Efficacy of Group Attachment Based Intervention for Vulnerable Families

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01641744

Collaborator

The New School (Other), Health Resources and Services Administration (HRSA) (U.S. Fed)

146

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

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.

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 Design

Study Type:

Interventional

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 :

Aug 1, 2012

Actual Primary Completion Date :

Nov 1, 2017

Actual Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

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

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 36 Months

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