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Completed

NCT Number: NCT01641744

Efficacy of Group Attachment Based Intervention for Vulnerable Families

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.

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Key information

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic Training for Effective Parenting (STEP)

Behavioral

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

Group Attachment Based Intervention (GABI)

Behavioral

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

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)

    Time frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-up

Secondary outcomes

  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) and Free -Play Observation coded with Coding Interactive Behavior (CIB) dimensions

    Time frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Health Resources and Services Administration (HRSA)
  • The New School

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2012
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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