Child NeglectNCT01391754
Effectiveness Trial for Project SafeCare for Child Neglect
A study testing SafeCare, Services As Usual and Uncoached in people with Child Neglect, run by University of Oklahoma at 3 sites in United States.
Trial summary
The study is a field trial comparing the SafeCare family preservation model to a comparable usual care model for parents in child welfare. The study also compares two levels of service quality control. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Child Neglect
- What is being tested?
- SafeCare, Services As Usual and Uncoached
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,175 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2003to Sep 2007
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents in the child welfare system for neglect with or without physical abuse
Who cannot join
- Parents in the child welfare system for sexual abuse
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eastern Oklahoma Youth Services
McAlester, Oklahoma, 74501
NorthCare
Oklahoma City, Oklahoma, 73112
Family and Children's Services
Tulsa, Oklahoma, 74120
About this study
The study is a field trial comparing the SafeCare family preservation model to a comparable usual care model for parents in child welfare. The study also compares two levels of service quality control.
Read the detailed description
The study is a cluster-randomized field trial of the SafeCare(SC) home-based family preservation model for families in the child welfare system. The trial is conducted in collaboration with the state child welfare agency and their contracted in-home service system. The service system is regionalized and provides in home services to families referred by child welfare. Regions of the state are assigned by the study to either the SC model or to services as usual. Provider teams, nested within regions, are assigned to either a monitored or unmonitored model implementation quality control condition. The aims of the project are to test client level child welfare reentry outcomes between SC and standard conditions, across the two implementation and quality control conditions.
- Conditions
- Child Neglect
- Being tested
- SafeCare, In vivo coached quality control, Services As Usual, Uncoached
- Keywords
- child abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeCareBehavioural
Behavioral home based family preservation. Weekly visits X six months.
In vivo coached quality controlOther
Live observation of practice with expert coaching, feedback and fidelity monitoring
Services As UsualBehavioural
Home based services not using the SafeCare model
UncoachedOther
No in vivo coached quality control or fidelity monitoring
| Study group | Role | What they receive |
|---|---|---|
| SafeCare with Coached Implementation | Experimental | Home-based services with the SafeCare model, implemented with in vivo provider coaching as quality control Receives: Behavioral: SafeCare; Other: In vivo coached quality control |
| SafeCare without Coaching | Experimental | Home-based services using the SafeCare model, implemented without in vivo coached implementation quality control Receives: Behavioral: SafeCare; Other: Uncoached |
| Services As Usual with Coaching | Experimental | Usual home based services, with in vivo coached implementation quality control Receives: Other: In vivo coached quality control; Behavioral: Services As Usual |
| Services As Usual Without Coaching | Active comparator | Usual home based services without in vivo coached quality control Receives: Behavioral: Services As Usual; Other: Uncoached |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child welfare system recidivism
Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system
Measured: Up to 2766 days
Secondary outcomes (5)
Child Abuse Potential Inventory
This is a questionnaire survey measuring parenting distress, parenting attitudes, and risk for committing child abuse
Measured: Approximately 180 days and 365 days
Family Resources Scale
This is a questionnaire survey measuring sufficiency of basic concrete resources in a family, such as adequate food, shelter, utilities, clothing, access to health care, etc.
Measured: Approximately 180 and 365 days
Beck Depression Inventory
This is a questionnaire measuring symptoms of depression
Measured: Approximately 180 and 365 days
Social Provisions Scale
This is a questionnaire measuring the degree of social support and quality of social relationships
Measured: Approximately 180 and 356 days
Diagnostic Interview Schedule--Drug and Alcohol Disorders Module
This is a structured diagnostic psychiatric interview, adapted to questionnaire format, measuring symptoms of alcohol disorders and drug disorders, with associated DSM based diagnostic algorithms.
Measured: Approximately 180 and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startOct 2003
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Child NeglectStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Centers for Disease Control and Prevention, Oklahoma Department of Health and Human Services
- Investigators
- Mark Chaffin, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391754
- Sponsor's protocol ID
- 5R01MH065667
- Status last verified
- Jul 2011
- First submitted
- 29 Jun 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aarons GA, Sommerfeld DH, Hecht DB, Silovsky JF, Chaffin MJ. The impact of evidence-based practice implementation and fidelity monitoring on staff turnover: evidence for a protective effect. J Consult Clin Psychol. 2009 Apr;77(2):270-80. doi: 10.1037/a0013223.
PubMed 19309186Chaffin M, Bard D. Changes in parental depression symptoms during family preservation services. Child Abuse Negl. 2011 Jun;35(6):448-58. doi: 10.1016/j.chiabu.2011.02.005. Epub 2011 Jun 1.
PubMed 21632109Chaffin M, Bard D, Hecht D, Silovsky J. Change trajectories during home-based services with chronic child welfare cases. Child Maltreat. 2011 May;16(2):114-25. doi: 10.1177/1077559511402048. Epub 2011 Apr 13.
PubMed 21493617
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Trial for Project SafeCare for Child Neglect
- ClinicalTrials.gov ID
- NCT01391754
- Acronym / sponsor ID
- 5R01MH065667
- Conditions
- Child Neglect
- Keywords
- child abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,175 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Centers for Disease Control and Prevention, Oklahoma Department of Health and Human Services
- Study start
- Oct 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 12 Jul 2011 (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 is a field trial comparing the SafeCare family preservation model to a comparable usual care model for parents in child welfare. The study also compares two levels of service quality control.
Detailed description
The study is a cluster-randomized field trial of the SafeCare(SC) home-based family preservation model for families in the child welfare system. The trial is conducted in collaboration with the state child welfare agency and their contracted in-home service system. The service system is regionalized and provides in home services to families referred by child welfare. Regions of the state are assigned by the study to either the SC model or to services as usual. Provider teams, nested within regions, are assigned to either a monitored or unmonitored model implementation quality control condition. The aims of the project are to test client level child welfare reentry outcomes between SC and standard conditions, across the two implementation and quality control conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SafeCare with Coached Implementation | Experimental | Behavioral: SafeCare, Other: In vivo coached quality controlHome-based services with the SafeCare model, implemented with in vivo provider coaching as quality control |
| SafeCare without Coaching | Experimental | Behavioral: SafeCare, Other: UncoachedHome-based services using the SafeCare model, implemented without in vivo coached implementation quality control |
| Services As Usual with Coaching | Experimental | Other: In vivo coached quality control, Behavioral: Services As UsualUsual home based services, with in vivo coached implementation quality control |
| Services As Usual Without Coaching | Active comparator | Behavioral: Services As Usual, Other: UncoachedUsual home based services without in vivo coached quality control |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents in the child welfare system for neglect with or without physical abuse
Key exclusion criteria (1 listed)
- Parents in the child welfare system for sexual abuse
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 |
|---|---|---|
| SafeCareBehavioral home based family preservation. Weekly visits X six months. | Behavioural | SafeCare with Coached Implementation, SafeCare without Coaching |
| In vivo coached quality controlLive observation of practice with expert coaching, feedback and fidelity monitoring | Other | SafeCare with Coached Implementation, Services As Usual with Coaching |
| Services As UsualHome based services not using the SafeCare model | Behavioural | Services As Usual Without Coaching, Services As Usual with Coaching |
| UncoachedNo in vivo coached quality control or fidelity monitoring | Other | SafeCare without Coaching, Services As Usual Without Coaching |
Primary outcome
Child welfare system recidivism
Time frame: Up to 2766 days
Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system
5 secondary outcomes
Child Abuse Potential Inventory
Time frame: Approximately 180 days and 365 days
Family Resources Scale
Time frame: Approximately 180 and 365 days
Beck Depression Inventory
Time frame: Approximately 180 and 365 days
Social Provisions Scale
Time frame: Approximately 180 and 356 days
Diagnostic Interview Schedule--Drug and Alcohol Disorders Module
Time frame: Approximately 180 and 365 days
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 12 Jul 2011.
- Results publication: PubMed 19309186Aarons GA, Sommerfeld DH, Hecht DB, Silovsky JF, Chaffin MJ. The impact of evidence-based practice implementation and fidelity monitoring on staff turnover: evidence for a protective effect. J Consult Clin Psychol. 2009 Apr;77(2):270-80. doi: 10.1037/a0013223.
- Results publication: PubMed 21632109Chaffin M, Bard D. Changes in parental depression symptoms during family preservation services. Child Abuse Negl. 2011 Jun;35(6):448-58. doi: 10.1016/j.chiabu.2011.02.005. Epub 2011 Jun 1.
- Results publication: PubMed 21493617Chaffin M, Bard D, Hecht D, Silovsky J. Change trajectories during home-based services with chronic child welfare cases. Child Maltreat. 2011 May;16(2):114-25. doi: 10.1177/1077559511402048. Epub 2011 Apr 13.
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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.
Mark Chaffin, PhD principal investigator
University of Oklahoma
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SafeCare, Services As Usual and Uncoached in people with Child Neglect, run by University of Oklahoma at 3 sites 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 1 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 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Child welfare system recidivism (time frame: Up to 2766 days). 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 NCT01391754, which also lists 3 linked publications.
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 12 Jul 2011.