Child MaltreatmentNCT01641744
Efficacy of Group Attachment Based Intervention for Vulnerable Families
A study testing Systematic Training for Effective Parenting (STEP) and Group Attachment Based Intervention (GABI) in people with Child Maltreatment and Domestic Violence, run by Albert Einstein College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Domestic Violence
- What is being tested?
- Systematic Training for Effective Parenting (STEP) and Group Attachment Based Intervention (GABI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Babies, Toddlers and Families, division of The Early Childhood Center
The Bronx, New York, 10461
About this study
Official title: Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention
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.
Read the 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.
- Conditions
- Child Maltreatment, Domestic Violence
- Being tested
- Systematic Training for Effective Parenting (STEP), Group Attachment Based Intervention (GABI)
- Keywords
- Parent Child Relationship, Maltreatment, Risk Behaviors, Social and Emotional Development, Violence and Abuse, Policy
- Medical subject headings
- Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic Training for Effective Parenting (STEP)Behavioural
Parenting skills training class, 1x/week, 12 weeks
Group Attachment Based Intervention (GABI)Behavioural
Parent-child group, 3x/week, 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group Attachment Based Intervention (GABI) | Experimental | Not described Receives: Behavioral: Group Attachment Based Intervention (GABI) |
| Systematic Training for Effective Parenting (STEP) | Active comparator | Not described Receives: Behavioral: Systematic Training for Effective Parenting (STEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: 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: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention, and at 6-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The New School, Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Karen Bonuck, Albert Einstein College of Medicine
- Investigators
- Karen Bonuck, PhD, Principal investigator, Albert Einstein College of MedicineAnne Murphy, PhD, Principal investigator, Albert Einstein College of MedicineMiriam Steele, PhD, Study director, The New SchoolHoward Steele, PhD, Study director, The New School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641744
- Sponsor's protocol ID
- 2005-703
- Status last verified
- Jun 2018
- First submitted
- 12 Jul 2012
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37146219
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth to Three: A Pragmatic Clinical Trial for Child Maltreatment Prevention
- ClinicalTrials.gov ID
- NCT01641744
- Acronym / sponsor ID
- 2005-703
- Conditions
- Child Maltreatment, Domestic Violence
- Keywords
- Parent Child Relationship, Maltreatment, Risk Behaviors, Social and Emotional Development, Violence and Abuse, Policy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- The New School, Health Resources and Services Administration (HRSA)
- Study start
- Aug 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic Training for Effective Parenting (STEP)Parenting skills training class, 1x/week, 12 weeks | Behavioural | Systematic Training for Effective Parenting (STEP) |
| Group Attachment Based Intervention (GABI)Parent-child group, 3x/week, 26 weeks | Behavioural | Group Attachment Based Intervention (GABI) |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Derived from this study: PubMed 37146219Jones 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Bonuck, PhD principal investigator
Albert Einstein College of Medicine
Anne Murphy, PhD principal investigator
Albert Einstein College of Medicine
Miriam Steele, PhD study director
The New School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic Training for Effective Parenting (STEP) and Group Attachment Based Intervention (GABI) in people with Child Maltreatment and Domestic Violence, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Measured at Baseline, End-of-Treatment (12 Weeks for Control/26 Weeks for Intervention), and at 6-Month Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01641744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.