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Efficacy of Group Attachment Based Intervention for Vulnerable Families

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ClinicalTrials.gov Identifier: NCT01641744
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
The New School
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Karen Bonuck, Albert Einstein College of Medicine, Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Child Maltreatment Domestic Violence Behavioral: Systematic Training for Effective Parenting (STEP) Behavioral: Group Attachment Based Intervention (GABI) Not Applicable

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.

Seventy 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention
Actual Study Start Date : August 2012
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Child-parent attachment (Strange Situation Procedure) and Free -Play Observation coded with Coding Interactive Behavior (CIB) dimensions [ Time Frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up ]


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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641744


Locations
United States, New York
Center for Babies, Toddlers and Families, division of The Early Childhood Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
The New School
Health Resources and Services Administration (HRSA)
Investigators
Principal Investigator: Karen Bonuck, PhD Albert Einstein College of Medicine, Inc.
Principal Investigator: Anne Murphy, PhD Albert Einstein College of Medicine, Inc.
Study Director: Miriam Steele, PhD The New School
Study Director: Howard Steele, PhD The New School

Responsible Party: Karen Bonuck, Karen A. Bonuck, PhD (Professor), Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01641744     History of Changes
Other Study ID Numbers: 2005-703
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Keywords provided by Karen Bonuck, Albert Einstein College of Medicine, Inc.:
Parent Child Relationship
Maltreatment
Risk Behaviors
Social and Emotional Development
Violence and Abuse
Policy