Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000459527
Ethics application status
Approved
Date submitted
28/04/2015
Date registered
12/05/2015
Date last updated
6/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of a brief parental education program to aid parents' communication with children about sexuality.
Scientific title
A Randomized Controlled Trial evaluating the efficacy of a brief parental education program to aid parents' communication with children about sexuality.
Secondary ID [1] 286575 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadequate parental communication about sexuality with children. 294836 0
Condition category
Condition code
Public Health 295107 295107 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
The intervention aims to increase parental knowledge, skills and confidence in communicating to their child about age appropriate sexuality topics. The Parenting and Family Support Centre (PFSC) at the University of Queensland and Family Planning Queensland (FPQ) have collaborated to develop a brief intervention program to teach parents how to educate their children about sexuality. Contents of the program were guided by the data collected from Morawska and colleagues’ (in press) study, where parents were asked what they would like to see included in a possible intervention to help them teach their children about sexuality. Some topics include, teaching parents what and how to teach children about sexuality, how children learn about sexuality, to be aware of parent traps, the importance of learning about sexuality, responding positively to sexual behaviours, using correct sexual terminology, answering children’s questions about sexuality (e.g. where do babies come from?), and sexuality conversation starters.

The intervention consists of one, 2-hour group discussion, Positive Parenting for Communicating about Sexuality. The content of the sessions draws on the theoretical principles that form the basis of Triple P, and is designed to be interactive and provide opportunities for discussion. The session is designed as an introduction to the principles of positive parenting in the context of parent-child communication about sexuality. It aims to promote positive parenting practices, assist parents to develop effective communication methods and help create environments conducive to caring relationships between parents and their children. Topics covered include (1) Understanding sexuality (2) Being aware of parent traps (3) Responding positively to sexual behaviours (4) Using correct sexuality terminology (5) Answering children’s questions about sexuality (6) Using positive redirections and conversation starters. The discussion groups will be delivered by trained educators at Family Planning Queensland and the Parenting and Family Support Centre at the University of Queensland.


Protocol adherence
Practitioners deliver Triple P according to a standardised manual and follow treatment delivery protocols, and complete protocol adherence checklists for each session conducted. Practitioners will receive regular clinical supervision. Group sessions will be videotaped and independently coded for protocol adherence, using structured session checklists. The inter-rater reliability (kappa) of this coding will be assessed for 25% of videotaped sessions by a second rater.
Intervention code [1] 291691 0
Behaviour
Comparator / control treatment
Control Condition
Families in the control condition will be assessed on entry to the trial, 6 weeks later, and then again at 3 months. After the 3-month follow-up assessment families will be offered participation in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 294868 0
Self-reported effective parenting strategies for child sexual development assessed by self-reported questionnaires (the Parenting Strategies for Child Sexual Development Scale by Morawska, Grabski & Fletcher, 2013).
Timepoint [1] 294868 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Primary outcome [2] 294869 0
Parental self-efficacy relating to communication to children about sexuality assessed by self-reported questionnaires (Parental Self-efficacy about Sexuality Scale, by Morawska, Grabski & Fletcher, 2013).
Timepoint [2] 294869 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Primary outcome [3] 294870 0
Perceived barriers to communication to children about sexuality assessed by self-reported questionnaires (Reasons for Communication about Sexuality Scale, by Morawska, Grabski & Teo).
Timepoint [3] 294870 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Secondary outcome [1] 314261 0
General patterns of Parent-Child Communication assessed by self-reported questionnaires (Parent-Child Communication Scale modified from the revised Family Communication Pattern by Ritchie & Fitzpatrick, 1990).
Timepoint [1] 314261 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Secondary outcome [2] 314334 0
Parental knowledge about child sexuality issues assessed by self-reported questionnaires (Parental Knowledge about Sexuality Scale, Morawska, Grabski & Teo).
Timepoint [2] 314334 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Secondary outcome [3] 314337 0
Parental comfort about communicating about sexuality to children assessed by self-reported questionnaires (Parental Comfort about Sexuality Scale, Morawska, Grabski & Teo).
Timepoint [3] 314337 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Secondary outcome [4] 314338 0
General child behavior assessed by self-reported questionnaires (Child Adjustment and Parent Efficacy Scale by Morawska & Sanders, 2010).
Timepoint [4] 314338 0
Time 2 (4 weeks post-intervention) and Time 3 (3 months post-intervention)
Secondary outcome [5] 314546 0
Observed effective parenting strategies for child sexual development assessed by an observation task (requiring the parent to read two story books to their child) by Morawska, Grabski & Teo).
Timepoint [5] 314546 0
Time 3 (3 months post-intervention)

Eligibility
Key inclusion criteria
1. Presence in the family of a 3-10 year old child
2. The parent is concerned about the child’s sexual development
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Child has been diagnosed with an intellectual disability or a developmental disorder
2. Parent has an intellectual disability or has difficulties in reading a newspaper
3. Child has been sexually abused presently or in the past
4. Parent has been involved in the past 2 years in legal action relating to sexual abuse
5. Child receiving treatment from a counsellor, psychologist or psychiatrist at the moment
6. Parent currently receiving any psychological help or counselling

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)
A pre-prepared series (by a person independent of the research team) of sealed opaque envelopes each labelled with a participant ID number and containing a Randomisation Notification Letter, will be used to conceal the group allocation from both researchers and participants until after completion of the T1 assessment.

Immediately after completion of the T1 observation session the researcher will open the envelope, and participants will be notified of their condition, what this means, what to expect, and what we ask of them. The Randomisation Notification Letter will be provided to the participant to retain for their records.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to either the intervention group or the waitlist control group will be done using a random allocation sequence, generated using a computer-based random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted to determine the required sample size. To detect a medium effect size of .50, with alpha set at .05 and power at .80, a minimum sample size of 58 participants per group is needed. Allowing for potential attrition of 15% the proposed sample size will provide sufficient power to conduct the proposed analyses.
A mixed design Analysis of Variance will be used to evaluate treatment outcomes between the treatment and control group and within the 3 timepoints.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2015
Actual
9/06/2015
Date of last participant enrolment
Anticipated
31/10/2016
Actual
22/07/2016
Date of last data collection
Anticipated
Actual
17/12/2016
Sample size
Target
133
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291143 0
University
Name [1] 291143 0
The University of Queensland
Country [1] 291143 0
Australia
Primary sponsor type
University
Name
The University of Queensland, School of Psychology, Parenting & Family Support Centre
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 289825 0
None
Name [1] 289825 0
Address [1] 289825 0
Country [1] 289825 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292723 0
Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 292723 0
Ethics committee country [1] 292723 0
Australia
Date submitted for ethics approval [1] 292723 0
23/02/2015
Approval date [1] 292723 0
30/03/2015
Ethics approval number [1] 292723 0
2015000268

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

Contacts
Principal investigator
Name 56662 0
Miss Sarah Teo
Address 56662 0
The University of Queensland
School of Psychology
Parenting and Family Support Centre
St Lucia, QLD 4072
Country 56662 0
Australia
Phone 56662 0
+61 4 50525268
Fax 56662 0
Email 56662 0
[email protected]
Contact person for public queries
Name 56663 0
Sarah Teo
Address 56663 0
The University of Queensland
School of Psychology
Parenting and Family Support Centre
St Lucia, QLD 4072
Country 56663 0
Australia
Phone 56663 0
+61 4 50525268
Fax 56663 0
Email 56663 0
[email protected]
Contact person for scientific queries
Name 56664 0
Sarah Teo
Address 56664 0
The University of Queensland
School of Psychology
Parenting and Family Support Centre
St Lucia, QLD 4072
Country 56664 0
Australia
Phone 56664 0
+61 4 50525268
Fax 56664 0
Email 56664 0
[email protected]

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

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