Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000579695
Ethics application status
Approved
Date submitted
23/05/2014
Date registered
29/05/2014
Date last updated
29/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tuning in to Teens: A parenting intervention for promoting parents' emotion socialisation practices and preventing internalising and externalising difficulties in adolescence
Scientific title
Tuning in to Teens: The prevention of mental health difficulties in adolescents using and emotion-focussed parenting program
Secondary ID [1] 284654 0
nil known
Universal Trial Number (UTN)
U1111-1157-2489
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adolescent depression 291971 0
adolescent behaviour problems 291972 0
Adolescent anxiety 291973 0
Adolescent Somatic Complaints 291974 0
Adolescent emotional competence 291975 0
Parent psychological wellbeing 291976 0
Parent emotional competence 291977 0
Parent psychological flexibility 291978 0
Parent emotion socialisation 291979 0
Family functioning 291980 0
Condition category
Condition code
Mental Health 292320 292320 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TinT is a group parenting program held weekly for two hours per week over a period of 6 weeks (total six sessions). Using a structured manual, the program is being delivered by the program authors (Sophie Havighurst, Ann Harley, Christiane Kehoe) and an accredited Tuning in to Teens facilitator Dr Katherine Wilson. Co-leaders are volunteers who are mental health professional and are trained in the Tuning in to Teens program (Havighurst, Harley, Kehoe & Pizarro, 2012).

The program aims to teach parents skills in responding to their adolescents' emotions, and the techniques used are psycho-education, mindfulness activities, role plays, discussion, dvd's. We aim to target parent functioning (i.e., parent psychological wellbeing, parent emotional competence, parent emotion socialisation) to improve family functioning and youth emotional- and behavioural functioning.
Intervention code [1] 289437 0
Prevention
Intervention code [2] 289438 0
Behaviour
Comparator / control treatment
The control group is a waitlist-control group who will receive the program one year post baseline assessment.
Control group
Active

Outcomes
Primary outcome [1] 292184 0
Parental psychological wellbeing
Assessed via self-report questionnaires using the General Health Questionnaire (GHQ 28; Goldberg, 1981; Goldberg & Williams, 1991).
Timepoint [1] 292184 0
pre-intervention (when child was in Grade 7), post intervention and 12 months follow-up
Primary outcome [2] 292185 0
Parent emotional competence
The Diffficulties in Emotion Regulation Scale (Gratz & Roemer, 2004) was used to assess parents' self-reported difficulties with emotion awareness and regulation.
Timepoint [2] 292185 0
pre-intervention (when child was in year 7), post intervention and 12 months follow-up.
Primary outcome [3] 292187 0
Parent emotion socialisation practices
The Emotions as a Child Scale (Magai, 1996; Magai et al, 2006)
Timepoint [3] 292187 0
pre-intervention (when child was in year 7), post intervention and 12 months follow-up.
Secondary outcome [1] 308391 0
Youth externalising difficulties
Assessed with the Strength and Difficulties Questionnaire (parent and child report; Goodman, 1997)
Timepoint [1] 308391 0
pre-intervention and 12 months follow-up
Secondary outcome [2] 308392 0
Youth internalising difficulties
Assessed with the Spence Child Anxiety Scale (parent and youth report; Spence, 1998; Nautal et al., 2004); the Child Depression Inventory short-form (youth self-report; KOvacs, 1981) and Child Depression Inventory (parent-report; Garber, 1984).
Timepoint [2] 308392 0
pre-intervention, and 12 months follow-up
Secondary outcome [3] 308393 0
Family functioning
Assessed with the Family Conflict Scale (parent and youth-report; Arhur, Hawkins, Catalano, & Pollard, 1998) and the General Functioning subscale from the McMaster Family Assessment Device (parent and youth-report; Epstein, Baldwin, & Bishop, 1983)
Timepoint [3] 308393 0
pre-intervention and 12 months follow-up
Secondary outcome [4] 308394 0
Youth mental illness
Diagnostic Interview for Children and Adolescents (Reich, Welner, Herjanic, & Multihealth-System Staff, 1997).
Timepoint [4] 308394 0
At 12 months follow-up only.

Eligibility
Key inclusion criteria
Primary carer (males or females' age range is not restricted) with adolescent child (male or female; adolescents had to be currently enrolled in year 7 in participating schools; approximate age range 12-14 years).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents without sufficient English language skills to answer questionnaires or understand the program content were excluded. Youth with a primary diagnosis of a communication or pervasive developmental disorder were excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools are randomised into intervention and waitlist-control conditions after return of baseline questionnaires. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation clusters
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2014
Actual
28/03/2014
Date of last participant enrolment
Anticipated
26/10/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
290
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8138 0
3031 - Flemington

Funding & Sponsors
Funding source category [1] 289281 0
University
Name [1] 289281 0
The University of Melbourne
Country [1] 289281 0
Australia
Funding source category [2] 289282 0
Charities/Societies/Foundations
Name [2] 289282 0
Australian Rotary Health
Country [2] 289282 0
Australia
Primary sponsor type
University
Name
Mindful, Centre for Training and Research in Developmental Health, Department Psychiatry, The University of Melbourne
Address
The University of Melbourne,
Department Psychiatry
50 Flemington St
Travancore, 3031
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 287956 0
Charities/Societies/Foundations
Name [1] 287956 0
Australian Rotary Health
Address [1] 287956 0
PO BOX 3455
Parramatta
NSW 2124
Country [1] 287956 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291049 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 291049 0
Ethics committee country [1] 291049 0
Australia
Date submitted for ethics approval [1] 291049 0
Approval date [1] 291049 0
21/01/2014
Ethics approval number [1] 291049 0
1341214
Ethics committee name [2] 291050 0
Department of Education and Early Childhood Development
Ethics committee address [2] 291050 0
Ethics committee country [2] 291050 0
Australia
Date submitted for ethics approval [2] 291050 0
Approval date [2] 291050 0
07/03/2014
Ethics approval number [2] 291050 0
2014_002261

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

Contacts
Principal investigator
Name 48654 0
Dr Sophie Havighurst
Address 48654 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry,The University of Melbourne
Building C, 50 Flemington Street, Travancore, 3031
Victoria
Country 48654 0
Australia
Phone 48654 0
+61 3 9371 0200
Fax 48654 0
+61 3 93710250
Email 48654 0
[email protected]
Contact person for public queries
Name 48655 0
Christiane Kehoe
Address 48655 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry,The University of Melbourne
Building C, 50 Flemington Street, Travancore, 3031
Victoria
Country 48655 0
Australia
Phone 48655 0
+61 3 9371 0207
Fax 48655 0
+61 3 9371 0250
Email 48655 0
[email protected]
Contact person for scientific queries
Name 48656 0
Sophie Havighurst
Address 48656 0
Mindful: Centre for Training and Research in Developmental Health
Department of Psychiatry,The University of Melbourne
Building C, 50 Flemington Street, Travancore, 3031
Victoria
Country 48656 0
Australia
Phone 48656 0
+61 3 9371 0200
Fax 48656 0
+61 3 9371 0250
Email 48656 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
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