Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001416280
Ethics application status
Approved
Date submitted
14/08/2018
Date registered
24/08/2018
Date last updated
27/10/2021
Date data sharing statement initially provided
31/07/2019
Date results information initially provided
27/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
BetterBonds: Evaluation of an online attachment-based parenting program
Scientific title
A Randomised Control Trial of an Attachment Based Online Parenting Program
Secondary ID [1] 295802 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attachment disorder 309238 0
Condition category
Condition code
Mental Health 308113 308113 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research will be conducted as part of a wait-list randomised control trial. The intervention consists of 6 online modules with psycho-educational content and an activity to complete. They contain reading material on attachment theory and will also have audio of the written material. These are to be completed individually by parents in their own homes. All the modules will be offered over the space of 3 months before the waitlist control will be able to access the intervention. Participants are encouraged to take time to think about each module ideally completing one module a week but can complete them at a rate that suits them. Each module is designed to take the client's approximately 1 hour. Mary Gregory a Clinical Psychologist has developed the intervention who has over 10 years experience working with adult and child mental health clients. The participants will be parents recruited from Child Health, Child and Youth Mental Health, Playgroup QLD and Child Safety.
Google Analytics (Google Inc, 2016) will be added to the website which will provide diagnostics that can be used to anonymously track the amount of time users spend on the site, the times of day they have accessed the site, how many pages they viewed and how many times they visited the website. This information will provide evidence of treatment receipt by the participants. Treatment enactment will be measured by a Likert scale at the end of each module will measure the intervention on a scale from 1 = I did not attempt the reading to 6 = I completed the reading and then did additional work on this topic. The activity component will be measured in the same way with a scale from 1 = I did not attempt the activity to 6 = I completed the activity and then did additional work on this topic. There will also be the opportunity for participants to provide feedback as to whether they understood or enjoyed the topics discussed in the module.
Intervention code [1] 312135 0
Behaviour
Comparator / control treatment
There is a waitlist control who will complete the psychometrics at the same time as the treatment condition but will only be able to access the intervention after 3 months.
Control group
Active

Outcomes
Primary outcome [1] 307090 0
Portion of the participants with a change in parental acceptance as assessed by the Parent Acceptance-Rejection Questionnaire.
Timepoint [1] 307090 0
After 3 months
Primary outcome [2] 307144 0
Portion of the participants with a change in their report of their reflective functioning as assessed by the Reflective Functioning Questionnaire
Timepoint [2] 307144 0
After 3 months
Primary outcome [3] 307179 0
Portion of the participants with a change in their report ed childs' strengths as assessed by the Strengths and Difficulties Questionnaire.
Timepoint [3] 307179 0
After 3 months
Secondary outcome [1] 350657 0
Portion of the participants with a change in their report of their child's difficulties as assessed by the Strengths and Difficulties Questionnaire.
Timepoint [1] 350657 0
3 months
Secondary outcome [2] 351000 0
Portion of the participants with a change in their parental rejection as assessed by the Parent Acceptance-Rejection Questionnaire
Timepoint [2] 351000 0
After 3 months
Secondary outcome [3] 351001 0
Portion of the participants with a changein their parental stress as assessed by the Parental Stress Scale.
Timepoint [3] 351001 0
After 3 months

Eligibility
Key inclusion criteria
Any parent or foster carer involved with Playgroup QLD (Queensland), Child Health (Sunshine Coast Hospital District), Child and Youth Mental Health (Sunshine Coast Hospital District), or Child Safety (Moreton Region) with a child aged over 2 years of age. They will need internet access, to be able to read and write basic English and be over the age of 18 years to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents not involved with one of the services listed above. Parents under 18 years of age or those who are unable to read and write basic English. No access to internet at home and no ability to access the free internet available at the public libraries in QLD.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. The participants will be told they are on the waitlist for the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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
An a priori power analysis indicated that each group would need 50 participants with 25 in the treatment group and 25 in the wait list control group which would allow a significance level of 0.05 when calculating Cohen’s d.Cohen’s d will be used to compare the means of the measures for each group to assess whether there have been significant changes on the measures after the intervention. This analysis was based on 80% power (1-ß err prob) to detect the smallest clinically significant change to be identified by a mixed ANOVA (repeated measures, within-between interaction), with an alpha (a) of .005, which has been adjusted for multiple comparisons. If the data has severe sphericity issues, a non-parametric option will be used instead, so a non-sphericity correction is not necessary at this point. An extensive review of literature was completed looking at attrition rates for different populations which were then calculated in to the participant numbers. 20% top out rates were calculated for all the populations except the Child Safety parents. Due to the higher number of risk factors for this group a 40% attrition rate was calculated.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
It was PhD research so there were time constraints on data collection and analysis
Date of first participant enrolment
Anticipated
1/11/2018
Actual
13/10/2018
Date of last participant enrolment
Anticipated
Actual
1/09/2019
Date of last data collection
Anticipated
Actual
1/11/2019
Sample size
Target
276
Accrual to date
Final
185
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 11664 0
University of Sunshine Coast Health Clinics - Sippy Downs
Recruitment postcode(s) [1] 23710 0
4556 - Sippy Downs

Funding & Sponsors
Funding source category [1] 300396 0
University
Name [1] 300396 0
University of Sunshine Coast
Country [1] 300396 0
Australia
Primary sponsor type
Hospital
Name
University of the Sunshine Coast
Address
Thompson Institute (ML59), University of the Sunshine Coast
Locked Bag 4 MAROOCHYDORE DC QLD 4558
Country
Australia
Secondary sponsor category [1] 299854 0
None
Name [1] 299854 0
Address [1] 299854 0
Country [1] 299854 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301204 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 301204 0
PO Box 670
Townsville Qld 4810
Ethics committee country [1] 301204 0
Australia
Date submitted for ethics approval [1] 301204 0
14/03/2018
Approval date [1] 301204 0
07/08/2018
Ethics approval number [1] 301204 0
HREC/18/QTHS/77

Summary
Brief summary
The bond that develops between an infant and their caregiver shapes their developing brain and provides the framework through which they see themselves, others, and the world. Attachment theory provides a structure in which to understand this unique and important relationship. Research has shown that having a secure attachment provides resilience against adverse experiences while a poor attachment can lead to mental health problems and relational difficulties. Therapeutic interventions have been developed, which have been shown to be effective in helping caregiver­child dyads develop a secure attachment. However there is a need for these types of interventions to be less intensive and targeted at modifying the caregiver’s internal working models to increase sensitivity. This research proposes that modification can be done with psycho­education and increasing the caregivers reflective functioning. This research project proposes an attachment­based intervention using education and increasing the caregivers reflective functioning can be effective. Conducting the intervention using an internet based format will provide easily accessible and cost­effective means of helping parents and caregivers
Trial website
www.BetterBonds.com.au
Trial related presentations / publications
None yet
Public notes

Contacts
Principal investigator
Name 86210 0
Ms Mary Gregory
Address 86210 0
Thompson Institute (ML59), University of the Sunshine Coast
Locked Bag 4 MAROOCHYDORE DC QLD 4558
Country 86210 0
Australia
Phone 86210 0
+61 420741938
Fax 86210 0
Email 86210 0
[email protected]
Contact person for public queries
Name 86211 0
Ms Mary Gregory
Address 86211 0
Thompson Institute (ML59), University of the Sunshine Coast
Locked Bag 4 MAROOCHYDORE DC QLD 4558
Country 86211 0
Australia
Phone 86211 0
+61 420741938
Fax 86211 0
Email 86211 0
[email protected]
Contact person for scientific queries
Name 86212 0
Ms Mary Gregory
Address 86212 0
Thompson Institute (ML59), University of the Sunshine Coast
Locked Bag 4 MAROOCHYDORE DC QLD 4558
Country 86212 0
Australia
Phone 86212 0
+61 420741938
Fax 86212 0
Email 86212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The informed consent was only for this study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3458Informed consent form https://betterbonds.com.au/informed-consent/  https://www.BetterBonds.com.au
3519Study protocol https://betterbonds.com.au/researchprocess/ 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gregory, M., Kannis-Dymand, L., & Sharman, R. A re... [More Details] 375788-(Uploaded-15-10-2021-17-28-06)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.