Effectiveness Trial for Project SafeCare for Child Neglect

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Effectiveness Trial for Project SafeCare for Child Neglect

Conditions
-----------------
Child Neglect

Intervention / Treatment
-----------------
* Behavioral: SafeCare
* Other: In vivo coached quality control
* Behavioral: Services As Usual
* Other: Uncoached


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents in the child welfare system for neglect with or without physical abuse Exclusion Criteria: Parents in the child welfare system for sexual abuse

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SafeCare with Coached Implementation<br>Home-based services with the SafeCare model, implemented with in vivo provider coaching as quality control | Behavioral: SafeCare<br>* Behavioral home based family preservation. Weekly visits X six months.<br>Other: In vivo coached quality control<br>* Live observation of practice with expert coaching, feedback and fidelity monitoring<br>|
| Experimental: SafeCare without Coaching<br>Home-based services using the SafeCare model, implemented without in vivo coached implementation quality control | Behavioral: SafeCare<br>* Behavioral home based family preservation. Weekly visits X six months.<br>Other: Uncoached<br>* No in vivo coached quality control or fidelity monitoring<br>|
| Experimental: Services As Usual with Coaching<br>Usual home based services, with in vivo coached implementation quality control | Other: In vivo coached quality control<br>* Live observation of practice with expert coaching, feedback and fidelity monitoring<br>Behavioral: Services As Usual<br>* Home based services not using the SafeCare model<br>|
| Active Comparator: Services As Usual Without Coaching<br>Usual home based services without in vivo coached quality control | Behavioral: Services As Usual<br>* Home based services not using the SafeCare model<br>Other: Uncoached<br>* No in vivo coached quality control or fidelity monitoring<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child welfare system recidivism | Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system | Up to 2766 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Abuse Potential Inventory | This is a questionnaire survey measuring parenting distress, parenting attitudes, and risk for committing child abuse | 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. | Approximately 180 and 365 days | 
| Beck Depression Inventory | This is a questionnaire measuring symptoms of depression | Approximately 180 and 365 days | 
| Social Provisions Scale | This is a questionnaire measuring the degree of social support and quality of social relationships | 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. | Approximately 180 and 365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
child abuse