Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000706673
Ethics application status
Approved
Date submitted
13/06/2023
Date registered
3/07/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
3/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring change in parenting programs
Scientific title
Examining the effects of Measurement-Based Care on child externalising behaviours
Secondary ID [1] 309898 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Behavioural disorders 330362 0
Condition category
Condition code
Mental Health 327206 327206 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are parents of children aged between 3 and 9 years 11 months of age who are referred (or self-refer) to the Sydney Child Behaviour Research Clinic, and would like assistance managing child disruptive behaviour. The aim of this study is to conduct a RCT of Measurement-Based Care (MBC; Session-by-session measures plus feedback to parents and clinicians – the intervention group) versus Measurement as Usual (MAU; measures completed pre, post and three-month follow-up – the comparator arm) for improving symptoms of child disruptive behaviour disorders (DBDs) and parent engagement in a behavioural parent training (BPT) intervention provided via telehealth.

Participants who meet inclusion criteria will complete a baseline assessment, which will involve completing online questionnaires and a diagnostic interview with a clinician. Once baseline assessment has been completed, participants will be randomly allocated to the MBC or MAU groups. All families will complete an 8-10 session individually-tailored BPT program.

The BPT intervention is Integrated Family Intervention for Child Conduct Problems (Dadds & Hawes, 2006), a program consisting of 8 to 10 weekly 1 hour treatment sessions focusing on managing child aggression, non-compliance and disruptive behaviour. Parents are empowered to strengthen and develop strategies that encourage positive child behaviour by giving attachment rich positive reinforcement and rewards, and discourage challenging behaviour through the provision of consistent, attachment and emotionally neutral behaviour management strategies. The program also includes modules that address parental mental health, partner support and family communication. It can be individually tailored by adjusting the pace of the intervention depending on rate of change during the program, targeting specific goals for families, covering module content that is relevant for the family (e.g., partner support only for two-parent families). The program will be individual tailored based on clinical formulation and progress during the parenting intervention. Parenting skills will be taught through active skills training via modelling, rehearsal and feedback. For two parent families, both parents (or other key caregivers) are encouraged to attend and participate in all sessions.



Families randomly allocated to the MBC group will complete brief session-by-session measures on child symptoms, functioning, goal attainment, implementation of parenting strategies and therapeutic alliance. These measures will be completed via the NovoPsych platform (novopsych.com.au). The MBC measures are automatically scored with feedback provided to the treating psychologist, who will in turn, share this feedback with the participating parents in order to facilitate tracking of progress in treatment and to prompt collaborative decision making. All but one of the session-by-session measures are completed before the session, with clinicians providing an email reminder to participants. The measure of therapeutic alliance is completed at the end of the session. Participants randomly allocated to the MAU group will not complete these session-by-session measures, but families in both MBC and MAU groups will complete diagnostic and questionnaire measures at pre-, post- and three-month follow-up. The diagnostic and questionnaire measures completed at pre-, post- and three-month follow-up in both groups are different from the session-by-session measures completed in the MBC group, with the exception of one measure, the Pediatric Symptom Checklist-17, which is completed as both a session-by-session measure for the MBC group and as an outcome measure at pre-, post- and three-month follow-up for both groups.

To assess intervention adherence, each session will be video-recorded and coded for adherence to the MBC and MAU groups (time spent providing feedback, discussing progress etc). Clinicians will also complete session-by-session measures to indicate whether they shared feedback and discussed progress with the family.
Intervention code [1] 326319 0
Behaviour
Comparator / control treatment
Parents randomly allocated to the MAU comparator group will not complete session-by-session measures during the BPT. However, they will complete the same 8-10 session BPT intervention as the MBC group and will also complete the same diagnostic and questionnaire measures at pre-, post- and three-month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 335077 0
Child externalising behaviours will be assessed with the Intensity scale of the Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999) completed by all participating parents.
Timepoint [1] 335077 0
The ECBI will be administered at baseline, post-assessment and three-month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Primary outcome [2] 335078 0
Child externalising behaviours will also be assessed by severity of symptoms of oppositional defiant disorder as rated by a blind clinician using the Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP, Tissue et al., 2022).
Timepoint [2] 335078 0
The DISCAP will be administered at baseline, post-assessment and three-month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [1] 422938 0
Child externalising behaviours in the preschool/daycare/school context will be assessed with the Intensity scale of the Sutter-Eyberg Student Behaviour Inventory (SESBI; Eyberg & Pincus, 1990), a teacher-report measure completed by teachers/educators of participating children.
Timepoint [1] 422938 0
The SESBI will be administered at administered at baseline, post-assessment and three month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [2] 422939 0
Child externalising, internalising and Attention Deficit Hyperactivity Disorder (ADHD) symptoms will be assessed by the total score (composite outcome) on the Pediatric Symptom Checklist-17 (Gardner et al., 1999), a parent-report measure that will be completed by all participating parents.
Timepoint [2] 422939 0
The PSC-17 will be administered at baseline, post-assessment and three-month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment. MBC participants will also complete this measure before each session of the BPT
Secondary outcome [3] 422940 0
Clinician ratings of child functioning will be assessed by the Children’s Global Assessment Scale (CGAS; Schaffer et al., 1983), a clinician-rated measure that will be completed based on interview with participating parents.
Timepoint [3] 422940 0
The CGAS will be administered by a blind clinician at baseline, post-assessment and three month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [4] 422941 0
Dysfunctional parenting will be assessed by the total score on the Parenting Scale (PS; Arnold et al., 1993), a parent report measure completed by all participating parents.
Timepoint [4] 422941 0
The PS will be administered at baseline, post-assessment and three-month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [5] 422942 0
Parents’ sense of competence will be assessed by the total score on the Parenting Sense of Competence Scale (PSOC; Johnston & Mash, 1989), a parent-report measure completed by all participating parents.
Timepoint [5] 422942 0
The PSOC will be administered at baseline, post-assessment and three-month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [6] 422943 0
Inter-parental conflict between parents who operate as parenting teams will be assessed with the Intensity scale on the Parent Problem Checklist (PPC; Dadds & Powell, 1991), a parent-report measure completed by all participating parents in two-parent families.
Timepoint [6] 422943 0
The PPC will be administered at baseline, post-assessment and three-month follow-up to parents in two-parent families. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [7] 422944 0
Parental well-being will be assessed using the 10-item version of the Kessler Psychological Distress Scale (K10; Furukawa, Kessler, Slade & Andrews, 2003), a self-report global measure of depressive and anxiety-related symptomology. The K10 will be completed by all participating parents.
Timepoint [7] 422944 0
The K10 will be administered at baseline, post-assessment and three-month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [8] 422945 0
The quality of the therapeutic relationship as rated by parents will be assessed by the Scale to Assess Therapeutic Relationship - parent version (STAR-P; McGuire-Snieckus, 2007), a parent report measure of therapeutic alliance. The STAR-P will be completed by all participating parents.
Timepoint [8] 422945 0
The parent-reported STAR will be administered at baseline, post-assessment and three month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [9] 422946 0
The quality of the therapeutic relationship as rated by clinicians will be assessed by the Scale to Assess Therapeutic Relationship - clinician version (STAR-C; McGuire-Snieckus, 2007), a clinician report measure of therapeutic alliance. The STAR-C will be completed by clinicians for each participating family.
Timepoint [9] 422946 0
The clinician-reported STAR will be administered at baseline, post-assessment and three month follow-up. Post- assessment occurs 8-10 weeks after randomisation (at the completion of the BPT), and three-month follow-up occurs 3 months after post-assessment.
Secondary outcome [10] 422947 0
Satisfaction with the BPT will be assessed by the Client Satisfaction Questionnaire (CSQ; Eyberg, 1993), a parent report measure of therapy satisfaction. The CSQ will be completed by all participating parents.
Timepoint [10] 422947 0
The CSQ will be administered at post-assessment only (at the completion of the BPT).
Secondary outcome [11] 422948 0
Time in BPT will be assessed by total time spent in the program (in minutes). Number of sessions and duration of sessions will be recorded by treating clinician.
Timepoint [11] 422948 0
Time in BPT will be calculated at post-treatment (at the completion of the BPT).
Secondary outcome [12] 422949 0
Drop out from BPT will be assessed by proportion of participants discontinuing from the BPT, which will be assessed via audit of study records.
Timepoint [12] 422949 0
Drop out from BPT will be calculated at the conclusion of the study.

Eligibility
Key inclusion criteria
Inclusion criteria include: 1. Parents/caregivers of children aged 3 to 9 years 11 months; 2. Parents would like assistance in managing their child’s disruptive behaviours; 3. Parents must be able to access high speed internet via computer, tablet, or smart phone to participate in the online parenting program and complete research questionnaires. 4. Parents live in NSW, Australia; 5. Parents are able to attend weekly BPT sessions for 8-10 weeks; 6. For children medicated for behaviour, they must be stable on current dose for 4 weeks, with no planned changes in dosage across the trial period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria are: 1. Child has an intellectual disability, Autism Spectrum Disorder (level 2 or 3), or pervasive developmental disability; 2. Child does not currently live (at least part time) with participating parent; 3. Parent is unable to complete questions and understand program content in English; 4. Family are currently receiving or planning to receive another parenting program or treatment by a psychologist; 5. Family is experiencing domestic violence, child protection issues, or severe parental mental illness/substance use, or is subject to court orders regarding parenting.


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 to treatment condition will be concealed to researchers by using a central randomisation procedure on the trial’s REDCap system: Once participants have completed the baseline assessment, the trial manager will initiate random allocation to the MBC or MAU group using the in-built randomisation feature on REDCap. This procedure will ensure concealment of treatment allocation as well as an audit trail for confirming allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation sequence will be generated using Robust Randomisation App (RRApp; Tu & Benn, 2018), which is an online tool. The sequence will be imported into the trial’s REDCap system.
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 priori power analysis was performed using G*Power software to determine a reasonable sample size for the study. Based on repeated-measures ANOVAs with within-between interactions, two groups, with two primary outcome measures and three measurement time points, a total sample size of 144 (72 per group) is sufficient to detect a small-to-moderate effect size of 0.15, using power = 0.8 and a Type I error rate of 0.05 (consistent with convention).
Clinical significance of change will be calculated by the proportion of participants who decrease from the clinically significant range on the ECBI intensity and DISCAP to non-clinical range at post-assessment and 3 month follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
14/02/2024
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
144
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314082 0
Charities/Societies/Foundations
Name [1] 314082 0
Australian Rotary Health
Country [1] 314082 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 315992 0
None
Name [1] 315992 0
Address [1] 315992 0
Country [1] 315992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313220 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 313220 0
The University of Sydney
Camperdown NSW 2006
Ethics committee country [1] 313220 0
Australia
Date submitted for ethics approval [1] 313220 0
17/04/2023
Approval date [1] 313220 0
06/07/2023
Ethics approval number [1] 313220 0
2023/349

Summary
Brief summary
This primary aim of this study is to examine the effectiveness of Measurement-Based Care (MBC session-by-session measures plus feedback to parents and clinicians) versus Measurement as Usual (MAU) for parents of children aged between 3 and 9 years 11 months of age participating in a 8-10 session BPT, delivered via telehealth. All participating families will complete measures at pre, post and three-month follow-up. Primary outcomes include reduction in severity of children's symptoms of DBDs according to both diagnostic ratings by blind clinicians and parent reports at post-intervention and three- month follow-up. Secondary outcomes include: teacher reports of severity of DBDs; parent satisfaction with treatment; clinician and parent ratings of therapeutic alliance, dysfunctional parenting; parental conflict over parenting; and parental mental health. In addition, clinically significant change in severity of DBDs rated by blind clinicians and parent reports will be calculated and compared across groups. Rates of drop-out from intervention and total time in the program will also be compared across groups.
1. At post-assessment and three-month follow-up, relative to the MAU comparison group, the MBC intervention group will have:

a) significantly lower levels of child symptoms of DBDs (diagnostic ratings and parent reports)
b) significantly lower levels of teacher ratings of DBDs
c) significantly higher parent and clinician ratings of the therapeutic alliance
d) significantly higher levels of clinician ratings of child functioning
e) significantly lower levels of dysfunctional parenting, inter-parental conflict over parenting, and improved parental well-being.
e) significantly higher parent ratings of satisfaction with treatment.

2. Compared to the MAU comparison group, the MBC intervention group will show:

a) significantly high levels of clinically significant change in severity of DBDs (for diagnostic ratings and parent reports) at post and three-month follow-up
b) significantly lower levels of drop out from the intervention
c)significant less time participating in the program overall.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127390 0
Dr Lucy Tully
Address 127390 0
Child Behaviour Research Clinic
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 127390 0
Australia
Phone 127390 0
+61 439723814
Fax 127390 0
Email 127390 0
[email protected]
Contact person for public queries
Name 127391 0
Ms Adrienne Turnell
Address 127391 0
Child Behaviour Research Clinic
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 127391 0
Australia
Phone 127391 0
+61 2 9114 4326
Fax 127391 0
Email 127391 0
[email protected]
Contact person for scientific queries
Name 127392 0
Ms Adrienne Turnell
Address 127392 0
Child Behaviour Research Clinic
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 127392 0
Australia
Phone 127392 0
+61 2 9114 4326
Fax 127392 0
Email 127392 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
IPD will not be available


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.