Project BELONG: Breaking the Cycle of Intergenerational Family Violence and Trauma

NCT03212339 | Withdrawn

• 2 other identifiers: H-3577890EV0450-01-00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Parent-child interaction

  Parent-child interactions will be assessed from the 10-minute video recordings of naturalistic interaction between parent and child using the Coding Interactive Behavior (CIB) global rating system. The CIB assesses parent, child and dyadic affective states and interactive styles to measure social behavior. It includes multiple scales (ranging from 34 to 52 depending on age) organized into several composites that index important aspects of any relationship, such as sensitivity, intrusiveness, engagement, reciprocity.

  Change from baseline and 14 weeks

Secondary Outcomes (10)

• Parental concern of child development

  week 1

• Parenting stress

  Change from baseline and 14 weeks

• Parenting satisfaction and efficacy

  Change from baseline and 14 weeks

• Parental distress and depression

  Change from baseline and 14 weeks

• Parental reflective functioning

  Change from baseline and 14 weeks

Study Arms (2)

Mothers with children <3 years of age

EXPERIMENTAL

Dyads of mothers with children up to 3 years of age 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. Dyads will be offered the 10 session therapeutic intervention.

Other: Therapeutic intervention

Mothers with children 3-5 years of age

EXPERIMENTAL

Dyads of 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. Dyads will be offered the 10 session therapeutic intervention.

Other: Therapeutic intervention

Interventions

Therapeutic intervention OTHER

Therapeutic interventions will be delivered in ten 2-hour sessions over 12-15 weeks, which includes 2 research data collection sessions at the beginning of the study (pre-intervention) and at the end of the study (post-intervention). During the pre-intervention data collection session, participants will be asked to provide demographic information and complete interviews about their 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 post-intervention data collection session, participants will be asked to complete a similar set of interviews and will also be video recorded interacting with their child for 10 minutes.

Mothers with children 3-5 years of age; Mothers with children <3 years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female gender
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• The New School for Social Research: collaborator
• Children's Bureau - Administration for Children and Families: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Neena McConnico, PhD, LMHC

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Child Witness to Violence Project

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: July 11, 2017
• Study Start: February 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)