Child AbuseNCT00586677
Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment
A study testing Parent-Child Interaction Therapy, Health and Safety and Early Relationships in people with Child Abuse, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Abuse
- What is being tested?
- Parent-Child Interaction Therapy, Health and Safety and Early Relationships
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- resident of Durham, NC
- a child between the ages of 0-7 was the focus of the Department of Social Services report
- child's caregiver was the focus of the report
- Child Protective Services report occurred on or after June 1, 2004
- family is English speaking
- Sexual abuse was not "confirmed" or "highly suspicious" during an evaluation
Who cannot join
- Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious"
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Child and Family Health
Durham, North Carolina, 27701
About this study
Official title: Evaluation of Parenting Interventions to Decrease Family Risk for Child
The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship. We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.
- Conditions
- Child Abuse
- Being tested
- Parent-Child Interaction Therapy, Health and Safety, Early Relationships
- Keywords
- child abuse, child neglect, PCIT, Lutzker, attachment, parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction TherapyBehavioural
Also called PCIT
Sixteen one hour sessions done in-home for children ages 2-7. Proceed through protocol based on mastery of predefined skills.
Health and SafetyBehavioural
Sixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery.
Early RelationshipsBehavioural
Sixteen one-hour sessions for children age 0-2 provided in-home.
| Study group | Role | What they receive |
|---|---|---|
| RF | Active comparator | Relationship focused where the primary goals are to strengthen the relationship between the parent and the child and to give the parent additional skills that can be used to manage the behavior of the child. Receives: Behavioral: Parent-Child Interaction Therapy; Behavioral: Early Relationships |
| HS | Active comparator | The physical health and safety are the primary components of this parenting program where the parent is taught about basic healthcare and safety in the home. Receives: Behavioral: Health and Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durham County, North Carolina Department of Social Services accepted reports of child maltreatment
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionDec 2011
- Study completionDec 2011
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.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment
- Responsible party
- Sponsor
- Investigators
- Kenneth Dodge, Ph.D., Principal investigator, Duke UniversityKaren O'Donnell, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586677
- Sponsor's protocol ID
- Pro00016431
- Other IDs
- 7194
- Status last verified
- Sep 2014
- First submitted
- 21 Dec 2007
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Parenting Interventions to Decrease Family Risk for Child
- ClinicalTrials.gov ID
- NCT00586677
- Acronym / sponsor ID
- Pro00016431
- Conditions
- Child Abuse
- Keywords
- child abuse, child neglect, PCIT, Lutzker, attachment, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Duke Endowment
- Study start
- May 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jan 2008 (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 research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship. We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF | Active comparator | Behavioral: Parent-Child Interaction Therapy, Behavioral: Early RelationshipsRelationship focused where the primary goals are to strengthen the relationship between the parent and the child and to give the parent additional skills that can be used to manage the behavior of the child. |
| HS | Active comparator | Behavioral: Health and SafetyThe physical health and safety are the primary components of this parenting program where the parent is taught about basic healthcare and safety in the home. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- resident of Durham, NC
- a child between the ages of 0-7 was the focus of the Department of Social Services report
- child's caregiver was the focus of the report
- Child Protective Services report occurred on or after June 1, 2004
- family is English speaking
Key exclusion criteria (1 listed)
- Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious"
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 |
|---|---|---|
| Parent-Child Interaction TherapyAlso: PCITSixteen one hour sessions done in-home for children ages 2-7. Proceed through protocol based on mastery of predefined skills. | Behavioural | RF |
| Health and SafetySixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery. | Behavioural | HS |
| Early RelationshipsSixteen one-hour sessions for children age 0-2 provided in-home. | Behavioural | RF |
Primary outcome
Durham County, North Carolina Department of Social Services accepted reports of child maltreatment
Time frame: 2011
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 22 Sep 2014.
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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.
Kenneth Dodge, Ph.D. principal investigator
Duke University
Karen O'Donnell, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Interaction Therapy, Health and Safety and Early Relationships in people with Child Abuse, run by Duke University 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 1 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 22 Sep 2014. 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?
Durham County, North Carolina Department of Social Services accepted reports of child maltreatment (time frame: 2011). It is what the study was designed to measure, not a finding.
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 22 Sep 2014; AzTrials last refreshed its copy on 27 Oct 2026.