Efficacy of Group Attachment Based Intervention for Vulnerable Families
Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention
1 other identifier
interventional
146
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJune 28, 2018
June 1, 2018
5.3 years
July 12, 2012
June 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-up
Secondary Outcomes (6)
Child cognitive development (Bayley III Screening Test)
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)
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)
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)
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)
Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up
- +1 more secondary outcomes
Study Arms (2)
Group Attachment Based Intervention (GABI)
EXPERIMENTALSystematic Training for Effective Parenting (STEP)
ACTIVE COMPARATORInterventions
Parenting skills training class, 1x/week, 12 weeks
Parent-child group, 3x/week, 26 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Albert Einstein College of Medicinelead
- The New Schoolcollaborator
- Health Resources and Services Administration (HRSA)collaborator
Study Sites (1)
Center for Babies, Toddlers and Families, division of The Early Childhood Center
The Bronx, New York, 10461, United States
Related Publications (1)
Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
PMID: 37146219DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Bonuck, PhD
Albert Einstein College of Medicine
- PRINCIPAL INVESTIGATOR
Anne Murphy, PhD
Albert Einstein College of Medicine
- STUDY DIRECTOR
Miriam Steele, PhD
The New School
- STUDY DIRECTOR
Howard Steele, PhD
The New School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Karen A. Bonuck, PhD (Professor)
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 17, 2012
Study Start
August 1, 2012
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
June 28, 2018
Record last verified: 2018-06