FamilyLive Feasibility and Effectiveness Study

NCT01524185 | Withdrawn Early Phase 1

• 1 other identifier: NA_00022038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

childhood trauma; intergenerational trauma; child neglect; child maltreatment; mental health

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (1)

• Examine the effects of FL on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning

  4 years

Study Arms (2)

FamilyLive

EXPERIMENTAL

Multi-therapist group intervention for families with a history of intergenerational neglect and trauma exposure

Behavioral: FamilyLive

Standard Mental Health Treatment

ACTIVE COMPARATOR

Standard trauma-informed mental health treatment

Behavioral: Standard Mental Health Treatment

Interventions

FamilyLive BEHAVIORAL

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

Also known as: FL

FamilyLive

Standard Mental Health Treatment BEHAVIORAL

Standard trauma-informed mental health treatment

Also known as: SMHC

Standard Mental Health Treatment

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Historical Trauma; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Psychological Trauma; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Family Center at Kennedy Krieger Institute

Study Record Dates

• First Submitted: January 30, 2012
• First Posted: February 1, 2012
• Study Start: February 1, 2009
• Primary Completion: January 8, 2016
• Study Completion: January 8, 2016
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)