Parenting Clinical Trial
Official title:
Promoting Healthy Families: A Canadian Evaluation of Two Evidence-based Parenting Programs
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Institute for Clinical Evaluative Sciences, Ontario Child Health Support Unit, Public Health Agency of Canada (PHAC), University of Manitoba |
Canada,
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
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. |
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