FamilyLive Feasibility and Effectiveness Study

Children who have been exposed to neglect often have parents who experienced their own
childhood neglect and/or trauma (defined as childhood physical, sexual or emotional abuse,
exposure to life threatening events, domestic and/or community violence, parental mental
health disorders, substance abuse, and/or incarceration). These parental experiences of
neglect and trauma during childhood are associated with disengaged and ineffective parenting
behaviors and disrupted attachment processes between the parent and their own child.
Disrupted attachment can result in the child exhibiting physiological dysregulation and
behavior problems, which pose barriers to the child's academic and social
success/development. Often, unresolved intergenerational trauma makes treatment of children
with trauma and its sequelae, including Posttraumatic 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 (Family Center) 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 Family
Center, the effectiveness of FL has never been systematically evaluated using a randomized
design.

This study will systematically evaluate the feasibility of conducting a randomized clinical
trial of FL versus standard mental health care at the Family Center for children with a
history of neglect and their caregivers who also have a history of childhood neglect, with or
without trauma. Caregivers are defined as any adult who assumes primary responsibility for
the child's daily care in the home environment, and may include a biological parent, adoptive
parent, grandparent, aunt/uncle, sibling who has reached the age of majority who is the
primary caretaker of the child client, etc. Evaluation methods include standardized
instruments and EKG administered at baseline, 3, 6, and 12 months.

Study Objectives:

Primary objective: To examine the feasibility of recruiting and conducting the proposed
intervention and evaluation procedures on a cohort of children exposed to neglect and their
caregivers using a randomized design.

Secondary objective: Examine the effects of FL on heart rate variability, behavior, post
traumatic stress disorder symptoms, and functioning.

Tertiary objective: To examine differences in treatment outcomes (trauma symptoms, behavior
problems, child functioning, parent behavior, etc.) between clients who receive FamilyLive
and clients who receive SMHC at the Family Center.

Inclusion criteria:

- Children, ages 5-17 years 11 months,

- enrolled in treatment at KKFC and each child's primary caregiver will be invited to
participate if the child continues to exhibit behavior dysregulation (CBCL of > 60)
and/ or attachment difficulties following 3 months of SMHC at the KKFC and if parents
have a history of neglect (with or without trauma).

Exclusion criteria:

- Children with cardiac arrhythmias, endocrine disorders associated with heart rate
irregularities or who are not able to cooperate or understand study procedures will be
excluded.

- Non-English speaking children or hearing impaired will be excluded.

- Children in foster care.