Efficacy of Group Attachment Based Intervention for Vulnerable Families

Domestic Violence Clinical Trial

Official title:

Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641744
• Other study ID #: 2005-703
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: November 2017

Study information

• Verified date: June 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Maltreatment
• Domestic Violence

Intervention

Behavioral:
• Systematic Training for Effective Parenting (STEP)
Parenting skills training class, 1x/week, 12 weeks
• Group Attachment Based Intervention (GABI)
Parent-child group, 3x/week, 26 weeks

Locations

Country	Name	City	State
United States	Center for Babies, Toddlers and Families, division of The Early Childhood Center	Bronx	New York

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	Health Resources and Services Administration (HRSA), The New School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Child-parent attachment (Strange Situation Procedure) and Free -Play Observation coded with Coding Interactive Behavior (CIB) dimensions		Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up