Efficacy of Group Attachment Based Intervention for Vulnerable Families

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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/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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, 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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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