FamilyLive Feasibility and Effectiveness Study

Anxiety Clinical Trial

Official title:

FamilyLive Feasibility and Effectiveness Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01524185
• Other study ID #: NA_00022038
• Status: Withdrawn
• Phase: Early Phase 1
• First received: January 30, 2012
• Last updated: April 6, 2018
• Start date: February 2009
• Est. completion date: January 8, 2016

Study information

• Verified date: April 2018
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 8, 2016
• Est. primary completion date: January 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Mood Lability
• PTSD

Intervention

Behavioral:
• FamilyLive
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

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Substance Abuse and Mental Health Services Administration (SAMHSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Examine the effects of FL on heart rate variability, behavior, post traumatic stress disorder symptoms, and functioning		4 years