reintegration timeline and 2) enhancing parent-child interactions.

Behavioral: FOCUS-EC

Web-Based Family Education

NO INTERVENTION

Families in the WB condition will be provided access to online educational materials covering topics such as typical child development, effects of early childhood separations, common child reactions to family stress, and the importance of self-care. CDM families in this condition will also have access to the standard services that are available to OEF/OIF/OND veterans through the VHA system, TriCare, and California Department of Veterans Affairs.

Interventions

FOCUS-EC BEHAVIORAL

FOCUS-EC

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-active duty OEF/OIF/OND veteran with at least one co-habiting child, ages 3 to 6 years old
• Spouse/partner of OEF/OIF/OND veteran with at least one co-habiting child, ages 3 to 6 years old, can only participate if Veteran is participating
• Co-habiting child (3 to 6 years) of OEF/OIF/OND veteran
• Signed informed consents
• Access to computer with webcam and internet access

You may not qualify if:

• Either parent does not want the child to participate
• Participated in FOCUS-EC while on active duty
• Active psychosis/mania (as assessed by staff)
• Significant child developmental delays (as assessed by staff)
• Families excluded from the study will be provided with a list of online resources.

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Stress, Psychological; Stress Disorders, Traumatic; Self-Control; Child Behavior; Psychological Trauma; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders; Mental Disorders; Social Behavior

Study Officials

• Patricia Lester, MD

  University of California, Los Angeles, Semel Institute

  PRINCIPAL INVESTIGATOR

• Catherine Mogil, PsyD

  University of California, Los Angeles, Semel Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 22, 2020
• Study Start: April 3, 2014
• Primary Completion: January 18, 2017
• Study Completion: June 30, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share