Child AbusePhase 3NCT00000382
Preventing Child Abuse in Infants
A Phase 3 study testing Infant-Parent Psychotherapy, Child Protective Services and Psychoeducational Home Visitation in people with Child Abuse, run by University of Rochester.
Trial summary
The purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison group. Read more about this study
- Who is it for?
- Ages 12 to 12 months
- Conditions the study is for
- Child Abuse
- What is being tested?
- Infant-Parent Psychotherapy, Child Protective Services and Psychoeducational Home Visitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1998to Jun 2003
- Phase
- Phase 3
- 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 12 to 12 months
- All sexes
- Child
Who may be able to join
- -
- Participants must have:
- Infants that have been maltreated by their biological caregiver during their first year of life and who continue to reside with their maternal caregiver. (Non-maltreated infants and their mothers will also be enrolled.)
Who cannot join
None listed.
About this study
Official title: Preventive Intervention for Maltreated Infants
The purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison group.
Twelve-month-old infants and their mothers are assigned randomly (like tossing a coin) to receive 1 of 3 types of intervention for 12 months: 1) Services normally available in the community when a family is reported for child maltreatment (Child Protective Services, CPS); 2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention will be provided until the infant's second birthday. All mother-infant pairs (including comparison non-maltreated infants and their mothers) will be assessed when the infant is 12, 18, 24, 36, and 48 months old. Assessments will look at the effectiveness of the intervention in preventing child maltreatment, improving parenting, and reducing future abuse. The study will last for 3 years.
Eligibility includes a mother and her 12-month-old child that has been abused by her (the mother) or the father. (Non-maltreated infants and their mothers also will be enrolled.)
Read the detailed description
To evaluate the relative effectiveness of 2 theoretically-informed approaches to preventing the adverse sequelae of maltreatment in infants: Psychoeducational Home Visitation (PHV) and Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers serve as a comparison.
Maltreated infants and their mothers are randomly assigned to 1 of 3 types of intervention for 12 months: 1) Services routinely available in the community when a family is reported for child maltreatment (Child Protective Services, CPS); 2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention is provided until the infant's second birthday. All mother-infant dyads (including comparison non-maltreated infants and their mothers) participate in baseline assessments at the infant's age of 12 months. Subsequent assessments occur at 18, 24, 36, and 48 months of age. Assessments measure three major areas: 1) family-ecological variables; 2) maternal functioning and parenting; and 3) child functioning and stage-salient issues. CPS records are monitored annually across all groups to determine whether any reports of maltreatment have been filed.
- Conditions
- Child Abuse
- Being tested
- Infant-Parent Psychotherapy, Child Protective Services, Psychoeducational Home Visitation, Parent Education
- Keywords
- Child Abuse, Female, Human, Infant, Male, Caregivers, Patient Education, Psychotherapy, Child Abuse -- *prevention & control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant-Parent PsychotherapyBehavioural
Child Protective ServicesBehavioural
Psychoeducational Home VisitationBehavioural
Parent EducationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study startJul 1998
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Dante Cicchetti, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000382
- Sponsor's protocol ID
- R01MH054643
- Other IDs
- R01MH054643, DSIR CT-P
- Status last verified
- Nov 2013
- First submitted
- 2 Nov 1999
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Intervention for Maltreated Infants
- ClinicalTrials.gov ID
- NCT00000382
- Acronym / sponsor ID
- R01MH054643
- Conditions
- Child Abuse
- Keywords
- Child Abuse, Female, Human, Infant, Male, Caregivers, Patient Education, Psychotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 1998
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 3 Nov 1999 (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 purpose of this study is to compare 2 approaches (interventions) to prevent child-abuse (maltreatment) in infants: Psychoeducational Home Visitation (PHV) vs Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers are studied as a comparison group.
Twelve-month-old infants and their mothers are assigned randomly (like tossing a coin) to receive 1 of 3 types of intervention for 12 months: 1) Services normally available in the community when a family is reported for child maltreatment (Child Protective Services, CPS); 2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention will be provided until the infant's second birthday. All mother-infant pairs (including comparison non-maltreated infants and their mothers) will be assessed when the infant is 12, 18, 24, 36, and 48 months old. Assessments will look at the effectiveness of the intervention in preventing child maltreatment, improving parenting, and reducing future abuse. The study will last for 3 years.
Eligibility includes a mother and her 12-month-old child that has been abused by her (the mother) or the father. (Non-maltreated infants and their mothers also will be enrolled.)
Detailed description
To evaluate the relative effectiveness of 2 theoretically-informed approaches to preventing the adverse sequelae of maltreatment in infants: Psychoeducational Home Visitation (PHV) and Infant-Parent Psychotherapy (IPP). Non-maltreated infants and their mothers serve as a comparison.
Maltreated infants and their mothers are randomly assigned to 1 of 3 types of intervention for 12 months: 1) Services routinely available in the community when a family is reported for child maltreatment (Child Protective Services, CPS); 2) CPS involvement plus weekly PHV; 3) CPS involvement plus weekly IPP. Intervention is provided until the infant's second birthday. All mother-infant dyads (including comparison non-maltreated infants and their mothers) participate in baseline assessments at the infant's age of 12 months. Subsequent assessments occur at 18, 24, 36, and 48 months of age. Assessments measure three major areas: 1) family-ecological variables; 2) maternal functioning and parenting; and 3) child functioning and stage-salient issues. CPS records are monitored annually across all groups to determine whether any reports of maltreatment have been filed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- -
- Infants that have been maltreated by their biological caregiver during their first year of life and who continue to reside with their maternal caregiver. (Non-maltreated infants and their mothers will also be enrolled.)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Infant-Parent Psychotherapy | Behavioural | – |
| Child Protective Services | Behavioural | – |
| Psychoeducational Home Visitation | Behavioural | – |
| Parent Education | Behavioural | – |
Primary outcome
Not reported in the source record.
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 6 Nov 2013.
Related trials for Child Abuse
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
Not yet recruitingPhase 3
NTI164 in Autism Spectrum Disorder
Autism, Autism Spectrum Disorder
Enrolling by invitation
Identification With the Aggressor (IWA)
Female, Abuse Neglect
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.
Dante Cicchetti, PhD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infant-Parent Psychotherapy, Child Protective Services and Psychoeducational Home Visitation in people with Child Abuse, run by University of Rochester.
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 3 inclusion and 0 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 6 Nov 2013.