FamilyLive Feasibility and Effectiveness Study

NCT ID: NCT01524185

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2016-01-08

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.

Detailed Description

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.

Conditions

Mood Lability; PTSD; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FamilyLive

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

Group Type: EXPERIMENTAL

FamilyLive

Intervention Type: BEHAVIORAL

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

Standard Mental Health Treatment

Standard trauma-informed mental health treatment

Group Type: ACTIVE_COMPARATOR

Standard Mental Health Treatment

Intervention Type: BEHAVIORAL

Standard trauma-informed mental health treatment

Interventions

FamilyLive

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

Intervention Type: BEHAVIORAL

Standard Mental Health Treatment

Standard trauma-informed mental health treatment

Intervention Type: BEHAVIORAL

Other Intervention Names

FL; SMHC

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Harolyn M.E.Belcher, M.D.

Director of Research, Family Center at Kennedy Krieger Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00022038

Identifier Type: -

Identifier Source: org_study_id