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Promoting Healthy Families: A Canadian Evaluation

Primary Purpose

Child Behavior Problem, Parenting

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Triple P
Circle of Security Parenting
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Behavior Problem

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Caregivers of children are eligible for inclusion if:

  • Custodial caregiver of child is aged 2 to 6 years at time of screening.
  • Families with sufficient knowledge of English needed for assessment measures.
  • Caregivers capable of giving informed, written consent.
  • Definition of 'at-risk' as measured by one of the following criteria as outlined below:

    • Elevated child emotional behavioural problems as indexed by above- population mean total scores on the Strengths and Difficulties Questionnaire (SDQ); OR
    • One of the following family or contextual risk factor
    • Parental challenge - parental mental health problems, as indexed by score on K6 distress scale ≥ 13; adolescent parent status (less than 20 years of age); single parent status; OR Sociodemographic risk factor - parent with less than grade 12 education; parent on social assistance;
    • Expressed difficulties with parenting: Do you often feel like your child is difficult to take care of?

Exclusion Criteria:

• Children with suspected severe to profound developmental delay.

Sites / Locations

  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Triple P (Positive Parenting Program)

Circle of Security Parenting

Treatment As Usual

Arm Description

Triple P - level 4 group: All 600 participants will undergo screening and a baseline assessment before randomization. Once randomized, the Triple P group (n=200) will be provided with 8-week group/individual sessions.

Circle of Security - Parenting (COS-P): Once randomized to the COSP group (n=200), caregivers will be provided with an 8-week group session.

Treatment as usual: Caregivers randomized to this arm (n=200) will receive either a different program, or brief services depending on the organization.

Outcomes

Primary Outcome Measures

Child emotional/behavioural problems
The investigators will measure change in child emotional and behavioural problems across time points.
Parenting Practices
Discipline style measured using the Parenting Scale

Secondary Outcome Measures

Average number of child hospitalizations and injuries
Data for the secondary outcomes will be derived from various ICES databases including Health Services Administrative Data (physician billings, inpatient hospital discharges and emergency and ambulatory care visits).
Change in Observed Parenting
Video-taped caregiver-child interactions

Full Information

First Posted
January 2, 2021
Last Updated
April 10, 2023
Sponsor
McMaster University
Collaborators
University of Manitoba, Institute for Clinical Evaluative Sciences, Ontario Child Health Support Unit, Public Health Agency of Canada (PHAC)
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1. Study Identification

Unique Protocol Identification Number
NCT04702191
Brief Title
Promoting Healthy Families: A Canadian Evaluation
Official Title
Promoting Healthy Families: A Canadian Evaluation of Two Evidence-based Parenting Programs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
University of Manitoba, Institute for Clinical Evaluative Sciences, Ontario Child Health Support Unit, Public Health Agency of Canada (PHAC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all. Using a three-armed randomized controlled trial, the aim of the current study is to evaluate the effectiveness of two parenting programs, the Triple P - Positive Parenting Program (group - level 4) and the Circle of Security Parenting Program (group) compared to treatment as usual in Ontario, Canada.
Detailed Description
The overall goal of the evaluation is to provide robust evidence about the implementation and effectiveness of two parenting programs, the Triple P and Circle of Security Parenting (COSP), in the province of Ontario, on parenting practices and functioning, and child emotional behaviour problems outcomes, and secondary outcomes including selected child maltreatment-related outcomes. These objectives will be achieved in two phases. The investigators will conduct a multi-site, three-arm randomized controlled trial of 600 participating caregivers and their children to compare Triple P (level 4 group) and COSP to treatment as usual (TAU) with respect to improving positive practices and child outcomes. Participants will be randomly assigned to one of the three conditions using stratified (by site) block randomization. All participants will undergo screening and a baseline assessment before randomization. Once randomized, the Triple P and COSP caregivers will receive 8-week session. The TAU group will receive a different program, or short therapy sessions depending on the organization. Caregivers will complete follow-up assessments at post-treatment, 6- and 12-months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Problem, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triple P (Positive Parenting Program)
Arm Type
Experimental
Arm Description
Triple P - level 4 group: All 600 participants will undergo screening and a baseline assessment before randomization. Once randomized, the Triple P group (n=200) will be provided with 8-week group/individual sessions.
Arm Title
Circle of Security Parenting
Arm Type
Experimental
Arm Description
Circle of Security - Parenting (COS-P): Once randomized to the COSP group (n=200), caregivers will be provided with an 8-week group session.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Treatment as usual: Caregivers randomized to this arm (n=200) will receive either a different program, or brief services depending on the organization.
Intervention Type
Behavioral
Intervention Name(s)
Triple P
Other Intervention Name(s)
Triple P - group level 4
Intervention Description
Triple P - level 4 group is a group-based parenting intervention for families with children who exhibit behavioural or emotional difficulties. Group sessions typically focus on topics such as positive parenting, helping children develop, managing misbehaviour, and planning ahead. Practitioners then provide individual feedback on progress using positive parenting strategies and goal setting. Trained practitioners will deliver the program according to the manualized protocol (Turner, Markie-Dadds, & Sanders, 2010). This will include eight weekly sessions with maximum of 12 parents. The first four sessions will be as group sessions. These four group sessions will be followed by three one-to-one practical and personalised telephone consultations. Finally, there will be one group session, which will complete the programme and parents' contact with the Triple P practitioners. The main aim of this session is to review progress and plan for the future.
Intervention Type
Behavioral
Intervention Name(s)
Circle of Security Parenting
Intervention Description
Circle of Security - Parenting (COS-P) will be delivered according to the protocol outlined by Cooper, Hoffman and Powell (Cooper et al., 2009). COS-P is a manualized eight-session parent-education group program which has the same broad aims and core components of the COS-Intensive model from which it was developed (i.e., to increase caregiver sensitivity and responsiveness to child cues, empathy for the child by supporting parental reflective functioning, recognition and understanding of child attachment cues, and awareness of the impact of the caregiver's own attachment history on caregiving patterns). The program is led by one or two facilitators and includes 10-12 caregivers. The program uses clinical DVD clips of problematic parent-child interaction and healthy alternatives to illustrate attachment patterns and parenting styles, and to promote group discussion.
Primary Outcome Measure Information:
Title
Child emotional/behavioural problems
Description
The investigators will measure change in child emotional and behavioural problems across time points.
Time Frame
6-months
Title
Parenting Practices
Description
Discipline style measured using the Parenting Scale
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Average number of child hospitalizations and injuries
Description
Data for the secondary outcomes will be derived from various ICES databases including Health Services Administrative Data (physician billings, inpatient hospital discharges and emergency and ambulatory care visits).
Time Frame
24 months
Title
Change in Observed Parenting
Description
Video-taped caregiver-child interactions
Time Frame
Baseline, 9-weeks, 6- and 12-months.
Other Pre-specified Outcome Measures:
Title
Caregiver Emotion Regulation
Description
Change in Parental Emotional Regulation will be measured using the Difficulties in Emotion Regulation Scale.
Time Frame
Baseline, 9-weeks, 6- and 12-months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Caregivers of children are eligible for inclusion if: Custodial caregiver of child is aged 2 to 6 years at time of screening. Families with sufficient knowledge of English needed for assessment measures. Caregivers capable of giving informed, written consent. Definition of 'at-risk' as measured by one of the following criteria as outlined below: Elevated child emotional behavioural problems as indexed by above- population mean total scores on the Strengths and Difficulties Questionnaire (SDQ); OR One of the following family or contextual risk factor Parental challenge - parental mental health problems, as indexed by score on K6 distress scale ≥ 13; adolescent parent status (less than 20 years of age); single parent status; OR Sociodemographic risk factor - parent with less than grade 12 education; parent on social assistance; Expressed difficulties with parenting: Do you often feel like your child is difficult to take care of? Exclusion Criteria: • Children with suspected severe to profound developmental delay.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Gonzalez, PhD
Phone
19055101652
Email
gonzal@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Gonzalez, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S3K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Gonzalez
Phone
19055101652
Email
gonzal@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Arnold, D.S., O'Leary, S.G., Wolff, L.S., & Acker, M.M. (1993). The Parenting Scale: A Measure of Dysfunctional Parenting in Discipline Situations. Psychological Assessment, 5(2), 137-144.
Results Reference
background
Citation
Cooper, G., Hoffman, K., Powell, B., & Marvin, R. (2005). The circle of security intervention: Differential diagnosis and differential treatment. In L. J. Berlin, Y. Ziv, L. Amaya-Jackson, & M. T. Greenberg (Eds.), Enhancing early attachments: Theory, research, intervention, and policy (pp. 127-151). New York, NY: The Guilford Press.
Results Reference
background
Citation
Cooper, G., Hoffman, K., & Powell, B. (2009). Circle of Security Parenting: A relationship based parenting program. Facilitator DVD Manual 5.0. Spokane, WA: Circle of Security International. Marycliff Institute.
Results Reference
background
PubMed Identifier
18475003
Citation
de Graaf I, Speetjens P, Smit F, de Wolff M, Tavecchio L. Effectiveness of the Triple P Positive Parenting Program on behavioral problems in children: a meta-analysis. Behav Modif. 2008 Sep;32(5):714-35. doi: 10.1177/0145445508317134. Epub 2008 May 12.
Results Reference
background
PubMed Identifier
11699809
Citation
Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
Results Reference
background
PubMed Identifier
17154732
Citation
Hoffman KT, Marvin RS, Cooper G, Powell B. Changing toddlers' and preschoolers' attachment classifications: the Circle of Security intervention. J Consult Clin Psychol. 2006 Dec;74(6):1017-26. doi: 10.1037/0022-006X.74.6.1017.
Results Reference
background
Citation
Kaufman, E.A., Xia, M., Fosco, G. et al. (2016). The Difficulties in Emotion Regulation Scale Short Form (DERS-SF): Validation and Replication in Adolescent and Adult Samples. Journal of Psychopathology and Behavioral Assessment, 38, 443-455 (2016).
Results Reference
background
PubMed Identifier
28143454
Citation
Marryat L, Thompson L, Wilson P. No evidence of whole population mental health impact of the Triple P parenting programme: findings from a routine dataset. BMC Pediatr. 2017 Jan 31;17(1):40. doi: 10.1186/s12887-017-0800-5.
Results Reference
background
PubMed Identifier
34816157
Citation
Maxwell AM, McMahon C, Huber A, Hawkins E, Reay RE. Addressing the Evidence Gap: Protocol for an Effectiveness Study of Circle of Security Parenting, an Attachment-Based Intervention. Front Glob Womens Health. 2020 Oct 22;1:575752. doi: 10.3389/fgwh.2020.575752. eCollection 2020.
Results Reference
background
Citation
Public Health Agency of Canada (2016). Chief Public Health Officer of Canada. Report on the State of Public Health in Canada 2016: A Focus on Family Violence in Canada. Cat: HP2-1DE-PDF. ISSN: 1924-7087. Pub: 160152. Ottawa.
Results Reference
background
PubMed Identifier
19160053
Citation
Prinz RJ, Sanders MR, Shapiro CJ, Whitaker DJ, Lutzker JR. Population-based prevention of child maltreatment: the U.S. Triple p system population trial. Prev Sci. 2009 Mar;10(1):1-12. doi: 10.1007/s11121-009-0123-3. Erratum In: Prev Sci. 2015 Jan;16(1):168.
Results Reference
background
PubMed Identifier
25483885
Citation
Prinz RJ, Sanders MR, Shapiro CJ, Whitaker DJ, Lutzker JR. Erratum to: Population-Based Prevention of Child Maltreatment:The U.S. Triple P System Population Trial. Prev Sci. 2015 Jan;16(1):168. doi: 10.1007/s11121-014-0538-3. No abstract available.
Results Reference
background
PubMed Identifier
26780665
Citation
Prinz RJ, Sanders MR, Shapiro CJ, Whitaker DJ, Lutzker JR. Addendum to "Population-Based Prevention of Child Maltreatment: The U.S. Triple P System Population Trial". Prev Sci. 2016 Apr;17(3):410-6. doi: 10.1007/s11121-016-0631-x.
Results Reference
background
PubMed Identifier
18461457
Citation
Sanders MR, Ralph A, Sofronoff K, Gardiner P, Thompson R, Dwyer S, Bidwell K. Every family: a population approach to reducing behavioral and emotional problems in children making the transition to school. J Prim Prev. 2008 May;29(3):197-222. doi: 10.1007/s10935-008-0139-7. Erratum In: J Prim Prev. 2014 Dec;35(6):451.
Results Reference
background
PubMed Identifier
22149480
Citation
Sanders MR. Development, evaluation, and multinational dissemination of the triple P-Positive Parenting Program. Annu Rev Clin Psychol. 2012;8:345-79. doi: 10.1146/annurev-clinpsy-032511-143104. Epub 2011 Dec 6.
Results Reference
background
PubMed Identifier
24842549
Citation
Sanders MR, Kirby JN, Tellegen CL, Day JJ. The Triple P-Positive Parenting Program: a systematic review and meta-analysis of a multi-level system of parenting support. Clin Psychol Rev. 2014 Jun;34(4):337-57. doi: 10.1016/j.cpr.2014.04.003. Epub 2014 Apr 26. Erratum In: Clin Psychol Rev. 2014 Dec;34(8):658.
Results Reference
background
PubMed Identifier
24207163
Citation
Spijkers W, Jansen DE, Reijneveld SA. Effectiveness of Primary Care Triple P on child psychosocial problems in preventive child healthcare: a randomized controlled trial. BMC Med. 2013 Nov 11;11:240. doi: 10.1186/1741-7015-11-240.
Results Reference
background
Citation
World Health Organization (WHO). (2006). Preventing Child Maltreatment: a guide to taking action and generating the evidence. Geneva, Switzerland: World Health Organization.
Results Reference
background

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Promoting Healthy Families: A Canadian Evaluation

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