Clinical trial NCT01641744: Efficacy of Group Attachment Based Intervention for Vulnerable Families
Official title: Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Maltreatment
Domestic Violence
Keywords: Parent Child Relationship
Maltreatment
Risk Behaviors
Social and Emotional Development
Violence and Abuse
Policy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: The New School
name: Health Resources and Services Administration (HRSA)
First posted: 2012-07-17
Enrollment: 146
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-up
Secondary outcomes:
measure: Child cognitive development (Bayley III Screening Test)
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up
measure: Parent mental health (Symptoms Checklist-90)
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up
measure: Child social-emotional development (Ages and Stages Questionnaire)
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up
measure: Parent social support (Interpersonal Support Evaluation List)
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up
measure: Parenting stress (Parenting Stress Index)
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-Up
measure: Child-parent attachment (Strange Situation Procedure) and Free -Play Observation coded with Coding Interactive Behavior (CIB) dimensions
timeFrame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Center for Babies, Toddlers and Families, division of The Early Childhood Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Karen Bonuck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Anne Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The New School
name: Miriam Steele, PhD
role: STUDY_DIRECTOR
affiliation: The New School
name: Howard Steele, PhD
role: STUDY_DIRECTOR
References: