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Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence (SafeUnderstood)

This study is currently recruiting participants.
Verified June 2017 by Katreena Scott, University of Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT03198429
First Posted: June 26, 2017
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Child Development Institute
Children's Aid Society of Toronto Child Welfare Institute
Information provided by (Responsible Party):
Katreena Scott, University of Toronto
  Purpose

The current cluster randomized trial examines the efficacy of embedding two different parenting interventions within child protection services for young children (0 to 4) who have been exposed to domestic violence and who are at moderate to high risk for recurrent experiences of maltreatment. Interventions are "embedded" in recognition of the significant role played by child protection case workers in identifying families in need of intervention, referring/engaging families in intervention, and being able to use information resulting from intervention (e.g., reports from the intervention program, observations of parenting behaviour changes made as a result of intervention) to improve decision-making in their child protection practice. Thus in this trial, ongoing child protection case workers for families are randomly assigned to receive professional development training, supervision support, and priority client access to parenting interventions in the following four conditions: a) embedded mother-child dyadic intervention (Mothers in Mind); b) embedded fathering intervention (Caring Dads); c) both mother-child dyadic and fathering intervention; d) service as usual.

Mothers in Mind (MIM) is a dyadic mother-child intervention aimed at preventing child impairment resulting from exposure to domestic violence. Intervention focuses on increasing mothers' awareness of the impact that exposure to family violence/trauma may have had on their infants and themselves as mothers, helping identify and promote positive parenting skills such as sensitivity and responsiveness to infant needs, promoting parental competence and emotional closeness and decreasing mothers' social isolation. Mothers in Mind uses an attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10 group and 2 individual).

Caring Dads (CD) aims to prevent recurrence of child exposure to domestic violence by intervening with fathers. Caring Dads includes 15 group sessions, an individual intake, and two individual sessions to set and monitor specific behaviour change goals. Major aspects of innovation in the Caring Dads program include the use of a motivational approach to engage and retain men in intervention, consistent emphasis on the need to end violence against children's mothers alongside of improving fathering; program content addressing accountability for past abuse; focus on promoting child-centered fathering over developing child management skills; and a model of collaborative practice with child protection.

Hypotheses are posed for differential outcomes among child protection workers (level of randomization) and for children who are the subject of the child protection referral (nested within workers). At the level of the individual child (primary outcome) it is hypothesized that there will be lower rates of re-referral for children of families on the caseloads of child protection workers assigned to the embedded CD, MIM and combined intervention than for those on the caseloads of workers in the service as usual condition. At the worker level (secondary outcomes), outcomes are hypothesized in two areas: 1) worker skill in conceptualizing risk and need in cases of child exposure to domestic violence and 2) increased self-efficacy for referring to and collaborating with embedded interventions. Specifically, we hypothesized that following training and at 12-month follow-up, workers in the CD/MIM intervention and combined CD and MIM condition will have greater case conceptualization skills in responding to hypothetical cases as compared to workers in the treatment as usual condition. We further hypothesize that assignment to an intervention condition will lead workers to report greater self-efficacy for collaborating with embedded parenting interventions than workers in the treatment as usual condition post-training and at 12-months follow-up.


Condition Intervention
Domestic Violence Child Abuse Behavioral: Caring Dads Behavioral: Mothers in Mind

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Randomly assigned groups are: 1) treatment as usual; 2) embedded father intervention; 3) embedded mother-child intervention; 4) embedded father and mother-child intervention
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cluster Randomized Trial of Embedded Dyadic Mother-child and Father-focused Intervention for Preventing Recurrence of Maltreatment and Reducing Impairment in Young Children Exposed to Domestic Violence

Resource links provided by NLM:


Further study details as provided by Katreena Scott, University of Toronto:

Primary Outcome Measures:
  • Recurrence of abuse [ Time Frame: 2 years ]
    Substantiated re-referral to child protective services for child maltreatment (any form).


Secondary Outcome Measures:
  • Workers' case conceptualization of the risks/needs of mothers [ Time Frame: Average of 14 months post-assignment ]
    Assessed via worker response to hypothetical vignettes (A, B and C) typical of cases of child exposure to DV given to workers in randomly assigned order. Each vignette is followed by three questions: Identify the risks to the child; Create an intervention plan for the family; and How would you know when this case should be closed? Scoring criteria for vignettes were developed on the basis of the responses of six experts. The number and nature of expert identified risks (9 to 10), needs (5 to 6), and indicators for closure (4 to 6) vary across the mother and father domains and across vignettes. For each identified item, workers will be assigned a score of 0 (not identified or mentioned), 1 (identified or mentioned but not clearly conceptualized) or 2 (well conceptualized) by raters blind to intervention status, summed across items, and standardized to allow direct comparisons.

  • Workers' case conceptualization of the risks/needs of fathers [ Time Frame: Average of 14 months post-assignment ]
    Assessed via worker response to hypothetical vignettes (A, B and C) typical of cases of child exposure to DV given to workers in randomly assigned order. Each vignette is followed by three questions: Identify the risks to the child; Create an intervention plan for the family; and How would you know when this case should be closed? Scoring criteria for vignettes were developed on the basis of the responses of six experts. The number and nature of expert identified risks (9 to 10), needs (5 to 6), and indicators for closure (4 to 6) vary across the mother and father domains and across vignettes. For each identified item, workers will be assigned a score of 0 (not identified or mentioned), 1 (identified or mentioned but not clearly conceptualized) or 2 (well conceptualized) by raters blind to intervention status, summed across items, and standardized to allow direct comparisons.

  • Workers' efficacy for using embedded parenting interventions with mothers [ Time Frame: Average of 14 months post-assignment ]
    10-item self-report likert scale with each item rated from 1 (strongly disagree) to 7 (strongly agree). Example items include: "I am confident that I know when I have the skills to help mothers myself and when a referral to a more specialized service is necessary"; "When I refer a mother to intervention, I have specific idea(s) of the changes that I want to see her make" and "I feel like I have a range of ideas about what to do when mothers seem to be "failing" in intervention". Total score for self-efficacy in using embedded parenting intervention with mothers will be created by averaging across items.

  • Workers' efficacy for using embedded parenting interventions with fathers [ Time Frame: Average of 14 months post-assignment ]
    10-item self-report likert scale with each item rated from 1 (strongly disagree) to 7 (strongly agree). Example items include: "I am confident that I know when I have the skills to help fathers myself and when a referral to a more specialized service is necessary"; "When I refer a father to intervention, I have specific idea(s) of the changes that I want to see her make" and "I feel like I have a range of ideas about what to do when fathers seem to be "failing" in intervention". Total score for self-efficacy in using embedded parenting intervention with fathers will be created by averaging across items.

  • Child social and emotional development (Ages & Stages Questionnaires-Social Emotional (ASQ-SE), 2nd Ed) [ Time Frame: Average of 12 months ]
    Children's caregivers (mothers and/or fathers) will compete the ASQ-SE to assess young children's social and emotional development. Questionnaire items are age specific for children 6 months to 5.5 years of age with stages that focus on tasks related to attachment (0-12 months), autonomy and self-development (12-20 months), and establishing peer relationships (30 months-7 years). Specific behavioral domains addressed include: self-regulation, compliance, communication, adaptive behaviors, autonomy, affect, and interaction with people. Each item is rated on a three point scale "most of the time", "some of the time", or "rarely" and summed to create an overall social and emotional development score.


Estimated Enrollment: 200
Actual Study Start Date: October 31, 2016
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Embedded fathering intervention

This condition focuses on workers' practice with fathers who have been identified as perpetrators in cases of child exposure to domestic violence. Workers randomly assigned to this condition will receive:

  1. a one-day training at the beginning of the study on the need to engage fathers as part of intervention in cases of child exposure to DV
  2. access to a practice leader and consultant to respond to question and concerns about working with father perpetrators of DV
  3. access to a 30-minute presentation, once a month, on issues of practice specific to working with this population In addition,
  4. cases being assigned to ongoing service workers will be "flagged" by intake at the time they are opened to ongoing services as being a potentially appropriate referral to the Caring Dads program
  5. clients who are then referred to CD as part of clinical service will be given access to this program at the earliest possible opportunity.
Behavioral: Caring Dads
Caring Dads is a 15-week group intervention program for fathers, with an intensive intake and two additional individual sessions to set and monitor specific, individualized change goals. Major aspects of innovation in the Caring Dads program include: the use of a motivational approach to engage and retain men in intervention; consistent emphasis on the need to end violence against children's mothers alongside of improving fathering; program content addressing accountability for past abuse and a model of collaborative practice with child protection. The Caring Dads program was developed with a specific commitment to remain focused on the safety and well-being needs of children as a primary goal of intervention and with the recognition that children's safety and well-being is integrally connected to that of their mothers.
Experimental: Embedding mother-child intervention

Workers in the MIM condition will receive additional training and facilitated referral to MIM for eligible clients. Specifically, workers randomly assigned to this condition will receive:

  1. a one-day training at the beginning of the study on the impact of DV on mothers, mothering, and child development
  2. access to a practice leader and consultant to respond to question and concerns about working with women victims of DV on parenting issues
  3. access to a 30-minute presentation, once a month, on issues of practice specific to working with this population In addition,
  4. cases judged by intake workers as being appropriate referrals to the MIM program (see Methods) and being assigned to these workers for ongoing service will be "flagged" at the time of transfer as being potentially appropriate referrals to the Mothers in Mind program
  5. clients who are then referred to MIM as part of clinical service will be given access to this program at the earliest possible opportunity.
Behavioral: Mothers in Mind
Mothers in Mind uses an attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10 of which are in group) with mothers. These sessions focus on raising awareness and validation about the experience of violence and the impact it has on mothering. Specifically, MIM increases mothers' awareness of the impact that exposure to family violence/trauma may have had on their infants and themselves as mothers, helps identify and promote positive parenting skills such as sensitivity and responsiveness to infant needs by increasing parental competence, helps promote emotional closeness and decreasing mothers' social isolation, increases mother and infant physical safety, and encourages positive attachment processes.
Experimental: Combined intervention
A final group of workers will be randomly assigned to receive all the training, support, and referral opportunities associated with both the Embedded Mothers in Mind condition and the Embedded Caring Dads condition.
Behavioral: Caring Dads
Caring Dads is a 15-week group intervention program for fathers, with an intensive intake and two additional individual sessions to set and monitor specific, individualized change goals. Major aspects of innovation in the Caring Dads program include: the use of a motivational approach to engage and retain men in intervention; consistent emphasis on the need to end violence against children's mothers alongside of improving fathering; program content addressing accountability for past abuse and a model of collaborative practice with child protection. The Caring Dads program was developed with a specific commitment to remain focused on the safety and well-being needs of children as a primary goal of intervention and with the recognition that children's safety and well-being is integrally connected to that of their mothers.
Behavioral: Mothers in Mind
Mothers in Mind uses an attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10 of which are in group) with mothers. These sessions focus on raising awareness and validation about the experience of violence and the impact it has on mothering. Specifically, MIM increases mothers' awareness of the impact that exposure to family violence/trauma may have had on their infants and themselves as mothers, helps identify and promote positive parenting skills such as sensitivity and responsiveness to infant needs by increasing parental competence, helps promote emotional closeness and decreasing mothers' social isolation, increases mother and infant physical safety, and encourages positive attachment processes.
No Intervention: Treatment as usual
Workers in the service as usual condition will continue to provide in-home support to children and families in accordance with current practice. Workers will receive regular supervision from their supervisors. A review of practice reveals that, in general, workers make referrals to intervention programs in only a small minority of cases. Such referrals will continue under this study protocol - service will proceed as usual. This condition is not a placebo, families are continuing to receive the full child protection service that they would normally have received if this trail were not being run.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Did the intake process substantiate child exposure to domestic violence as a primary or secondary code (Yes)
  • Was the child's father (biological, step, or common-law) identified as a perpetrator of this abuse(need not be exclusive perpetrator)? (Yes)
  • Is at least one of the investigated children four years old or younger (yes for MIM comparison)?
  • Does the maltreated child reside with his or her mother or father or with his or her mother with ongoing regular contact with his/her father? (Yes)
  • Are there continuing and insufficiently addressed concerns about the potential recurrence of domestic violence by father (Yes)
  • Are there continuing and insufficiently addressed concerns about problems in the mother-child relationship? (Yes)

Exclusion Criteria:

  • The child's mother and father are unable to communicate in English
  • Given the opportunity, this father could not participate in a group-based intervention (reasons are documented. Examples would be severe mental health/substance use issues, severe problems with cognitive functioning, a work schedule that requires him to be regularly out of the region)
  • Given the opportunity, this mother could not participate in a group-based intervention? (reasons are documented. Examples would be severe mental health/substance use issues, severe problems with cognitive functioning, inability to arrange with work schedule)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198429


Contacts
Contact: Katreena Scott, PhD 416-978-0971 katreena.scott@utoronto.ca
Contact: Ethics Review Office 4169783272 ethics.review@utoronto.ca

Locations
Canada, Ontario
Child Welfare Institute Recruiting
Toronto, Ontario, Canada, M4Y 1n1
Contact: Deborah Goodman, PhD    4162351246    dgoodman@torontocas.ca   
University of Toronto Recruiting
Toronto, Ontario, Canada, M5S1V6
Contact: Katreena Scott, PhD    4169780971    katreena.scott@utoronto.ca   
Contact: Ethics Review Office    4169783272    ethics.review@utoronto.ca   
Sub-Investigator: Angelique Jenney, PhD         
Sponsors and Collaborators
University of Toronto
Child Development Institute
Children's Aid Society of Toronto Child Welfare Institute
Investigators
Principal Investigator: Katreena Scott, PhD University of Toronto
  More Information

Responsible Party: Katreena Scott, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT03198429     History of Changes
Other Study ID Numbers: 1516-HQ-000048
First Submitted: March 23, 2017
First Posted: June 26, 2017
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katreena Scott, University of Toronto:
domestic violence
dyadic mother-child intervention
fathers
parenting
young children

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes