NCT01641744

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

5.3 years

First QC Date

July 12, 2012

Last Update Submit

June 26, 2018

Conditions

Keywords

Parent Child RelationshipMaltreatmentRisk BehaviorsSocial and Emotional DevelopmentViolence and AbusePolicy

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)

EXPERIMENTAL
Behavioral: Group Attachment Based Intervention (GABI)

Systematic Training for Effective Parenting (STEP)

ACTIVE COMPARATOR
Behavioral: Systematic Training for Effective Parenting (STEP)

Interventions

Parenting skills training class, 1x/week, 12 weeks

Systematic Training for Effective Parenting (STEP)

Parent-child group, 3x/week, 26 weeks

Group Attachment Based Intervention (GABI)

Eligibility Criteria

AgeUp to 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

Center for Babies, Toddlers and Families, division of The Early Childhood Center

The Bronx, New York, 10461, United States

Location

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.

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Karen Bonuck, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
  • Anne Murphy, PhD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR
  • Miriam Steele, PhD

    The New School

    STUDY DIRECTOR
  • Howard Steele, PhD

    The New School

    STUDY DIRECTOR

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

Locations