Child AbusePhase 1NCT00595010
Effectiveness of a Multi-Component Evidence-Based Parent Training Program in Reducing Child Maltreatment
A Phase 1 study testing SafeCare in people with Child Abuse, run by University of Oklahoma.
Trial summary
This study will determine the effectiveness of a complex parent training program, based on the SafeCare model, in reducing the occurrence of child maltreatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Abuse
- What is being tested?
- SafeCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 2012
- Phase
- Phase 1
- 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
- Enrolled in Oklahoma Comprehensive Home-Based Services (CHBS)
- Child referred by Office of Community Services
Who cannot join
- Primary referral of sexual abuse
- Primary referral goal to maintain permanent placement
About this study
Official title: Developing Multi-Component Evidence Based Practice in Child Abuse Service Systems
This study will determine the effectiveness of a complex parent training program, based on the SafeCare model, in reducing the occurrence of child maltreatment.
Read the detailed description
Child maltreatment is the general term used to characterize all forms of child abuse, including neglect and physical, sexual, and emotional abuse. These forms of maltreatment can lead to a large number of child developmental, emotional, and behavioral difficulties. As adults, children who are maltreated are more prone to unhealthy behaviors and conditions, such as drug and alcohol abuse, smoking, eating disorders, and depression. A previous study found that Project SafeCare, a treatment program that provides parent training to families with children who were at risk for or victims of maltreatment, resulted in fewer child welfare reports. Participants in Project SafeCare reported improvements in child healthcare, home safety, and parent-child relations. However, the study suggested that the SafeCare program may not be equally effective in decreasing the occurrence of all forms of child maltreatment, particularly child physical abuse. This study will determine the effectiveness of a complex evidence-based practice program, extending upon the SafeCare program, in reducing the occurrence of physical abuse and other forms of child maltreatment.
Participants in this study will receive services from Oklahoma Comprehensive Home-Based Services (CHBS), a program provided to families with issues of child abuse and neglect. Upon entry into the CHBS program, participants will undergo a computerized interview, lasting between 1 and 2 hours. The interview will include questions about family strengths and weaknesses, personal beliefs, substance abuse history, and opinion on CHBS. This computerized interview will be repeated at the end of treatment, approximately 6 to 12 months later. During the first few weeks of CHBS, an agent will make five visits to the homes of participants to observe pretreatment family life. Treatment services will concentrate on improving healthcare skills, parent-child interactions, and safety in homes and will specifically address ways to reduce physical abuse and other identified family issues. Study participation will continue for 12 months after completion of CHBS. Study researchers will obtain child welfare reports from the Department of Human Services (DHS) for up to 10 years after completion of CHBS.
- Conditions
- Child Abuse
- Being tested
- SafeCare
- Keywords
- Child Maltreatment, Child Neglect, Child Physical Abuse, Evidence-Based Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeCareBehavioural
Treatment will be based on an updated version of the SafeCare program, which specifically addresses parenting and discipline associated with child physical abuse. Participants will receive services from Comprehensive Home-Based Services.
| Study group | Role | What they receive |
|---|---|---|
| Managing Child Behavior | Experimental | Families with a high risk for or a history of child abuse and are enrolled in Comprehensive Home-Based Services and receive services as usual, which includes SafeCare, plus Managing Child Behavior module if they report significant behavior problems with their child between the ages of 2-12. Receives: Behavioral: SafeCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity of service provider
Measured: Measured throughout study
Secondary outcomes (1)
Parent behavior
Measured: Measured at baseline and at some point between Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionNov 2012
- Study completionNov 2012
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 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Debra B. Hecht, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595010
- Sponsor's protocol ID
- R34MH076972
- Other IDs
- R34MH076972
- Status last verified
- Jun 2016
- First submitted
- 4 Jan 2008
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Multi-Component Evidence Based Practice in Child Abuse Service Systems
- ClinicalTrials.gov ID
- NCT00595010
- Acronym / sponsor ID
- R34MH076972
- Conditions
- Child Abuse
- Keywords
- Child Maltreatment, Child Neglect, Child Physical Abuse, Evidence-Based Practice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 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.
This study will determine the effectiveness of a complex parent training program, based on the SafeCare model, in reducing the occurrence of child maltreatment.
Detailed description
Child maltreatment is the general term used to characterize all forms of child abuse, including neglect and physical, sexual, and emotional abuse. These forms of maltreatment can lead to a large number of child developmental, emotional, and behavioral difficulties. As adults, children who are maltreated are more prone to unhealthy behaviors and conditions, such as drug and alcohol abuse, smoking, eating disorders, and depression. A previous study found that Project SafeCare, a treatment program that provides parent training to families with children who were at risk for or victims of maltreatment, resulted in fewer child welfare reports. Participants in Project SafeCare reported improvements in child healthcare, home safety, and parent-child relations. However, the study suggested that the SafeCare program may not be equally effective in decreasing the occurrence of all forms of child maltreatment, particularly child physical abuse. This study will determine the effectiveness of a complex evidence-based practice program, extending upon the SafeCare program, in reducing the occurrence of physical abuse and other forms of child maltreatment.
Participants in this study will receive services from Oklahoma Comprehensive Home-Based Services (CHBS), a program provided to families with issues of child abuse and neglect. Upon entry into the CHBS program, participants will undergo a computerized interview, lasting between 1 and 2 hours. The interview will include questions about family strengths and weaknesses, personal beliefs, substance abuse history, and opinion on CHBS. This computerized interview will be repeated at the end of treatment, approximately 6 to 12 months later. During the first few weeks of CHBS, an agent will make five visits to the homes of participants to observe pretreatment family life. Treatment services will concentrate on improving healthcare skills, parent-child interactions, and safety in homes and will specifically address ways to reduce physical abuse and other identified family issues. Study participation will continue for 12 months after completion of CHBS. Study researchers will obtain child welfare reports from the Department of Human Services (DHS) for up to 10 years after completion of CHBS.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Managing Child Behavior | Experimental | Behavioral: SafeCareFamilies with a high risk for or a history of child abuse and are enrolled in Comprehensive Home-Based Services and receive services as usual, which includes SafeCare, plus Managing Child Behavior module if they report significant behavior problems with their child between the ages of 2-12. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in Oklahoma Comprehensive Home-Based Services (CHBS)
- Child referred by Office of Community Services
Key exclusion criteria (2 listed)
- Primary referral of sexual abuse
- Primary referral goal to maintain permanent placement
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 |
|---|---|---|
| SafeCareTreatment will be based on an updated version of the SafeCare program, which specifically addresses parenting and discipline associated with child physical abuse. Participants will receive services from Comprehensive Home-Based Services. | Behavioural | Managing Child Behavior |
Primary outcome
Fidelity of service provider
Time frame: Measured throughout study
1 secondary outcome
Parent behavior
Time frame: Measured at baseline and at some point between Months 6 and 12
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 9 Jun 2016.
- Individual participant dataSharing planned: No
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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.
Debra B. Hecht, PhD principal investigator
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SafeCare in people with Child Abuse, run by University of Oklahoma.
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 2 inclusion and 2 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 9 Jun 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Fidelity of service provider (time frame: Measured throughout study). 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 9 Jun 2016.