Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000878875
Ethics application status
Approved
Date submitted
14/08/2012
Date registered
20/08/2012
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Incredible Years Specialist Service (IYSS) – An evaluation of the efficacy of adding a manualised enhancement service to improve outcomes for high-risk families/whanau attending the Incredible Years Parent Programme (IYP).
Scientific title
Do parents of children ages 3-7 years who are attending an Incredible Years Parent programme (IYP) have better outcomes by having extra in home support service to help implement new parenting strategies compared to those who just attend Incredible Years Parent programme (IYP).
Secondary ID [1] 281059 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child conduct problems 287201 0
Condition category
Condition code
Mental Health 287530 287530 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive 10 in home coaching sessions while they attend a 14-18 week Incredible Years Parent Programme (IYP) to help personalise the parenting strategies and implement them in the home. The Incredible Years programme is carried out in groups of 10-16 participants for 2.5 hours weekly for 14-18 weeks. Each week a parenting strategy is covered. Parents learn together by reflecting on their implementation of new strategies, discussing key points, watching video examples, practicing new skills, and setting a goal for the next week. The number of IYP sessions is determined by the programme i.e Pre-school IYP is 16-18 sessions and School-Age IYP is 14-16 sessions. Facilitators are able to extend the number of sessions depending on the needs of the group. The in-home coaching is for an hour once a week in the participant’s home and supports the learning from the group sessions. It is one-on-one sessions but may also include other key family/whanau members and/or the children. The coaching involves reviewing the content of the last IYP session, practicing new skills, addressing any barriers, and setting specific goals.
Intervention code [1] 285468 0
Treatment: Other
Intervention code [2] 285469 0
Behaviour
Comparator / control treatment
A randomised controlled trial. Eligible participants will come from up to 16 IYP groups delivered in the community by Ministry of Health, Non Government Agencies (NGO's) and Ministry of Education. All IYP programmes are delivered according to the manualised protocol by trained facilitators. Groups are delivered in different locations within the region, on different days of the week and different times (evening and daytime) to allow for maximum access.
Eligible participants will be randomly allocated to the treatment arm to receive additional in home coaching from the Incredible Years Specialist Service (IYSS) at the same time as attending the IYP group, or to the control group of IYP treatment with no additional intervention. Randomisatin will be stratified on each IYP group so that there are equal numbers in each arm of treatment. There will be one treatment group and one control group for this study.
Control group
Active

Outcomes
Primary outcome [1] 287733 0
The primary aim of this evaluation is to collect data on the efficacy of the addition of IYSS as a structured home intervention, and thereby to test the feasibility of undertaking a larger prospective RCT trial and to inform power calculations for such a trial. The primary outcome: is the change in the parent/whanau scores on the total problem scale in the Eyberg Child Behavior Inventory (ECBI).
Timepoint [1] 287733 0
Time point: Pre-treatment, post-treatment and six month follow-up.
Secondary outcome [1] 298730 0
Secondary outcome 1: The percentage of parent/whanau scores on the ECBI and the SCS that are in the normal range.
Timepoint [1] 298730 0
Time Point: Post-treatment and six month follow-up.
Secondary outcome [2] 298731 0
Secondary outcome 2: Changes from pre to post intervention in child behaviour, parenting practices, parent relationships and parental well being as measured by the Family Questionnaire (FQ) scales.
Timepoint [2] 298731 0
Time Point: Pre-treatment, post-treatment and six month follow-up.
Secondary outcome [3] 298732 0
Secondary outcome 3: The percentage of participants with at least 80% engagement in IYP as measured by the attendance register for the IYP group
Timepoint [3] 298732 0
Time Point: post-treatment
Secondary outcome [4] 298733 0
Secondary outcome 4: Parent/whanau qualitative reports of competence with implementing IYP strategies in the home as measured by the follow-up questionnaire
Timepoint [4] 298733 0
Time Point: six month follow-up
Secondary outcome [5] 298734 0
Secondary outcome 5: Maintenance of improvement at 6 month follow-up as measured by the Family Questionnaire and the follow-up questionnaire
Timepoint [5] 298734 0
Time Point: Point:six month follow-up
Secondary outcome [6] 298735 0
Secondary outcome 6: High levels of parent/whanau satisfaction with IYSS as measured in the follow-up questionnaire
Timepoint [6] 298735 0
Time Point: Six month post-treatment follow-up.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion in the trial if: -They are attending an IY programme. -Their child is over 3 years and under 8 years of age on the date of consent. -Parent/whanau Child Behaviour Scores are in the clinical range i.e. Eyberg Child Behaviour Inventory (ECBI) Intensity scale greater then 127, Problem scale greater than 11, OR Scores on Social Competence Scale (SCS) below 17. - Or one of the following risk factors is present: CYFS involvement, School exclusion Parent/whanau diagnosed with mental health disorder - They sign informed consent to participate in the trial.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

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)
On completion of baseline data, participants will be randomised to IYP and IYSS or IYP alone. The randomisation will be undertaken using a computer generated randomisation sequence generated prior to the enrolment of any participants. The randomisation sequence will have a 1:1 ratio to the two treatments arranged in permuted blocks. After participants have met all inclusion criteria and signed the informed consent they will be allocated a study number. Study numbers will be submitted to a universtiy statisician who will allocate the next available randomisation allocation. The randomisation list will not be available to the primary investigator or to any researchers directly involved in the assessment or screening of participants. Randomisation will be stratified on age (under 5years and over 5 years,) sex, and ethnicity (Maori and non Maori), for each intervention group so that each intake or source group will have approximately equal numbers allocated to each treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be determined via a computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2013
Actual
5/02/2013
Date of last participant enrolment
Anticipated
Actual
10/02/2014
Date of last data collection
Anticipated
Actual
20/06/2015
Sample size
Target
100
Accrual to date
Final
126
Recruitment outside Australia
Country [1] 4483 0
New Zealand
State/province [1] 4483 0

Funding & Sponsors
Funding source category [1] 285796 0
Government body
Name [1] 285796 0
New Zealand Ministry Of Health
Country [1] 285796 0
New Zealand
Primary sponsor type
Individual
Name
Dianne Lees
Address
3 Pendennis Cres
Tauranga 3110
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284663 0
University
Name [1] 284663 0
Auckland University
Address [1] 284663 0
Department of Psychological Medicine
Private Bag 92019
Auckland 1142
Country [1] 284663 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287809 0
Northern Regional Y Ethics Committee New Zealand
Ethics committee address [1] 287809 0
Ethics committee country [1] 287809 0
New Zealand
Date submitted for ethics approval [1] 287809 0
26/06/2012
Approval date [1] 287809 0
06/09/2012
Ethics approval number [1] 287809 0
NTY12/06/050
Ethics committee name [2] 287996 0
Northern B Health and Disability Ethics Committee
Ethics committee address [2] 287996 0
Ethics committee country [2] 287996 0
New Zealand
Date submitted for ethics approval [2] 287996 0
20/08/2012
Approval date [2] 287996 0
06/09/2012
Ethics approval number [2] 287996 0
NTY/12/06/050

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

Contacts
Principal investigator
Name 34565 0
Ms Dianne Lees
Address 34565 0
3 Pendennis Cres
Tauranga 3110
New Zealand
Country 34565 0
New Zealand
Phone 34565 0
+6421816791
Fax 34565 0
+6475787961
Email 34565 0
leesdianne@gmail.com
Contact person for public queries
Name 17812 0
Dianne Lees
Address 17812 0
3 Pendennis Cres
Tauranga 3110
New Zealand
Country 17812 0
New Zealand
Phone 17812 0
+6421816791
Fax 17812 0
+64 75787961
Email 17812 0
leesdianne@gmail.com
Contact person for scientific queries
Name 8740 0
Dianne Lees
Address 8740 0
3 Pendennis Cres
Tauranga 3110
New Zealand
Country 8740 0
New Zealand
Phone 8740 0
+6421816791
Fax 8740 0
+64 75787961
Email 8740 0
leesdianne@gmail.com

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.