Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000084189
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
21/01/2019
Date last updated
9/06/2022
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychological Intervention for Childhood Emotional and Behavioural Problems
Scientific title
A Randomised Controlled Trial Evaluating the Efficacy of an Attachment-Based Family Intervention for Childhood Mental Health Symptomatology
Secondary ID [1] 297119 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood mental health symptomatology 311138 0
Condition category
Condition code
Mental Health 309764 309764 0 0
Anxiety
Mental Health 309765 309765 0 0
Depression
Mental Health 309766 309766 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Attachment-Based Family Therapy (AFT) designed to target emotional and behavioural difficulties in middle-aged children. This intervention is based on attachment, psychodynamic, and family systems theory. It aims to shift problematic attachment processes thereby enhancing attachment relationships within the family, and in turn reduce child symptomatology. The intervention will be individualised through an initial interview assessment tool where problematic attachment processes occurring within family members can be identified. This treatment model expands on an existing attachment-focused family-based intervention designed for adolescent substance use and depression (Poole et al., 2016). In the trial AFT will be delivered by provisional psychologists (undertaking postgraduate qualifications) with a minimum of two days training provided by the research team. The treatment requires the whole family to attend for six 90-minute face-to-face sessions over six consecutive weeks. The current trial will be the first piloting of AFT at the Murdoch University Psychology Clinic in Perth, Western Australia. All sessions will be recorded within the trial to allow for randomised fidelity to treatment checks conducted by members of the research team using a standardised assessment tool.
Intervention code [1] 313385 0
Treatment: Other
Intervention code [2] 313386 0
Behaviour
Comparator / control treatment
In this trial, AFT will be compared to treatment as usual at Murdoch University Psychology Clinic, which is largely grounded in established cognitive-behavioural therapy (CBT) principles. This treatment will not be standardised and will be dependent on the provisional psychologist delivering the intervention and their clinical supervisor. This treatment requires postgraduate training and specific training in CBT provided by the course. The trial will require children to attend for face-to-face sessions comparable to the experimental intervention - six 90-minute sessions over six consecutive weeks. Whether or not parents will attend for sessions will vary depending on the provisional psychologist which the child is allocated to.
Control group
Active

Outcomes
Primary outcome [1] 318728 0
Internalising symptoms score measured by the Child Behavior Checklist (Achenbach, 1991)
Timepoint [1] 318728 0
At baseline, pre-treatment (2 weeks), mid-treatment (4 weeks), post-treatment (7 weeks), and four weeks follow-up (11 weeks - primary endpoint).
Primary outcome [2] 318741 0
Externalising symptoms scores measured by the Child Behavior Checklist (Achenbach, 1991)
Timepoint [2] 318741 0
At baseline, pre-treatment (2 weeks), mid-treatment (4 weeks), post-treatment (7 weeks), and four weeks follow-up (11 weeks - primary endpoint).
Secondary outcome [1] 365834 0
Reflective functioning capacity in parents, measured by the Reflective Functioning Questionnaire (Fonagy et al., 2016)
Timepoint [1] 365834 0
At baseline, pre-treatment (2 weeks), mid-treatment (4 weeks), post-treatment (7 weeks), and four weeks follow-up (11 weeks).
Secondary outcome [2] 365835 0
Parent helplessness as measured by the Caregiver Helplessness Questionnaire (George & Solomon, 2011).
Timepoint [2] 365835 0
At baseline, post-treatment (7 weeks) and follow-up (11 weeks).
Secondary outcome [3] 365836 0
Parent mental health as measured by the Depression Anxiety and Stress Scales, 21-item (Lovibond & Lovibond, 1995).
Timepoint [3] 365836 0
At baseline, pre-treatment (2 weeks), mid-treatment (4 weeks), post-treatment (7 weeks), and four weeks follow-up (11 weeks).
Secondary outcome [4] 365837 0
General family functioning, as measured by the McMaster Family Assessment Device (Epstein, Baldwin, & Bishop, 1983).
Timepoint [4] 365837 0
At baseline, post-treatment (7 weeks), and four weeks follow-up (11 weeks).

Eligibility
Key inclusion criteria
- The families of children aged between 6 – 12 years of age
- The child’s scores on the Child Behavior Checklist, rated by their primary caregiver must be above the clinical cut-off point on at least one of the internalising or externalising problem subscales, to indicate clinically significant problematic behaviour(s).
- A ‘family’ must be composed of at least one primary caregiver and the child of interest. There are no exclusions with regard to blended families or other family structures beyond the nuclear family.
- Must be able to communicate adequately in English
Minimum age
0 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Children with the following diagnoses: autism spectrum disorder, intellectual disability, psychosis or psychotic disorders, or any severe mental illness currently requiring inpatient treatment.
- Caregivers or siblings with reports of any of the above psychiatric disorders, in addition to mania, hypomania, or drug dependence other than alcohol, nicotine or cannabis use.
- Any of the family members must not be receiving any other therapeutic interventions at the time of recruitment.

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)
Sealed opaque envelopes will be utilised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block random allocation sequence with a block size of 6 will be utilised, using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was determined using G*Power software, through a sensitivity power analysis, where a total sample size of 32, alpha of 0.05 and power of 0.80, was calculated as sufficient to detect an effect size of 0.60. This number also takes into account variance of repeated measurements and correlation pattern (Guo, 2013), in addition to an estimated attrition rate of 20% (Lewis et al., 2013).

The analysis of data will be primarily quantitative, utilising the latest version of the Statistical Package for Social Science (SPSS).

A general linear mixed model analysis will be used to examine the longitudinal effect of treatment group on outcome measures, and the treatment type by time interaction. The model will assume fixed effects and random intercepts, while controlling for therapist pair to account for any therapist effect. An autoregressive (order 1) covariance matrix will be used to account for repeated observations nested within participants. A two-way interaction between treatment group and time will represent overall treatment outcome, assessing any significant differences between treatment outcome at follow-up. Effect sizes will be calculated for repeated measures, within-group changes using Morris and Deshon’s (2002) eq. 8 calculator, adopting Cohen’s (1992) definitions of effect sizes as small (d = 0.20), moderate (d = 0.50), and large (d = 0.80). Missing data will be included through imputation method of last observation carried forward.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2019
Actual
27/03/2019
Date of last participant enrolment
Anticipated
2/12/2019
Actual
8/09/2020
Date of last data collection
Anticipated
28/02/2020
Actual
2/11/2020
Sample size
Target
32
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 25415 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 301681 0
University
Name [1] 301681 0
Murdoch University
Country [1] 301681 0
Australia
Primary sponsor type
Individual
Name
Irene Serfaty
Address
School of Psychology & Exercise Science,
Murdoch University,
90 South Street, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 301400 0
Individual
Name [1] 301400 0
Andrew Lewis
Address [1] 301400 0
School of Psychology & Exercise Science,
Murdoch University,
90 South Street, Murdoch WA 6150
Country [1] 301400 0
Australia
Secondary sponsor category [2] 301402 0
Individual
Name [2] 301402 0
Renita Almeida
Address [2] 301402 0
School of Psychology & Exercise Science,
Murdoch University,
90 South Street, Murdoch WA 6150
Country [2] 301402 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302401 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 302401 0
Ethics committee country [1] 302401 0
Australia
Date submitted for ethics approval [1] 302401 0
17/01/2019
Approval date [1] 302401 0
25/02/2019
Ethics approval number [1] 302401 0
Project number 2019/008

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

Contacts
Principal investigator
Name 90110 0
A/Prof Andrew Lewis
Address 90110 0
School of Psychology & Exercise Science,
Murdoch University,
90 South Street, Murdoch WA 6150
Country 90110 0
Australia
Phone 90110 0
+61 8 9360 2058
Fax 90110 0
Email 90110 0
[email protected]
Contact person for public queries
Name 90111 0
Irene Serfaty
Address 90111 0
School of Psychology & Exercise Science,
Murdoch University,
90 South Street, Murdoch WA 6150
Country 90111 0
Australia
Phone 90111 0
+61 452223805
Fax 90111 0
Email 90111 0
[email protected]
Contact person for scientific queries
Name 90112 0
Irene Serfaty
Address 90112 0
School of Psychology & Exercise Science,
Murdoch University,
90 South Street, Murdoch WA 6150
Country 90112 0
Australia
Phone 90112 0
+61 452223805
Fax 90112 0
Email 90112 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
Due to confidentiality reasons.


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.