Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000741886
Ethics application status
Approved
Date submitted
10/07/2012
Date registered
11/07/2012
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating a parenting program for grandparents
Scientific title
Effects of the Triple P-Positive Parenting Program for Grandparents on grandchild behaviour and grandparent depression, anxiety, stress, and confidence with parenting.
Secondary ID [1] 280817 0
Nil
Universal Trial Number (UTN)
U1111-1132-5622
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grandparent parenting style 286875 0
Grandparent depression 286876 0
Grandparent anxiety 286877 0
Grandparent stress 286878 0
Grandparent confidence with parenting 286879 0
Grandparent reported grandchild behaviour problems 286880 0
Grandparent relationship quality with parents 286881 0
Grandparent marital relationship quality 286882 0
Grandparent problems over parenting 286883 0
Parent reported relationship quality with grandparent 286884 0
Parent reported child behaviour problems 286885 0
Condition category
Condition code
Mental Health 287200 287200 0 0
Other mental health disorders
Mental Health 287201 287201 0 0
Depression
Mental Health 287202 287202 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Grandparent Triple P is a nine session program, with one session provided per week. The first 6 sessions are conducted in a group setting with between 4-10 other grandparents in attendance and they are of a two hour duration. The final three sessions are individual telephone consultations with the participants. They are also provided weekly and each phone consultation has between a 20-30 minute duration.

Grandparent Triple P Program Session Details:

Session 1: Positive Grandparenting
We introduce the 6 principles of positive grandparenting and discuss causes of grandchild behaviour. We also develop goals for change.

Session 2: Helping Grandchildren Develop
We discuss the 10 positive strategies to improve grandparent-grandchild relationships.
We also discuss how to apply the strategies of descriptive praise, talk, affection, and setting a good example to the parents.

Session 3: Managing Misbehaviour
Discuss 7 strategies to manage misbehaviour.
We also discuss the stop and start routines.

Session 4: Building a Positive Parenting Team
We discuss expectations of being a grandparent, communication skills, problem solving, and using strategies to manage the emotional distress of parents. We also discuss how to use casual conversations to help share parenting strategies between grandparents and parents.

Session 5: Grandparent Survival Skills
We discuss the unhelpful emotions of stress, anxiety, depression, and anger, and how these emotions can affect the relationship with the parents, your partner, and grandchildren.
We discuss 10 different coping strategies to manage these emotions.

Session 6: Planning Ahead
We discuss how to prepare for high risk situations (e.g., situations with the parents, going shopping, etc)

Session 7 -9: Telephone Calls and Program Close
At this point the practitioner provides ongoing support to the grandparents through telephone calls. This is when the program gets tailored to the individual needs of the grandparent.
The final session can also occur as a group session. In the final session we also discuss how to maintain positive change and looking ahead for further high-risk times.
Intervention code [1] 285243 0
Behaviour
Comparator / control treatment
The control group is a care as usual group. They are permitted to access any other help they would like to during the course of the intervention and follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 287490 0
Grandchild behaviour measued by the Eyberg Child Behavior Inventory
Timepoint [1] 287490 0
Pre intervention, post-intervention, six-month follow-up.
Primary outcome [2] 287491 0
Grandparent depresison, anxiety and stress, measured by the Depresion Anxiety Stress Scale (DASS-21)
Timepoint [2] 287491 0
Pre-intervention, post-intervention, six-month follow-up
Primary outcome [3] 287492 0
Grandparent confidence with parenting measured by the Parenting Tasks Checklist.
Timepoint [3] 287492 0
Pre-intervention, post-intervention, six-month follow-up
Secondary outcome [1] 298281 0
Grandparent relationship quality as measured by the Relationship Quality Index
Timepoint [1] 298281 0
Pre-intervention, post-intervention, six-month follow-up
Secondary outcome [2] 298282 0
Grandparent problems over parenting, measured by the Parenting Problem Checklist
Timepoint [2] 298282 0
Pre-intervention, post-intervention, six-month follow-up

Eligibility
Key inclusion criteria
Grandparent reports concerns over grandchild social, emotional, or behavioural functioning. Or grandparent in the clinical range on either the depression, stress, or anxiety subscale of the DASS at screening phase. Grandparent provides at least 12 hours of care per week to grandchild. The parent consents to the involvement in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Grandparents were excluded if their grandchild had a disability and/or chronic illness, including language and speech impairment; if the grandparents or parents were currently seeing a professional for the child’s behaviour difficulties; if the grandparents were currently receiving psychological help or counselling; or if the grandparents were intellectually disabled and/or hearing impaired.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Grandparents and parents provided informed consent to participate in the study and were randomly assigned after completing assessment to either the intervention or care-as-usual condition. The primary researcher was blind to the assignment of participants to condition, with an independent researcher allocating participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was implemented using a list of computer-generated random numbers and participants were assigned sequentially to condition.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants were stratified based on socio economic background (high vs. low) and relationship to parent (biological vs. in-law).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5504 0
4067
Recruitment postcode(s) [2] 5505 0
4152
Recruitment postcode(s) [3] 5506 0
4272
Recruitment postcode(s) [4] 5507 0
4521
Recruitment postcode(s) [5] 5508 0
4170
Recruitment postcode(s) [6] 5509 0
4069
Recruitment postcode(s) [7] 5510 0
4035
Recruitment postcode(s) [8] 5511 0
4157
Recruitment postcode(s) [9] 5512 0
4210
Recruitment postcode(s) [10] 5513 0
4075
Recruitment postcode(s) [11] 5514 0
4006
Recruitment postcode(s) [12] 5515 0
4061
Recruitment postcode(s) [13] 5516 0
4053
Recruitment postcode(s) [14] 5517 0
4070
Recruitment postcode(s) [15] 5518 0
2485
Recruitment postcode(s) [16] 5519 0
4213
Recruitment postcode(s) [17] 5520 0
4507
Recruitment postcode(s) [18] 5521 0
4511
Recruitment postcode(s) [19] 5522 0
4066
Recruitment postcode(s) [20] 5523 0
4032
Recruitment postcode(s) [21] 5524 0
4019
Recruitment postcode(s) [22] 5525 0
4121
Recruitment postcode(s) [23] 5526 0
4171
Recruitment postcode(s) [24] 5527 0
4034
Recruitment postcode(s) [25] 5528 0
4064
Recruitment postcode(s) [26] 5529 0
4306
Recruitment postcode(s) [27] 5530 0
4011

Funding & Sponsors
Funding source category [1] 285612 0
University
Name [1] 285612 0
The Parenting and Family Support Centre, The University of Queensland
Country [1] 285612 0
Australia
Primary sponsor type
University
Name
The Parenting and Family Sypport Centre, The University of Queensland
Address
The Parenting and Family Support Centre
The School of Psychology
The University of Queensland
St Lucia 4072
Australia
Country
Australia
Secondary sponsor category [1] 284440 0
None
Name [1] 284440 0
Address [1] 284440 0
Country [1] 284440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287610 0
This research was conducted under ethical approval from the University of Queensland Behavioural and Social Sciences Ethical Review Committee in accordance with the standards required by the National Health and Medical Research Council of Australia
Ethics committee address [1] 287610 0
Ethics committee country [1] 287610 0
Australia
Date submitted for ethics approval [1] 287610 0
Approval date [1] 287610 0
10/03/2010
Ethics approval number [1] 287610 0

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

Contacts
Principal investigator
Name 34420 0
Address 34420 0
Country 34420 0
Phone 34420 0
Fax 34420 0
Email 34420 0
Contact person for public queries
Name 17667 0
James Kirby
Address 17667 0
Parenting and Family Support Centre
The School of Psychology
The University of Queensland
St Luica 4072
Australia
Country 17667 0
Australia
Phone 17667 0
+61 7 3346 7689
Fax 17667 0
Email 17667 0
[email protected]
Contact person for scientific queries
Name 8595 0
James Kirby
Address 8595 0
Parenting and Family Support Centre
The School of Psychology
The University of Queensland
St Luica 4072
Australia
Country 8595 0
Australia
Phone 8595 0
+61 7 3346 7689
Fax 8595 0
Email 8595 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.