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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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 groups in NCT00595010
Study groupRoleWhat they receive
Managing Child BehaviorExperimentalFamilies 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.

  1. Fidelity of service provider

    Measured: Measured throughout study

Secondary outcomes (1)
  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.

  1. First posted16 Jan 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

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)
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

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.

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