Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000721707
Ethics application status
Approved
Date submitted
11/05/2022
Date registered
19/05/2022
Date last updated
16/09/2022
Date data sharing statement initially provided
19/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Tuning Relationships with Music therapy for traumatised parents and adolescents experiencing conflict in their relationship : An Implementation Study.
Scientific title
Tuning Relationships with Music psychotherapy for traumatised parents and adolescents experiencing relational conflict: Exploring changes in dyads' conflict interaction and counsellors' implementation experiences..
Secondary ID [1] 307071 0
none
Universal Trial Number (UTN)
U1111-1278-1031
Trial acronym
Linked study record
The current study is a follow-up study related to registration record ACTRN1261500081457

Health condition
Health condition(s) or problem(s) studied:
parent-adolescent conflict 326246 0
Condition category
Condition code
Mental Health 323547 323547 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two aspects of this research trial.
1. Tuning Relationships with Music (TRM) is a dyadic psychotherapy for parents and adolescents (10 - 18 years) affected by previous experiences of sexual or physical assault, who are experiencing high levels of conflict in their relationship. Dyads will complete 8 x 1 hour weekly sessions of therapy conducted face-to-face or online. Therapy involves talking and playing musical instruments to assist dyads to manage emotional reactivity, and learn new nonverbal as well as verbal patterns of interaction that characterise safe and respectful interaction about issues that may cause conflict. Materials: Dyads will be asked to complete online questionnaires pre and post intervention, and will be provided with psycho-educational materials. Psycho-educational materials were developed specifically for Tuning Relationships with Music, including adapted versions of handouts from the Tuning in to Teens (TINT) parenting course (Havighurst, Harley & Kehoe, 2019) and handouts developed by Dr Colegrove (Colegrove, 2019). These are available to professionals who attend training in TRM or TINT, and to families attending these programs.
2. Counsellors working at the Gippsland Centre Against Sexual Assault (GCASA) will be trained to deliver TRM by Dr Colegrove, a qualified family therapist with 22 years experience. Training is 24 hours in duration and will be offered over four days either at GCASA or via zoom. The training will include powerpoint presentations and experiential learning about how to deliver the therapy. Counsellors will then offer TRM to families either face-to-face or via telehealth. Face-to-face sessions will be offered at GCASA. For online sessions, dyads will attend from their home. All counsellors are fully qualified and experienced with working with children and parents who have experienced sexual and/or other forms of violence. Materials: Counsellors will be provided with an intervention manual which includes handouts to be given to families (see above). The intervention manual was written by Dr Colegrove prior to this study (Colegrove, 2019) and is available to professionals completing TRM training. Counsellors will be asked to complete questionnaires and a semi-structured interview about their experience of implementing TRM in their service. They will complete fidelity checklists to ensure adherence. They will attend supervision with Dr Colegrove for 1 hour fortnightly for the duration of the trial. Supervision will be offered to counsellors as a group, and will focus on discussing issues connected to the implementation of TRM with families.
Adverse events: It is possible that completing assessment measures may cause distress for some parents and adolescents. Participants will be offered the opportunity to complete screening and baseline measures with the support of Dr Colegrove or their counsellor if they wish. They will also be given options for follow-up support with Dr Colegrove, their counsellor or referring worker, or given information about external options for support if they prefer this (e.g. Parentline, Kids’ Helpline).
Intervention code [1] 323537 0
Treatment: Other
Comparator / control treatment
The control group will receive treatment as usual (TAU). This will comprise family therapy, parent support, and individual trauma therapy (adults and children). The intervention group will also receive TAU.
Control group
Active

Outcomes
Primary outcome [1] 331300 0
change in parent-adolescent conflict as measured by the Conflict Behaviour Questionnaire (Print et al., 1979), completed by both parent and adolescent
Timepoint [1] 331300 0
Baseline and 4 months after intervention commencement
Primary outcome [2] 331301 0
changes in parent reactivity and responsiveness as measured by the the Assessment 0f Responsivity and Reactivity Scale (Colegrove and Havighurst, 2016).
Timepoint [2] 331301 0
Baseline and 4 months after intervention commencement
Primary outcome [3] 331302 0
Counsellors' experiences of implementing Tuning Relationships with Music
Timepoint [3] 331302 0
completion of questionnaire and semi-structured interview 1 month after counsellors have completed implementing TRM. The questionnaire and semi-structured interview were designed specifically for this study.
Secondary outcome [1] 409473 0
change in adolescent mental health, as measured by the Strength and Difficulties Questionnaire (Goodman, 1997), completed by both parent and adolescent
Timepoint [1] 409473 0
Baseline and 4 months after intervention commencement
Secondary outcome [2] 409474 0
change in parent mental health as measured by the Depression Anxiety and Stress Scale - short form (Henry and Crawford, 2005)
Timepoint [2] 409474 0
Baseline and 4 months after intervention commencement
Secondary outcome [3] 409475 0
changes in parent and adolescent emotion regulation - short form (Kaufman et al., 2015), to be completed by parent and adolescent
Timepoint [3] 409475 0
Baseline and 4 months after intervention commencement
Secondary outcome [4] 409476 0
changes in parent responsiveness to their adolescent's emotions, measured by the Emotions as a Child Self-Rating Measure (Magai, 1996), completed by parent and adolescent
Timepoint [4] 409476 0
Baseline and 4 months after intervention commencement

Eligibility
Key inclusion criteria
1. Parents and adolescents (10 - 18 years) who have experienced sexual and/or physical violence, who are receiving counselling from the Gippsland Centre Against Sexual Assault.
2. Counsellors employed by the Gippsland Centre Against Sexual Assault.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Parents and adolescents: Current exposure to or perpetration of sexual and/or physical violence including in the context of child custody disputes involving the adolescent participating in the study, homelessness, untreated psychosis, severe intellectual disability or acquired brain injury, profound hearing loss, inability to speak or understand English.
2. Counsellors: No exclusion criteria provided they are employed in a counselling role at GCASA..

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 be conducted using the computer software 'research randomiser' by Professor Havighurst, who is not located at the intervention site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using 'research randomiser'
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
Sample size: 130 dyads will be recruited to this study, as calculated by 'G-Power' as the number required to detect small effect sizes.
Analysis: quantitative data will be analysed using paired sample T Tests, analyses of covariance, and cluster analyses with time one data. Qualitative data will be analysed via frequency analyses (counsellor questionnaire) and reflexive thematic analysis (semi-structured interviews).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2022
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
130
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22353 0
Gippsland Centre Against Sexual Assault - Morwell
Recruitment postcode(s) [1] 37495 0
3840 - Morwell

Funding & Sponsors
Funding source category [1] 311445 0
University
Name [1] 311445 0
University of Melbourne
Country [1] 311445 0
Australia
Funding source category [2] 311446 0
Other Collaborative groups
Name [2] 311446 0
Gippsland Centre Against Sexual Assault
Country [2] 311446 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Professor Havighurst
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
The University of Melbourne
Building C
50 Flemington Street
Travancore
Victoria 3032
Country
Australia
Secondary sponsor category [1] 312842 0
Other Collaborative groups
Name [1] 312842 0
Gippsland Centre Against Sexual Assault
Address [1] 312842 0
Ms Jane Barr
Gippsland Centre Against Sexual Assault
Multidisciplinary Centre
31-41 Buckley Street
Morwell
Victoria 3840
Country [1] 312842 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310866 0
University of Melbourne Human Research Ethics Committee STEMM2
Ethics committee address [1] 310866 0
Ethics committee country [1] 310866 0
Australia
Date submitted for ethics approval [1] 310866 0
30/06/2022
Approval date [1] 310866 0
15/09/2022
Ethics approval number [1] 310866 0

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

Contacts
Principal investigator
Name 119150 0
Prof Professor Sophie Havighurst
Address 119150 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
The University of Melbourne
Building C
50 Flemington Street
Travancore, Victoria 3032
Country 119150 0
Australia
Phone 119150 0
+61 383444458
Fax 119150 0
Email 119150 0
[email protected]
Contact person for public queries
Name 119151 0
Vivienne Colegrove
Address 119151 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
The University of Melbourne
Building C
50 Flemington Street
Travancore, Victoria 3032
Country 119151 0
Australia
Phone 119151 0
+61 409949300
Fax 119151 0
Email 119151 0
[email protected]
Contact person for scientific queries
Name 119152 0
Vivienne Colegrove
Address 119152 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
The University of Melbourne
Building C
50 Flemington Street
Travancore, Victoria 3032
Country 119152 0
Australia
Phone 119152 0
+61 409949300
Fax 119152 0
Email 119152 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
This will not be provided in order to protect client confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15975Study protocol  [email protected]



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.