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FamilyLive Feasibility and Effectiveness Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Collaborator:
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Harolyn M.E.Belcher, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01524185
First received: January 30, 2012
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Mood Lability
PTSD
Anxiety
Behavioral: FamilyLive
Behavioral: Standard Mental Health Treatment
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FamilyLive Feasibility and Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine the effects of FL on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: February 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FamilyLive
Multi-therapist group intervention for families with a history of intergenerational neglect and trauma exposure
Behavioral: FamilyLive
Multi-therapist family mental health treatment for families with a history of intergenerational neglect and trauma
Other Name: FL
Active Comparator: Standard Mental Health Treatment
Standard trauma-informed mental health treatment
Behavioral: Standard Mental Health Treatment
Standard trauma-informed mental health treatment
Other Name: 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.

  Eligibility

Ages Eligible for Study:   5 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524185

Contacts
Contact: Harolyn ME Belcher, MD 443-923-5933 belcher@kennedykrieger.org

Locations
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21231
Contact: Harolyn ME Belcher, MD    443-923-5933    belcher@kennedykrieger.org   
Principal Investigator: Harolyn ME Belcher, MD         
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Substance Abuse and Mental Health Services Administration (SAMHSA)
  More Information

No publications provided

Responsible Party: Harolyn M.E.Belcher, M.D., Director of Research, Family Center at Kennedy Krieger Institute, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01524185     History of Changes
Other Study ID Numbers: NA_00022038
Study First Received: January 30, 2012
Last Updated: September 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
childhood trauma
intergenerational trauma
child neglect
child maltreatment
mental health

ClinicalTrials.gov processed this record on November 25, 2014