Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000814572
Ethics application status
Approved
Date submitted
20/07/2015
Date registered
6/08/2015
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a family music psychotherapy program on conflict and interaction in parents with a history of childhood interpersonal trauma and their adolescent children.
Scientific title
Efficacy of a family music psychotherapy program versus wait list control on conflict and interaction in parents with a history of childhood interpersonal trauma and their adolescent children.
Secondary ID [1] 287117 0
nil
Universal Trial Number (UTN)
U1111-1172-3631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
parent-child relationship difficulties
 295645 0
parental history of interpersonal childhood trauma 295646 0
Condition category
Condition code
Mental Health 295926 295926 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tuning Relationships with Music is an intervention for parents with a history of childhood interpersonal trauma and their adolescent children, who are experiencing conflict in their relationship. Following clinical assessment, eight 1 hour sessions will be provided by a family therapist who has additional training in music therapy. Parents and adolescents will each attend 2 individual sessions and 4 joint sessions over a 4 month period. Both individual and conjoint sessions will comprise (1) psychoeducation about the effects of trauma on emotions and relationships, emotion coaching (parent only), adolescent social and emotional development, emotional intelligence, and principles of emotionally safe communication; (2) rhythms generated by parents and adolescents with the therapist on untuned drums will be used to help parents and adolescents focus on the non-verbal elements of their communication, and to learn how to identify, interrupt and repair negative cycles of interaction; (3) precomposed 'call and response' musical patterns on tuned pentatonic drums will be used to assist parents and adolescents to learn the nonverbal elements of emotionally safe communication - in particular reflective listening and contingent or empathic response. These music patterns will then be used to support teaching verbal 'safe talking' scripts and parent-adolescent generated verbal discussion of their issues. Treatment adherence will be monitored by using a fidelity checklist. An attendence register will also be kept.
Intervention code [1] 292363 0
Lifestyle
Intervention code [2] 292417 0
Behaviour
Comparator / control treatment
Parents and adolescents in the wait list condition will receive standard treatment through the family support service. This includes parenting education and support groups, practical support, supportive counselling and case management. The intervention will be offered to the wait list group immediately after the intervention group has completed all sessions over a 4 month period, and after both groups have completed post-measures.
Control group
Active

Outcomes
Primary outcome [1] 295604 0
Interpersonal conflict measured by the Conflict Behaviour Questionnaire and the Parent-Adolescent Relationship Questionnaire (completed by both parent and adolescent).
Timepoint [1] 295604 0
4 months after commencement of intervention.
Primary outcome [2] 295605 0
Parental emotion coaching measured by the Emotions as a Child Self-Rating Measure (completed by both parent and adolescent)
Timepoint [2] 295605 0
4 months after commencement of intervention
Primary outcome [3] 295607 0
Parental competence, measured by the Assessment of Parenting Competencies Revised (observational measure completed by both parent and adolescent) and the Parenting Sense of Competence Scale (parent self-report measure, completed by parent only)
Timepoint [3] 295607 0
4 months after commencement of intervention
Secondary outcome [1] 315964 0
Mental health, measured by the Strengths and Difficulties Questionnaire (adolescent) and the Depression, Anxiety and Stress Scale (parent).
Timepoint [1] 315964 0
4 months after comencement of intervention
Secondary outcome [2] 316136 0
Relationship quality, measured by the Parent Adolescent Relationship Questionnaire (completed by parent and adolescent).
Timepoint [2] 316136 0
4 months after commencement of intervention.

Eligibility
Key inclusion criteria
Parents who have a history of interpersonal childhood trauma as measured by the Childhood Trauma Questionnaire and the Betrayal Trauma Survey, and their adolescent children between 10 and 18 years, where they are experiencing conflict in their relationship as measured by the Conflict Behaviour Questionnaire.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
current perpetration of abuse, homelessness, diagnosed severe auditory problems, intellectual disability, acquired brain injury, autism spectrum disorder, psychosis.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation will be carried out by an independent researcher, using numbers allocated to each case.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using coin toss.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
One group receives the intervention; the other group receives treatment as usual. The second group will receive the intervention after post-measures have been administered.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cluster analyses will be used with Time 1 data.
Paired samples T tests, or Wilcoxin Signed Rank Test if normal distribution cannot be inferred will be used to see whether there are changes between Time 1 and Time 2 data.
Data obtained from the observational measure will additionally be coded then examined using a State Space Grid analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
5/01/2016
Date of last participant enrolment
Anticipated
1/06/2017
Actual
29/05/2017
Date of last data collection
Anticipated
30/08/2017
Actual
30/09/2017
Sample size
Target
80
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9990 0
3072 - Preston
Recruitment postcode(s) [2] 9991 0
3047 - Broadmeadows

Funding & Sponsors
Funding source category [1] 291675 0
University
Name [1] 291675 0
University of Melbourne
Country [1] 291675 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Mindful Centre for Training and Research in Developmental Health
Department of Psychiatry
University of Melbourne
Building C
50 Flemington Street
Flemington 3031
Melbourne
Victoria
Country
Australia
Secondary sponsor category [1] 290353 0
None
Name [1] 290353 0
Address [1] 290353 0
Country [1] 290353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293205 0
The University of Melbourne Human Ethics Committee
Ethics committee address [1] 293205 0
Ethics committee country [1] 293205 0
Australia
Date submitted for ethics approval [1] 293205 0
18/08/2015
Approval date [1] 293205 0
30/09/2015
Ethics approval number [1] 293205 0
1545067.1
Ethics committee name [2] 293206 0
Anglicare Victoria Research Ethics Committee
Ethics committee address [2] 293206 0
Ethics committee country [2] 293206 0
Australia
Date submitted for ethics approval [2] 293206 0
17/09/2015
Approval date [2] 293206 0
Ethics approval number [2] 293206 0
not yet allocated

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

Contacts
Principal investigator
Name 58890 0
Dr Sophie Havighurst
Address 58890 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
University of Melbourne
Building C
50 Flemington Street
Flemington 3031
Melbourne
Victoria
Country 58890 0
Australia
Phone 58890 0
+61 3 9371 0202
Fax 58890 0
Email 58890 0
[email protected]
Contact person for public queries
Name 58891 0
Vivienne Colegrove
Address 58891 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
University of Melbourne
Building C
50 Flemington Street
Flemington 3031
Melbourne
Victoria
Country 58891 0
Australia
Phone 58891 0
+61 409949300
Fax 58891 0
Email 58891 0
[email protected]
Contact person for scientific queries
Name 58892 0
Vivienne Colegrove
Address 58892 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry
University of Melbourne
Building C
50 Flemington Street
Flemington 3031
Melbourne
Victoria
Country 58892 0
Australia
Phone 58892 0
+61 409949300
Fax 58892 0
Email 58892 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePilot randomized controlled trial of Tuning Relationships with Music: Intervention for parents with a trauma history and their adolescent.2018https://dx.doi.org/10.1016/j.chiabu.2018.02.017
N.B. These documents automatically identified may not have been verified by the study sponsor.