Promoting Healthy Families: A Canadian Evaluation

Parenting Clinical Trial

Official title:

Promoting Healthy Families: A Canadian Evaluation of Two Evidence-based Parenting Programs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702191
• Other study ID #: 10583
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: McMaster University
• Contact: Andrea Gonzalez, PhD
• Phone: 19055101652
• Email: gonzal[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Behavior Problem
• Parenting
• Problem Behavior

Intervention

Behavioral:
• Triple P
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.
• Circle of Security Parenting
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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
McMaster University	Institute for Clinical Evaluative Sciences, Ontario Child Health Support Unit, Public Health Agency of Canada (PHAC), University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (18)

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.

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.

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.

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. — View 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. — View 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. — View 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).

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. — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View Citation

World Health Organization (WHO). (2006). Preventing Child Maltreatment: a guide to taking action and generating the evidence. Geneva, Switzerland: World Health Organization.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Emotion Regulation	Change in Parental Emotional Regulation will be measured using the Difficulties in Emotion Regulation Scale.	Baseline, 9-weeks, 6- and 12-months.
Primary	Child emotional/behavioural problems	The investigators will measure change in child emotional and behavioural problems across time points.	6-months
Primary	Parenting Practices	Discipline style measured using the Parenting Scale	6-months
Secondary	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).	24 months
Secondary	Change in Observed Parenting	Video-taped caregiver-child interactions	Baseline, 9-weeks, 6- and 12-months.