Clinical trial NCT03212339: Project BELONG: Breaking the Cycle of Intergenerational Family Violence and Trauma
Official title: Project BELONG: Breaking the Cycle of Intergenerational Family Violence and Trauma: Innovating, Expanding and Sustaining Treatment for Caregivers and Very Young Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mother-child Relations
Parenting
Parent Child Abuse
Family Conflict
Parental Stress
Family Relations
Childhood Disorder of Social Functioning, Unspecified
Keywords: parent-child interactions
mental health care
child health services
parenting confidence
adverse childhood events
dyadic care model
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: The New School for Social Research
name: Children's Bureau - Administration for Children and Families
First posted: 2017-07-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine the efficacy of a dyadic therapy intervention for mothers who have histories of adverse events (e.g., history of family violence, partner violence, family conflict, and/or childhood trauma, including abuse/neglect) and their very young children (ages 0-5 years), with the goal of demonstrating how an evidence supported, community-based and/or hospital-based therapeutic intervention may help reduce exposure to trauma and incidents of child maltreatment, improve parental stress and mental health, and secure parent-child attachment.

The three main objectives associated with Project BELONG are: 1) to determine the effectiveness of a dyadic care model in improving parent/child interaction, parenting confidence and competence, reducing parenting stress and social isolation, and improving access to concrete supports; 2) to address maltreatment risk in children by enhancing social-emotional functioning and developmental progress; and 3) to train new and future mental health professionals in dyadic mental health services and disseminate the model and findings through health professional schools and publications.

Detailed description: A maximum of ninety (N=90) women and children will be screened and recruited from three clinical care programs at Boston Medical Center (BMC): 1) the SPARK Center, 2) Child Witness to Violence, and 3) Project RESPECT, to participate in therapeutic programming delivered by trained psychologists, social workers and therapists at the SPARK Center in Mattapan, MA or at Child Witness to Violence at BMC in Boston, MA. Mothers with children through the age of 3 years will be attending modified Group Attachment Based Intervention (mGABI) sessions at the SPARK Center that will include a small group of other mother-child pairs and approximately two therapists. Mothers with children between the ages of 3 and 5 years will be attending Brief Dyadic Intervention (BDI) sessions at Child Witness to Violence and/or the SPARK Center with their child and an individual therapist. The therapeutic interventions will be similar between the two groups and will be delivered in 10 sessions over the course of approximately 12-15 weeks. Each session will be approximately 2 hours long and will be scheduled to accommodate the participants' schedules. Participants will be asked to attend 1 session per week and to participate in two research data collection sessions that are part of the 10-session commitment. The first session will occur at the beginning of the study (pre-intervention) and the second session will occur at the end of the study (post-intervention). During the first data collection session, participants will be asked to provide demographic information and complete interviews about past experiences and current experiences as a parent, and their child's current functioning. Parents will also be video recorded interacting with their child for 10 minutes. During the second data collection session, participants will be asked to complete a similar set of interviews and they will be video recorded again interacting with their child for 10 minutes.

Project BELONG will address the impact of trauma and dyadic therapy on the mother and child as it affects parenting, child development, and child behavior. Changes in parents' ability to interact with their child in nurturing and responsive ways (as measured by coding videotapes of pre- and post- mother-child interactions) will be investigated as well as improvements in maternal symptoms of stress, depression and feelings of self-efficacy (as measured by validated, evidence-based pre- and post- assessments). Child outcomes will be assessed via change from baseline in measures of child's psychosocial functioning and development.

Eligibility criteria: Inclusion Criteria:

* Female gender
* 18 years of age or older
* Has a child under the age of 5 years
* Must be parent or legal guardian of child
* Comfortable communicating in English
* Plan to stay in the greater Boston area for the next 6 months \[post IRB-approval\]
* Typically available between the hours of 8:00 AM and 5:00 PM at least one day during the week (Monday thru Friday)
* Must answer "yes" to having experienced hardships in their own life, which may have involved any of the following: threat of violence, family violence, partner violence, family conflict, and/or mistreatment in their own childhood.
* Must be able to provide informed consent

Exclusion Criteria:

* Child previously diagnosed with autism, severe global delay, blindness, deafness or paralysis

Primary outcomes:
measure: Parent-child interaction
timeFrame: Change from baseline and 14 weeks
Secondary outcomes:
measure: Parental concern of child development
timeFrame: week 1
measure: Parenting stress
timeFrame: Change from baseline and 14 weeks
measure: Parenting satisfaction and efficacy
timeFrame: Change from baseline and 14 weeks
measure: Parental distress and depression
timeFrame: Change from baseline and 14 weeks
measure: Parental reflective functioning
timeFrame: Change from baseline and 14 weeks
measure: Parental perceptions of infant/child development
timeFrame: Change from baseline and 14 weeks
measure: Parental childhood experiences of abuse and neglect
timeFrame: week 1
measure: Child social and emotional skills and competencies
timeFrame: Change from baseline and 14 weeks
measure: Interviewer-observed parent-child interaction
timeFrame: Change from baseline and 14 weeks
measure: Material hardships
timeFrame: Change from baseline and 14 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Neena McConnico, PhD, LMHC
role: PRINCIPAL_INVESTIGATOR
References: