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

Primary Purpose

Mother-child Relations, Parenting, Parent Child Abuse

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic intervention
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mother-child Relations focused on measuring parent-child interactions, mental health care, child health services, parenting confidence, adverse childhood events, dyadic care model

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mothers with children <3 years of age

Mothers with children 3-5 years of age

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Parental concern of child development
Parental concern of child development will be assessed via the 10-item Parent's Evaluation of Developmental Status (PEDS). The PEDS is an evidence-based method for detecting and addressing developmental and behavioral problems in children aged from birth to eight years. All responses are based on the age of the child and scoring sorts children into high, moderate or low risk for an undiagnosed developmental disability and behavioral problems requiring referral for in-depth evaluation.
Parenting stress
Parenting stress will be assessed via the 36-item Parenting Stress Index (PSI) Short Form. The PSI is a screening and triage measure for evaluating the parenting system and identifying issues in parental functioning that may lead to problems in the child's behavior. Designed for use with parents of children ranging in age from 1 month to 12 years, the PSI yields a total stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, using a 5-point scale ranging from strongly agree [1] to strongly disagree [5]. Scores are calculated for each sub-scales and then added to yield the Total Stress score. Altogether, the higher the score, the greater the level of stress in parents.
Parenting satisfaction and efficacy
Parenting satisfaction and efficacy will be assessed via the 17-item Parenting Sense of Competence Scale (PSOC). The PSOC was designed to measure parental competence on two dimensions: satisfaction and efficacy, using a 6-point scale ranging from strongly agree [1] to strongly disagree [6], with ten questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Scores are calculated by adding all responses to yield the participants PSOC score. A higher score indicates a higher parenting sense of competency; there are no average scores or 'cut-off's' for this tool.
Parental distress and depression
Parental psychological distress, interpersonal sensitivity, and depression will be assessed via the 53-item Brief Symptom Inventory (BSI). The BSI was designed to evaluate psychological distress in the past week using a 4-point scale ranging from not at all [0] to extreme [4]. It is composed of nine primary symptom dimensions (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism) and includes three global indices of distress (Global Severity, Positive Symptom Distress, and Positive Symptom Total) to measure the overall distress level, intensity of symptoms, and number of self-reported symptoms. A clinically significant score can be reached in two ways: the GSI score is greater than or equal to a T score of 63, or any two subscales are greater than or equal to a T score of 63 when compared with the norms for the particular population in question.
Parental reflective functioning
Parental mentalization and reflective functioning will be assessed via the 18-item Parental Reflective Functioning Questionnaire (PRFQ). The PRFQ was designed for parents of children 0-5 years to provide a brief, multidimensional assessment of parental reflective functioning and mentalization, which refers to the caregiver's capacity to reflect upon her own internal mental experiences as well as those of the child. Parental reflective functioning is assumed to play a key role in fostering the developing child's own capacity for mentalizing, which in turn is important for the development of emotion regulation, a sense of personal agency, and secure attachment relationships. Items were formulated positively (i.e., higher scores reflect higher levels of parental reflective functioning) and negatively (i.e, higher scores reflect lower levels of mentalization).
Parental perceptions of infant/child development
Parental perceptions of their infant/child development will be assessed via 6 questions adapted from the Working Model of the Child Interview (WMCI). The WMCI is a semi-structured, open-ended interview designed to assess parent's perception of and relationship with their infant/child. The questions adapted from the WMCI include: 1) "What are three things you feel are unique and different about your child compared to (what you know of) children?" 2) "What are three things that pleases you the most about your relationship with your child/baby?" 3) "Think for a moment of your child as an adult. What five hopes and fears do you have about that time?" 4) Pick 5 words to describe your impression of your child's personality now. 5) At this point, who does your child remind you of? In what ways? 6) Pick 5 words to describe your relationship with your child now. There is no score or 'cut-off' for this tool.
Parental childhood experiences of abuse and neglect
Parental childhood experiences of abuse and neglect will be assessed via the 26-item Clinical Adverse Childhood Experience Questionnaire. The Clinical ACEs was adapted from the original ACEs Questionnaire and includes ten categories of childhood adversity: exposure to psychological, physical and sexual abuse, emotional and physical neglect, household dysfunction including parental divorce or separation, untreated parental mental illness, parental alcohol or substance abuse, parental incarceration, and exposure to mother treated violently. Scores are calculated by adding all responses to yield the participants PSOC score. A higher score indicates a higher risk of health and social problems; there are no average scores or 'cut-off's' for this tool.
Child social and emotional skills and competencies
Child social and emotional skills and competencies will be assessed via the age-appropriate Devereux Early Childhood Assessment (DECA). The DECA is a standardized, strength based assessment to assess protective factors and screening for potential risks in the social and emotional development of very young children. The DECA Infant (4 weeks up to 18 months) has 33 items and comprises of two protective factor scales: Initiative and Attachment/Relationships. The DECA Toddler (age 18 months to 36 months) has 36 items and comprises of three protective factor scales: Initiative, Attachment/Relationships, and Self-Regulation. The DECA for Preschoolers (ages 3 to 6 years) has 38 items and comprises of four protective factor scales: Total protective Factors, Initiative, Self-Regulation, and Attachment/Relationships. Scores correspond to the child's age and rater, and are calculated by adding all responses in each scale. Scores place children in three categories: typical, strength, and concern.
Interviewer-observed parent-child interaction
In addition to the 10-minute video recordings of naturalistic interaction between parent and child, parent-child interaction will be assessed via the interviewer-observed 8-item Home Observation Measurement of the Environment (HOME). The HOME was designed to measure the quality and quantity of stimulation and support available to a child in the home environment. There is no score or 'cut-off' for this tool.
Material hardships
Food insecurity will be assessed via two standardized questions developed by the US Dept of Agriculture Economic Research: Guide to Measuring Household Food Security. These include "within the past 6 months…": 1) "…we worried whether our food would run out before we got money to buy more" and 2) "…the food we bought just didn't last and we didn't have money to get more." Housing instability will be assessed in accordance with previously published measures, as no official US measure exists. These include: 1) "What kind of housing do you currently live in?" 2) "Are you temporarily living with other people even for a little while because of financial difficulties?" 3) "Can you continue to stay where you are for as long as you want?" 4) "When was the last time if ever that you considered yourself to be without a regular place to stay or homeless?" and 5) "During the past 6 months, was there a time when you were not able to pay the mortgage/rent on time because of financial difficulties?"

Full Information

First Posted
May 30, 2017
Last Updated
August 1, 2019
Sponsor
Boston Medical Center
Collaborators
The New School for Social Research, Children's Bureau - Administration for Children and Families
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1. Study Identification

Unique Protocol Identification Number
NCT03212339
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was halted due to challenges with recruitment and enrollment.
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
Collaborators
The New School for Social Research, Children's Bureau - Administration for Children and Families

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mothers with children <3 years of age
Arm Type
Experimental
Arm Description
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.
Arm Title
Mothers with children 3-5 years of age
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent-child interaction
Description
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.
Time Frame
Change from baseline and 14 weeks
Secondary Outcome Measure Information:
Title
Parental concern of child development
Description
Parental concern of child development will be assessed via the 10-item Parent's Evaluation of Developmental Status (PEDS). The PEDS is an evidence-based method for detecting and addressing developmental and behavioral problems in children aged from birth to eight years. All responses are based on the age of the child and scoring sorts children into high, moderate or low risk for an undiagnosed developmental disability and behavioral problems requiring referral for in-depth evaluation.
Time Frame
week 1
Title
Parenting stress
Description
Parenting stress will be assessed via the 36-item Parenting Stress Index (PSI) Short Form. The PSI is a screening and triage measure for evaluating the parenting system and identifying issues in parental functioning that may lead to problems in the child's behavior. Designed for use with parents of children ranging in age from 1 month to 12 years, the PSI yields a total stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, using a 5-point scale ranging from strongly agree [1] to strongly disagree [5]. Scores are calculated for each sub-scales and then added to yield the Total Stress score. Altogether, the higher the score, the greater the level of stress in parents.
Time Frame
Change from baseline and 14 weeks
Title
Parenting satisfaction and efficacy
Description
Parenting satisfaction and efficacy will be assessed via the 17-item Parenting Sense of Competence Scale (PSOC). The PSOC was designed to measure parental competence on two dimensions: satisfaction and efficacy, using a 6-point scale ranging from strongly agree [1] to strongly disagree [6], with ten questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Scores are calculated by adding all responses to yield the participants PSOC score. A higher score indicates a higher parenting sense of competency; there are no average scores or 'cut-off's' for this tool.
Time Frame
Change from baseline and 14 weeks
Title
Parental distress and depression
Description
Parental psychological distress, interpersonal sensitivity, and depression will be assessed via the 53-item Brief Symptom Inventory (BSI). The BSI was designed to evaluate psychological distress in the past week using a 4-point scale ranging from not at all [0] to extreme [4]. It is composed of nine primary symptom dimensions (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism) and includes three global indices of distress (Global Severity, Positive Symptom Distress, and Positive Symptom Total) to measure the overall distress level, intensity of symptoms, and number of self-reported symptoms. A clinically significant score can be reached in two ways: the GSI score is greater than or equal to a T score of 63, or any two subscales are greater than or equal to a T score of 63 when compared with the norms for the particular population in question.
Time Frame
Change from baseline and 14 weeks
Title
Parental reflective functioning
Description
Parental mentalization and reflective functioning will be assessed via the 18-item Parental Reflective Functioning Questionnaire (PRFQ). The PRFQ was designed for parents of children 0-5 years to provide a brief, multidimensional assessment of parental reflective functioning and mentalization, which refers to the caregiver's capacity to reflect upon her own internal mental experiences as well as those of the child. Parental reflective functioning is assumed to play a key role in fostering the developing child's own capacity for mentalizing, which in turn is important for the development of emotion regulation, a sense of personal agency, and secure attachment relationships. Items were formulated positively (i.e., higher scores reflect higher levels of parental reflective functioning) and negatively (i.e, higher scores reflect lower levels of mentalization).
Time Frame
Change from baseline and 14 weeks
Title
Parental perceptions of infant/child development
Description
Parental perceptions of their infant/child development will be assessed via 6 questions adapted from the Working Model of the Child Interview (WMCI). The WMCI is a semi-structured, open-ended interview designed to assess parent's perception of and relationship with their infant/child. The questions adapted from the WMCI include: 1) "What are three things you feel are unique and different about your child compared to (what you know of) children?" 2) "What are three things that pleases you the most about your relationship with your child/baby?" 3) "Think for a moment of your child as an adult. What five hopes and fears do you have about that time?" 4) Pick 5 words to describe your impression of your child's personality now. 5) At this point, who does your child remind you of? In what ways? 6) Pick 5 words to describe your relationship with your child now. There is no score or 'cut-off' for this tool.
Time Frame
Change from baseline and 14 weeks
Title
Parental childhood experiences of abuse and neglect
Description
Parental childhood experiences of abuse and neglect will be assessed via the 26-item Clinical Adverse Childhood Experience Questionnaire. The Clinical ACEs was adapted from the original ACEs Questionnaire and includes ten categories of childhood adversity: exposure to psychological, physical and sexual abuse, emotional and physical neglect, household dysfunction including parental divorce or separation, untreated parental mental illness, parental alcohol or substance abuse, parental incarceration, and exposure to mother treated violently. Scores are calculated by adding all responses to yield the participants PSOC score. A higher score indicates a higher risk of health and social problems; there are no average scores or 'cut-off's' for this tool.
Time Frame
week 1
Title
Child social and emotional skills and competencies
Description
Child social and emotional skills and competencies will be assessed via the age-appropriate Devereux Early Childhood Assessment (DECA). The DECA is a standardized, strength based assessment to assess protective factors and screening for potential risks in the social and emotional development of very young children. The DECA Infant (4 weeks up to 18 months) has 33 items and comprises of two protective factor scales: Initiative and Attachment/Relationships. The DECA Toddler (age 18 months to 36 months) has 36 items and comprises of three protective factor scales: Initiative, Attachment/Relationships, and Self-Regulation. The DECA for Preschoolers (ages 3 to 6 years) has 38 items and comprises of four protective factor scales: Total protective Factors, Initiative, Self-Regulation, and Attachment/Relationships. Scores correspond to the child's age and rater, and are calculated by adding all responses in each scale. Scores place children in three categories: typical, strength, and concern.
Time Frame
Change from baseline and 14 weeks
Title
Interviewer-observed parent-child interaction
Description
In addition to the 10-minute video recordings of naturalistic interaction between parent and child, parent-child interaction will be assessed via the interviewer-observed 8-item Home Observation Measurement of the Environment (HOME). The HOME was designed to measure the quality and quantity of stimulation and support available to a child in the home environment. There is no score or 'cut-off' for this tool.
Time Frame
Change from baseline and 14 weeks
Title
Material hardships
Description
Food insecurity will be assessed via two standardized questions developed by the US Dept of Agriculture Economic Research: Guide to Measuring Household Food Security. These include "within the past 6 months…": 1) "…we worried whether our food would run out before we got money to buy more" and 2) "…the food we bought just didn't last and we didn't have money to get more." Housing instability will be assessed in accordance with previously published measures, as no official US measure exists. These include: 1) "What kind of housing do you currently live in?" 2) "Are you temporarily living with other people even for a little while because of financial difficulties?" 3) "Can you continue to stay where you are for as long as you want?" 4) "When was the last time if ever that you considered yourself to be without a regular place to stay or homeless?" and 5) "During the past 6 months, was there a time when you were not able to pay the mortgage/rent on time because of financial difficulties?"
Time Frame
Change from baseline and 14 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neena McConnico, PhD, LMHC
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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