NCT03198429

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

4.2 years

First QC Date

March 23, 2017

Last Update Submit

June 22, 2017

Conditions

Keywords

domestic violencedyadic mother-child interventionfathersparentingyoung children

Outcome Measures

Primary Outcomes (1)

  • Recurrence of abuse

    Substantiated re-referral to child protective services for child maltreatment (any form).

    2 years

Secondary Outcomes (5)

  • Workers' case conceptualization of the risks/needs of mothers

    Average of 14 months post-assignment

  • Workers' case conceptualization of the risks/needs of fathers

    Average of 14 months post-assignment

  • Workers' efficacy for using embedded parenting interventions with mothers

    Average of 14 months post-assignment

  • Workers' efficacy for using embedded parenting interventions with fathers

    Average of 14 months post-assignment

  • Child social and emotional development (Ages & Stages Questionnaires-Social Emotional (ASQ-SE), 2nd Ed)

    Average of 12 months

Study Arms (4)

Embedded fathering intervention

EXPERIMENTAL

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

Embedding mother-child intervention

EXPERIMENTAL

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

Combined intervention

EXPERIMENTAL

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 DadsBehavioral: Mothers in Mind

Treatment as usual

NO INTERVENTION

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.

Interventions

Caring DadsBEHAVIORAL

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.

Combined interventionEmbedded fathering intervention
Mothers in MindBEHAVIORAL

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.

Combined interventionEmbedding mother-child intervention

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Child Welfare Institute

Toronto, Ontario, M4Y 1n1, Canada

RECRUITING

University of Toronto

Toronto, Ontario, M5S1V6, Canada

RECRUITING

Study Officials

  • Katreena Scott, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katreena Scott, PhD

CONTACT

Ethics Review Office

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Randomly assigned groups are: 1) treatment as usual; 2) embedded father intervention; 3) embedded mother-child intervention; 4) embedded father and mother-child intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 23, 2017

First Posted

June 26, 2017

Study Start

October 31, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations