FamilyLive Feasibility and Effectiveness Study

Summary

Children who have been exposed to trauma (defined as physical, sexual or emotional abuse, neglect, exposure to life threatening events, domestic and community violence, parental mental health disorders, substance abuse, and/or incarceration may also have parents who have experienced trauma. Often, unresolved intergenerational trauma makes treatment of children with trauma and its sequelae, including Post Traumatic Stress Disorder, attachment disorders and dysregulation characterized by emotional lability, hyperarousal, and sleep and attention disturbances, difficult to manage. FamilyLive (FL) is a promising treatment approach developed by clinicians at the Kennedy Krieger Family Center (KKFC) over 10 years ago to address the unique needs of families with unresolved and untreated histories of neglect and disrupted attachment who need support to build skills for managing their children's responses and behaviors. FL uses a team approach with a therapist in the room with the family and call-in observations and clinical suggests from a clinician behind a one-way mirror. Through the call-in process the treatment team provides validation, acknowledgement, support and multiple perspectives for the family's experiences. The FL approach works with families to improve parental self-care, stress management, emotional regulation and self-awareness.

Despite its clinical use at the KKFC, the effectiveness of the FL intervention not been systematically evaluated using a randomized design. The proposed preliminary study will use a randomized design to evaluate the feasibility of conducting a larger randomized trial of FL compared to other standard mental health care treatments (SMHC) at the KKFC. We hypothesize that it will be feasible to recruit sufficient numbers of clients for and conduct a randomized controlled trial of FL on a cohort of children exposed to neglect and trauma. We also hypothesize that FL participants will evidence greater reductions in heart rate variability, behavior problems, trauma symptoms, and improvements in functioning compared to participants in the SMHC.

Conditions

• Mood Lability
• PTSD
• Anxiety

Interventions

BEHAVIORAL

FamilyLive

Multi-therapist family mental health treatment for families with a history of intergenerational neglect and trauma

BEHAVIORAL

Standard Mental Health Treatment

Standard trauma-informed mental health treatment

Sponsors & Collaborators

• Substance Abuse and Mental Health Services Administration (SAMHSA)

  collaborator FED

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2016-01-08

Completion

2016-01-08

Countries

• United States

Study Locations