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Trial registered on ANZCTR


Registration number
ACTRN12617000998347
Ethics application status
Approved
Date submitted
5/07/2017
Date registered
11/07/2017
Date last updated
11/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The evaluation of the efficacy and cultural acceptability of Group Triple P – Positive Parenting Program with Brazilian parents: Randomized Controlled Trial
Scientific title
The evaluation of the efficacy and cultural acceptability of Group Triple P – Positive Parenting Program with Brazilian parents: Randomized Controlled Trial
Secondary ID [1] 292369 0
Nil known
Universal Trial Number (UTN)
U1111-1198-8517
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural problems 303930 0
Dysfunctional parenting behaviors 303942 0
Condition category
Condition code
Mental Health 303284 303284 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 303285 303285 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Positive Parenting Program (Triple P) is a unique system of parenting and family support, developed through over 30 years of research, that aims to provide parents with a range of strategies to promote parental confidence, skills and knowledge, reducing the risk of behavioural, emotional and developmental problems in children.
Group Triple-P has been chosen as the intervention to be used in this study because it has been previously evaluated and shows good efficacy. Involves active skills training to teach parents these key parenting strategies, including videotaped modelling of skills, roleplay, rehearsal and feedback. Group Triple P consists of four group sessions of 2 hours each and focus on the following topics: positive parenting, helping children develop, managing misbehaviour and planning ahead for high risk situations. For the purpose of this research the four sessions will be separated in two days: Day one – session 1 and session 2 and (after a week) Day two- session 3 and 4, in each day will be offered a coffee break between the sessions. Upon completion of the group sessions, parents will participate in three individual telephone consultations to assist parents to implement the skills learnt in the program, which will last 15-30 minutes each for two consecutive weeks, with one consultation every five days. After the telephone consultations, parents will return for a final 2 hours group session to summarize program content and discuss how to proceed after the program.
The group sessions will be audio-recorded for the purpose of ensuring that the intervention is implemented according to the research protocol.
Before the first group session, a workbook summarising the content of every session and suggested homework will be given to each parent. The program will be delivered in Portuguese and conducted by a trained psychologist (registered in Brazil) and accredited Triple P Practitioner. Moreover, in order to reduce common barriers to attendance, the program will be offered free of charge and, at each session, participants and their children will receive a free meal and free childcare.
Intervention code [1] 298545 0
Behaviour
Intervention code [2] 298546 0
Prevention
Intervention code [3] 298558 0
Treatment: Other
Comparator / control treatment
The control group will be a wait-list control. Parents in the waitlist control group will be assessed at the same time as the intervention group, and for ethical reasons, will receive a Triple P intervention after the study has been completed and all data has been collected.
Control group
Active

Outcomes
Primary outcome [1] 302666 0
Parental Attributions: composite measures using The Parent’s Attributions for Child’s Behaviour Measure (PACBM; Pidgeon & Sanders, 2004) and The Parent Cognition Scale (Snarr, Slep, & Grande, 2009).
Timepoint [1] 302666 0
- Baseline, post-intervention (immediately after the 6 weeks of intervention) and follow up (6 months from post-intervention)
Primary outcome [2] 302667 0
Parental behaviour as measured by the Parenting Scale (PS; Arnold, O'Leary, Wolff, & Acker, 1993).
Timepoint [2] 302667 0
- Baseline, post-intervention (immediately after the 6 weeks of intervention) and follow up (6 months from post-intervention)
Primary outcome [3] 302668 0
Child emotional and behavioural problems: composite measures using the Child Adjustment and Parent Efficacy Scale (CAPES; Morawska, Sanders, Haslam, & Fletcher, 2014) and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999).
Timepoint [3] 302668 0
- Baseline, post-intervention (immediately after the 6 weeks of intervention) and follow up (6 months from post-intervention)
Secondary outcome [1] 336716 0
Parental adjustment as assessed by the Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995).
Timepoint [1] 336716 0
- Baseline, post-intervention (immediately after the 6 weeks of intervention) and follow up (6 months from post-intervention)
Secondary outcome [2] 336717 0
Program satisfaction as assessed by The Client Satisfaction Questionnaire (CSQ; Turner et al., 2002). This questionnaire was adapted to include open questions about cultural acceptability.
Timepoint [2] 336717 0
- Post-intervention only (immediately after the 6 weeks of intervention)

Eligibility
Key inclusion criteria
- Are parents of a 2-12 years old child;
- Parents need to report being concerned about their child's behaviour, assessed during the screening interview.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- The child shows evidence of developmental disorders (e.g., autism) and/or chronic illness, including language and speech impairment;
- The child is currently having regular contact with another professional or agency or taking medication for behavioural problems;
- The parent is currently seeing a professional for parenting support, primarily relating to their child’s behaviour difficulties;
- The parent is receiving psychological/psychiatric help or counselling (personal/marital);
- The parent is intellectually and/or hearing impaired;
- The parent is not able to read/write Portuguese without assistance.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents who express an interest in the study (either by emailing the researchers or calling) will be asked to complete a telephone screening interview designed to assess the family’s suitability for the program as well as to ensure that the families meet the following criteria.
Parents of families who met the inclusion criteria will be asked to read the information sheet and to sign the consent form. Randomization to conditions will be conducted after the participant's completion of pre-intervention measures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible families will be randomly assigned to one of the two groups, an intervention or waitlist control group. Randomization will be implemented using a list of computer generated random numbers, and families will be assigned sequentially to condition according to the list using a series of pre-labelled, sealed opaque envelopes, administered by a research assistant, to ensure that the first researcher is blind to group assignment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To analyse the intervention effects following program completion, and at 6-months follow up, we will use Structural Equation Model (SEM), further, multigroup analyses will be used to compare the outcomes between the Intervention and Control groups. The sample size was determined using pre-established guidelines (Morgan & Van Voorhis, 2007) for statistics designed to detect differences between groups, based on a desire to have a minimum of 80% power (Cohen, 1988).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/07/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 9040 0
Brazil
State/province [1] 9040 0

Funding & Sponsors
Funding source category [1] 296920 0
Government body
Name [1] 296920 0
Brazilian Federal Agency CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior- Coordination for the Improvement of Higher Education Personnel)
Country [1] 296920 0
Brazil
Funding source category [2] 296925 0
University
Name [2] 296925 0
School of Psychology, University of Queensland
Country [2] 296925 0
Australia
Primary sponsor type
Individual
Name
Mariajose Louise Caro Schulz
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 295930 0
None
Name [1] 295930 0
Address [1] 295930 0
Country [1] 295930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298128 0
School of Psychology, Ethics Review Committee
Ethics committee address [1] 298128 0
Ethics committee country [1] 298128 0
Australia
Date submitted for ethics approval [1] 298128 0
Approval date [1] 298128 0
07/06/2017
Ethics approval number [1] 298128 0
17-PSYCH-PHD-31-JMC
Ethics committee name [2] 298131 0
Brazil’s National Committee for Ethics in Research
Ethics committee address [2] 298131 0
Ethics committee country [2] 298131 0
Brazil
Date submitted for ethics approval [2] 298131 0
06/05/2017
Approval date [2] 298131 0
Ethics approval number [2] 298131 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76090 0
Miss Mariajose Louise Caro Schulz
Address 76090 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 76090 0
Australia
Phone 76090 0
+61 4 31042452
Fax 76090 0
Email 76090 0
m.schulz@uq.net.au
Contact person for public queries
Name 76091 0
Mariajose Louise Caro Schulz
Address 76091 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 76091 0
Australia
Phone 76091 0
+61 4 31042452
Fax 76091 0
Email 76091 0
m.schulz@uq.net.au
Contact person for scientific queries
Name 76092 0
Mariajose Louise Caro Schulz
Address 76092 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia
Brisbane QLD 4072
Country 76092 0
Australia
Phone 76092 0
+61 4 31042452
Fax 76092 0
Email 76092 0
m.schulz@uq.net.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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