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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]

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

parental history of interpersonal childhood trauma

Condition category

Condition code

Mental Health

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]

Lifestyle

Intervention code [2]

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]

Interpersonal conflict measured by the Conflict Behaviour Questionnaire and the Parent-Adolescent Relationship Questionnaire (completed by both parent and adolescent).

Timepoint [1]

4 months after commencement of intervention.

Primary outcome [2]

Parental emotion coaching measured by the Emotions as a Child Self-Rating Measure (completed by both parent and adolescent)

Timepoint [2]

4 months after commencement of intervention

Primary outcome [3]

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]

4 months after commencement of intervention

Secondary outcome [1]

Mental health, measured by the Strengths and Difficulties Questionnaire (adolescent) and the Depression, Anxiety and Stress Scale (parent).

Timepoint [1]

4 months after comencement of intervention

Secondary outcome [2]

Relationship quality, measured by the Parent Adolescent Relationship Questionnaire (completed by parent and adolescent).

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3072 - Preston

Recruitment postcode(s) [2]

3047 - Broadmeadows

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Melbourne

Address [1]

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 [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Melbourne Human Ethics Committee

Ethics committee address [1]

Office for Research Ethics & Integrity
 Level 1, 780 Elizabeth St
 The University of Melbourne
 VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/08/2015

Approval date [1]

30/09/2015

Ethics approval number [1]

1545067.1

Ethics committee name [2]

Anglicare Victoria Research Ethics Committee

Ethics committee address [2]

PO Box 45
Abbotsford
Victoria 3067

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

17/09/2015

Approval date [2]

Ethics approval number [2]

not yet allocated

Summary

Brief summary

The proposed PhD study will involve the development and pilot testing of Tuning Relationships with Music (TRM), a new systemic intervention that aims to help parents with a history of childhood interpersonal trauma and their adolescent children (10-18 years) improve the quality of their relationship. Parents with a trauma history often struggle to connect to their children. Adolescent behaviour can trigger unresolved trauma memories for a parent, resulting in an escalation of conflictual parent-child interactions which may compromise a young person’s development, leading to problems with emotional and social functioning, and mental health difficulties. Therefore it is important to intervene early with families with these risk factors in order to prevent the emergence of problems and strengthen the parent-child relationship, which has been found to play an important protective role in supporting optimal developmental outcomes for young people. TRM aims to use music as a vehicle to work directly with nonverbal maladaptive patterns of communication, to teach parents and teens how to recognise, interrupt and repair negative cycles of interaction, to learn responsive ways of relating, and to help parents use emotion coaching strategies to identify and empathically respond to their teen’s nonverbal and verbal expressions of emotion.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Sophie Havighurst

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

Phone

+61 3 9371 0202

Fax

sophie.h@unimelb.edu.au

Contact person for public queries

Name

Vivienne Colegrove

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

Phone

+61 409949300

Fax

vcolegrove@student.unimelb.edu.au

Contact person for scientific queries

Name

Vivienne Colegrove

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

Phone

+61 409949300

Fax

vcolegrove@student.unimelb.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Pilot randomized controlled trial of Tuning Relationships with Music: Intervention for parents with a trauma history and their adolescent.	2018	https://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.

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Documents added manually

Documents added automatically