Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001523392
Ethics application status
Approved
Date submitted
3/10/2017
Date registered
1/11/2017
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Exploring Together program for primary school children with behavioural and emotional problems.
Scientific title
Evaluation of the Exploring Together program: a cluster-randomised trial for primary school aged children with behavioural and emotional problems.
Secondary ID [1] 292790 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
child externalising behaviours 304599 0
child internalising behaviours
 304600 0
Condition category
Condition code
Mental Health 303925 303925 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two versions of the early primary school version of the Exploring Together program were evaluated; one form had separate child and parent group sessions (Exploring Together-Adapted; ET-Adapted) and the other form included some parent-child group time in the intervention (Exploring Together; ET).

The Exploring Together program (Littlefield et al., 2010) is a multi-group treatment program in that it involves children, their parent, and teachers. The original manualized version of the program consists of three group components, namely parent-child interactive groups, children’s group, and parent’s group. Additionally, two teacher’s meetings and two partner’s meetings are held throughout the program. The theoretical underpinning of the program is drawn from a number of psychological theories, including, cognitive-behavioral theory, attachment theory, and coercion theory. The program focuses on supporting parents, enhancing parenting practices, strengthening family units, reducing children’s problematic behavior, and developing children’s social skills.

The ET-Adapted program consisted of separate concurrent groups for children (1.5 hours, 2 leaders) and parents (1.5 hours, 2 leaders). The ET program consisted of a parent-child interactive group (40 minutes, 4 leaders), followed by separate concurrent group sessions for parents and children (each 1 hour duration with 2 group leaders). Parents and children then came together for a final parent-child interactive group (20 minutes, 4 leaders).

The programs were provided free to participants and consisted of nine (weekly) sessions, coinciding with school terms. It was a requirement that one parent be able to attend the nine-week group program. Intervention groups were conducted at the participating primary school during school hours. Each version of the program consisted of all of the content covered in the original manualized version of the early primary school edition of the Exploring Together program (Littlefield et al., 2010), including the distribution of weekly Mystery Mission (homework) tasks.

Both versions of the program included two meetings for partners or support persons and two meetings for teachers. Additionally, both versions of the program incorporated teaching of Emotion Coaching principles (Gottman & DeClaire, 1997) to parents throughout the program. Parent participants from both intervention conditions were invited to attend a booster group to coincide with 6-month follow-up.

Two teachers meetings (each 1-1.5 hours in duration) were held throughout both versions of the program (ET and ET-Adapted) and were usually held at the end of a school day. The teachers meetings aimed to provide information about the program and promote a consistent approach in how to discipline and nurture the children.

Two group-based, face-to-face parent evenings (each 1-1.5 hours in duration) were held throughout both versions of the program (ET and ET-Adapted). The parent evenings aimed to elicit the partner’s expectations of the program and to involve the partners in the program and implementing strategies in the home.

Parent participants from both versions of the program (ET and ET-Adapted) were invited to attend a group booster session (1-1.5 hours long) to coincide with completion of 6-month follow-up measures. The aims were to complete the 6-month follow-up measures and reinforce parenting strategies learnt during the program, and provide an opportunity to troubleshoot any problems that may have arisen.

Monash Health mental health clinicians who completed a 2-day training workshop with the Exploring Together program authors or who were trained through co-leading a group with a trained Monash Health clinician led the groups.

The clinicians completed fidelity checklists throughout the intervention period for a subsample of groups (16%) in order to elicit information about therapist adherence to group set-up and process.

Gottman, J.M., & DeClaire, J. (1997). The heart of parenting: How to raise an emotionally
intelligent child. London: Bloomsbury.

Littlefield, L., Story, K., Woolcock, C., Trinder, M., Burke, S., & Reid, K. (2010). Exploring
Together Preschool/Early Primary School Program: Program Manual. Princes Hill, Victoria: Exploring Together.
Intervention code [1] 299033 0
Treatment: Other
Intervention code [2] 299034 0
Prevention
Intervention code [3] 299036 0
Behaviour
Comparator / control treatment
The ET program consisted of a combined parent-child dyad interactive group session (40 minutes, 4 leaders), followed by separate concurrent group sessions for parents and children (each 1 hour duration with 2 group leaders). Parents and children then came together for a final interactive group session (20 minutes, 4 leaders).

Both versions of the program were provided free to participants and were delivered weekly for nine weeks.
Control group
Active

Outcomes
Primary outcome [1] 303264 0
Child Behaviour Checklist (CBCL) (parent report)
Timepoint [1] 303264 0
Baseline, post intervention (primary timepoint), and 6- and 12-month follow-ups.
Primary outcome [2] 303265 0
Child Behaviour Checklist (CBCL) (teacher report)
Timepoint [2] 303265 0
Baseline, post intervention (primary timepoint) , and 6- and 12-month follow-ups
Secondary outcome [1] 338475 0
Alabama Parenting Questionnaire (APQ) negative/positive parenting behaviours
Timepoint [1] 338475 0
Baseline, post intervention, 6- and 12-month follow-ups
Secondary outcome [2] 338478 0
Parenting Sense of Competence (PSOC): self-efficacy and satisfaction scales
Timepoint [2] 338478 0
Baseline, post intervention, 6- and 12-month follow-ups
Secondary outcome [3] 338480 0
Parenting Stress Index - Short Form (PSI-SF): total stress index score
Timepoint [3] 338480 0
Baseline, post intervention, 6- and 12-month follow-ups
Secondary outcome [4] 339314 0
Parent and Family Adjustment Scales (PAFAS)
Timepoint [4] 339314 0
Baseline, post intervention, 6- and 12-month follow-ups

Eligibility
Key inclusion criteria
Participants were children in Preparatory year to Grade Three with externalising and/or internalising behaviour problems and their parent/carer, recruited from consenting government and catholic primary schools in the south east metropolitan suburbs of Melbourne and Mornington Peninsula region, Victoria.

Identification of externalising and/or internalising problems occurred through a population wide screening of children in Preparatory year to Grade Three at each participating school using Parent and Teacher versions of the Strengths & Difficulties Questionnaire (SDQ; Goodman, 1997).

Children in Preparatory year to Grade Three were eligible for possible participation in the intervention group based on Parent and/or Teacher SDQ Total Difficulties Score in the borderline – abnormal range (greater than or equal to 14 or 12 respectively). Children were also eligible for the intervention group if they scored in the borderline – abnormal range on an Externalising score (combined Conduct Problems Score, Hyperactivity Score, & Peer Problems Score) of the Parent and/or Teacher SDQ (greater than or equal to 12 or 13 respectively), or if they scored in the borderline – abnormal range on an Internalising score (Emotional Symptoms Score) of the Parent and/or Teacher SDQ (greater than or equal to 4 or 5 respectively).

Goodman, R. (1997). The Strengths and Difficulties Questionnaire: A research note. Journal
of Child Psychology and Psychiatry and Allied Disciplines, 38(5), 581-586.
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent-child dyads excluded on the basis of: parent factors (i.e. unable to attend any or significant part of intervention program; recent or current significant transition or adjustment; significant mental health problems; intellectual disability; and insufficient English for group participation), and/or family factors (i.e. currently engaged in another group parenting program; active child protection case management). Children excluded if they had a pre-existing diagnosis of Autism Spectrum Disorder, intellectual disability, or behaviour disorder of such severity that it required government-funded specialist education support (Department of Education and Early Childhood Development, 1998). Children were also excluded for participation in the intervention group if they required prompt referral for assessment or treatment.

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)
Central randomisation of schools by computer was conducted for allocation to group program (ET or ET-Adapted) at the school level. Schools were randomly allocated to an intervention group prior to the commencement of participant recruitment, hence allocation was not concealed from each parent/child dyad.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent research officer used computer-generated numbers to randomly assign consenting schools to either the ET or ET-Adapted program.
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
All analyses were carried out on an ‘intention to treat’ basis (i.e. all cases were analysed irrespective of number of sessions completed). Because of the multi-stage sampling strategy (schools recruited, then children), multilevel model analyses were conducted to assess the impact of treatment condition (ET, ET-Adapted) from baseline to 12-month follow-up on child outcome variables, taking into account the random effect of school. The main analysis was conducted using Mixed Linear Models (MLM) with SPSS 23. For the main analysis, a MLM was fit with intercept and school as random effects and repeated effect of time for children nested in schools. Key variables (i.e., intervention and time) were added to the model as fixed effects.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
5/04/2011
Date of last participant enrolment
Anticipated
Actual
19/09/2014
Date of last data collection
Anticipated
Actual
18/12/2015
Sample size
Target
240
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8938 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 17309 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 297422 0
Government body
Name [1] 297422 0
Department of Health and Human Services
Country [1] 297422 0
Australia
Primary sponsor type
University
Name
Centre for Developmental Psychiatry & Psychology, Monash University
Address
1/270 Ferntree Gully Road, Notting Hill, VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 296415 0
Hospital
Name [1] 296415 0
Monash Health Early in Life Mental Health Program (primary site Monash Medical Centre)
Address [1] 296415 0
246 Clayton Road, Clayton, Victoria, 3168
Country [1] 296415 0
Australia
Other collaborator category [1] 279701 0
Government body
Name [1] 279701 0
Department of Education and Training Victoria
Address [1] 279701 0
2 Treasury Place, East Melbourne, Victoria, 3002
Country [1] 279701 0
Australia
Other collaborator category [2] 279702 0
Other
Name [2] 279702 0
Catholic Education Melbourne
Address [2] 279702 0
228 Victoria Parade, East Melbourne, Victoria, 3002
Country [2] 279702 0
Australia
Other collaborator category [3] 279778 0
Individual
Name [3] 279778 0
Dr. Glenn A Melvin
Address [3] 279778 0
Centre for Developmental Psychiatry & Psychology, Early in Life Mental Health Service, Monash Medical Centre, 246 Clayton Road, Clayton, 3146.
Country [3] 279778 0
Australia
Other collaborator category [4] 279781 0
Individual
Name [4] 279781 0
Associate Professor Michael Gordon
Address [4] 279781 0
Centre for Developmental Psychiatry & Psychology, Early in Life Mental Health Service, Monash Medical Centre, 246 Clayton Road, Clayton, 3146.
Country [4] 279781 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298528 0
Monash Health Human Research Committee
Ethics committee address [1] 298528 0
Ethics committee country [1] 298528 0
Australia
Date submitted for ethics approval [1] 298528 0
23/11/2010
Approval date [1] 298528 0
21/12/2010
Ethics approval number [1] 298528 0
10342A
Ethics committee name [2] 298531 0
Department of Education and Training
Ethics committee address [2] 298531 0
Ethics committee country [2] 298531 0
Australia
Date submitted for ethics approval [2] 298531 0
14/02/2011
Approval date [2] 298531 0
08/04/2011
Ethics approval number [2] 298531 0
2011_000989
Ethics committee name [3] 298532 0
Catholic Education Melbourne
Ethics committee address [3] 298532 0
Ethics committee country [3] 298532 0
Australia
Date submitted for ethics approval [3] 298532 0
04/02/2011
Approval date [3] 298532 0
10/02/2011
Ethics approval number [3] 298532 0
Project # 1680
Ethics committee name [4] 298533 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [4] 298533 0
Ethics committee country [4] 298533 0
Australia
Date submitted for ethics approval [4] 298533 0
18/03/2014
Approval date [4] 298533 0
07/04/2014
Ethics approval number [4] 298533 0
CF14/926 - 2014000369

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

Contacts
Principal investigator
Name 77366 0
A/Prof Kylie Gray
Address 77366 0
Centre for Developmental Psychiatry & Psychology, Early in Life Mental Health Service, Monash Medical Centre, 246 Clayton Road, Clayton, 3146.
Country 77366 0
Australia
Phone 77366 0
+61 3 9594 1300
Fax 77366 0
Email 77366 0
[email protected]
Contact person for public queries
Name 77367 0
Kylie Gray
Address 77367 0
Centre for Developmental Psychiatry & Psychology, Early in Life Mental Health Service, Monash Medical Centre, 246 Clayton Road, Clayton, 3146.

Country 77367 0
Australia
Phone 77367 0
+61 3 9594 1300
Fax 77367 0
Email 77367 0
[email protected]
Contact person for scientific queries
Name 77368 0
Kylie Gray
Address 77368 0
Centre for Developmental Psychiatry & Psychology, Early in Life Mental Health Service, Monash Medical Centre, 246 Clayton Road, Clayton, 3146.

Country 77368 0
Australia
Phone 77368 0
+61 3 9594 1300
Fax 77368 0
Email 77368 0
[email protected]

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No Supporting Document Provided



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