Efficacy of Group Attachment Based Intervention for Vulnerable Families

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborators:
The New School
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Karen Bonuck, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01641744
First received: July 12, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

The study examines the effectiveness of parent-child Group Attachment Based Intervention (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting skills classes. GABI directly addresses the needs of isolated, marginalized families, with the goals of of enhancing parent coping and resilience, and improving parent-child attachment relationships.

We hypothesize that compared to usual care, GABI will be associated with improved child, parent and parent-child outcomes.


Condition Intervention
Child Maltreatment
Domestic Violence
Behavioral: Systematic Training for Effective Parenting (STEP)
Behavioral: Group Attachment Based Intervention (GABI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Change from baseline in child exposure to trauma and maltreatment to end-of-treatment and at 6-month follow-up (Child Adverse Childhood Experiences Screener) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Child cognitive development (Bayley III Screening Test) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up ] [ Designated as safety issue: No ]
  • Parent mental health (Symptoms Checklist-90) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up ] [ Designated as safety issue: Yes ]
  • Child social-emotional development (Ages and Stages Questionnaire) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up ] [ Designated as safety issue: No ]
  • Parent social support (Interpersonal Support Evaluation List) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up ] [ Designated as safety issue: No ]
  • Parenting stress (Parenting Stress Index) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up ] [ Designated as safety issue: No ]
  • Child-parent attachment (Strange Situation Procedure/Parent-Infant Relationship Global Assessment) [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Attachment Based Intervention (GABI) Behavioral: Group Attachment Based Intervention (GABI)
Parent-child group, 3x/week, 26 weeks
Active Comparator: Systematic Training for Effective Parenting (STEP) Behavioral: Systematic Training for Effective Parenting (STEP)
Parenting skills training class, 1x/week, 12 weeks

Detailed Description:

Child abuse and neglect ("maltreatment") pose enormous short- and long-term risks to children. Yet despite the critical importance of the U.S. Department of Health and Human Services, Maternal and Child Health Bureau's goal "to reduce fatal and non-fatal child maltreatment," non-empirically supported parenting skills classes remain child welfare agencies' standard approach to meeting this goal.

The study examines the effectiveness of parent-child Group Attachment Based Intervention (GABI) in reducing risk of maltreatment in infants and toddlers compared with parenting skills classes. GABI directly addresses the needs of isolated, marginalized families, with the goals of of enhancing parent coping and resilience, and improving parent-child attachment relationships.

One hundred families with children aged 2-36 months who are referred for parenting help will be randomly assigned to either GABI or "treatment as usual" that consists of parents-only parenting skills classes. Treatment will be offered for up to 6 months. Both groups will be assessed at baseline, end of treatment and at 6 months follow up.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parents with children age 0-36 months
  • Parent(s) is/are biological parent of child (mother or father)
  • Parent(s) has/have custody of their child even if he/she/they have lost custody of previous children
  • Risk of maltreatment from referral source or intake interview, including parent's own childhood adversity, parent's current exposure to relationship violence, history of parental substance abuse or history of parental incarceration
  • If history of substance abuse, enrolled in treatment program
  • Willing to sign informed consent

Exclusion Criteria:

  • Parent is unable to provide informed consent due to cognitive impairment
  • Parent not fluent in English
  • Child has diagnosis of an autistic spectrum disorder or severe cognitive delay
  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: NCT01641744

Contacts
Contact: Anne Murphy, PhD 7184304107 anne.murphy@einstein.yu.edu
Contact: Jordan Bate, MA 9785024741 jordan.bate@gmail.com

Locations
United States, New York
Center for Babies, Toddlers and Families, division of The Early Childhood Center Recruiting
Bronx, New York, United States, 10461
Contact: Anne Murphy, PhD    718-430-4107    anne.murphy@einstein.yu.edu   
Principal Investigator: Anne Murphy, PhD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
The New School
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Karen Bonuck, PhD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Anne Murphy, PhD Albert Einstein College of Medicine of Yeshiva University
Study Director: Miriam Steele, PhD The New School
Study Director: Howard Steele, PhD The New School
  More Information

No publications provided

Responsible Party: Karen Bonuck, Karen A. Bonuck, PhD (Professor), Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01641744     History of Changes
Other Study ID Numbers: 2005-703
Study First Received: July 12, 2012
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Parent Child Relationship
Maltreatment
Risk Behaviors
Social and Emotional Development
Violence and Abuse
Policy

ClinicalTrials.gov processed this record on July 28, 2014