Table 2 Items from the World Health Organization Trial Registration Data Set
Data category | Information |
|---|---|
Primary registry and trial identifying number | Australian New Zealand Clinical Trials Registry: ACTRN12613001281785 |
Date of registration in primary registry | 20 November 2013 |
Secondary identifying numbers | N/A |
Source(s) of monetary or material support | Australian Research Council’s (ARC) Discovery Projects scheme |
(Project ID: DP140100781) | |
Primary sponsor | N/A |
Secondary sponsor(s) | N/A |
Contact for public queries | Dr Alina Morawska |
Contact for scientific queries | Dr Alina Morawska |
Public title | Efficacy of the Positive Parenting Program (Triple P) for parents of young children with type 1 diabetes |
Scientific title | Efficacy of the Positive Parenting Program (Triple P) for parents of children with type 1 diabetes in improving parenting skills and confidence relating to general child behaviour and illness management? |
Countries of recruitment | Australia |
Health condition(s) or problem(s) studied | Type 1 diabetes (Illness severity/control) |
Parenting practices/behaviour | |
Child behaviour and adjustment | |
Parent adjustment and stress | |
Child illness behaviour | |
Parenting efficacy | |
Child's quality of life | |
Family quality of life | |
Intervention(s) | 2 × 2 h Positive Parenting for Healthy Living group discussion sessions |
Key inclusion and exclusion criteria | The key inclusion criteria is: (i) presence in the family of a 2-10 year old child; and (ii) child has diagnosis of type 1 diabetes. |
The exclusion criteria include: (i) child has a disability including language and speech impairment; (ii) parents are currently seeing a professional for the child’s behaviour difficulties; (iii) parents are currently receiving psychological help or counselling; (iv) parents have difficulties in reading a newspaper or (v) the child has been diagnosed in the last three months. | |
Study type | RCT, 2 × 3 design, superiority trial, 1:1 allocation ratio |
Date of first enrolment | May 2014 |
Target sample size | 60 |
Recruitment status | Recruiting |
Primary outcome(s) | Parenting practices/behaviour |
Child behaviour and adjustment | |
Child’s quality of life | |
Key secondary outcomes | Illness severity and control |
Parent adjustment and stress | |
Child illness behaviour | |
Parenting efficacy | |
Family quality of life |