Efficacy of Group Attachment Based Intervention for Vulnerable Families
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ClinicalTrials.gov Identifier: NCT01641744 |
Recruitment Status
:
Recruiting
First Posted
: July 17, 2012
Last Update Posted
: July 15, 2016
|
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 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 |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | May 2017 |
Estimated Study Completion Date : | May 2017 |

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
|
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | up to 36 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Anne Murphy, PhD | 7184304107 | anne.murphy@einstein.yu.edu | |
Contact: Jordan Bate, MA | 9785024741 | jordan.bate@gmail.com |
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 |
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 of Yeshiva University |
ClinicalTrials.gov Identifier: | NCT01641744 History of Changes |
Other Study ID Numbers: |
2005-703 |
First Posted: | July 17, 2012 Key Record Dates |
Last Update Posted: | July 15, 2016 |
Last Verified: | July 2016 |
Keywords provided by Karen Bonuck, Albert Einstein College of Medicine of Yeshiva University:
Parent Child Relationship Maltreatment Risk Behaviors |
Social and Emotional Development Violence and Abuse Policy |