Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000391875
Ethics application status
Approved
Date submitted
3/04/2012
Date registered
5/04/2012
Date last updated
12/04/2012
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 early adolescence
Scientific title
Examining the efficacy of the Tuning in to Teens parenting program in improving parents' emotion socialisation practices and reducing or preventing internalising and externalising problems in early adolescence
Secondary ID [1] 280272 0
Nil
Universal Trial Number (UTN)
U1111-1129-7207
Trial acronym
TinT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parents' emotional competence 286220 0
Parents' emotion socialisation practices 286223 0
Family functioning 286224 0
Child internalising (internalisiation of problems in early adolescence; e.g., anxiety, depression, somatic complaints) 286225 0
Child externalising (externalisation of problems in early adolescence; e.g., conduct problems, hyperactivity) 286226 0
Condition category
Condition code
Public Health 286436 286436 0 0
Health promotion/education
Mental Health 286450 286450 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 of six sessions). Using a structured manual, the program was delivered by two of the program authors (Ann Harley and Christiane Kehoe). Co-leaders were volunteers who were mental health professionals or psychology graduates and were trained in the Tuning in to Kids program (Havighurst & Harley, 2007). Parents of Grade six children learned skills in emotional competence and were taught how to respond to their children's negative emotions. Parents also learned how to respond with empathy and how to manage rejection and facilitate their child's emotional autonomy. The method used included psycho education, mindfulness techniques, emotion awareness and regulation strategies, and role plays. Parents and their Grade six children completed questionnaires pre and post intervention, and the following year when the child was in their first year of secondary school (Term 2, Grade 7).
Intervention code [1] 284623 0
Prevention
Intervention code [2] 284625 0
Behaviour
Comparator / control treatment
The control group took part in a questionnaire study on the transition to high school. Parents and their Grade six child completed identical questionnaires to the intervention group. Questionnaires were collected when the child was in Grade six and again, the following year when the child was in their first year of secondary school (Term 2, Grade 7). The control group did not receive an intervention.
Control group
Active

Outcomes
Primary outcome [1] 286883 0
Parental mental health
Assessed via self-report questionnaires using the General Health Questionnaire (GHQ 28; Goldberg, 1981; Goldberg & Williams, 1991).
Timepoint [1] 286883 0
pre intervention (when child was in Grade six), post intervention and when child was in Term 2 in Grade 7.
Primary outcome [2] 286884 0
Parent emotional competence
The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) was used to assess parents' self-reported difficulties with emotion awareness and regulation.
Timepoint [2] 286884 0
pre intervention (when child was in Grade six), post intervention and when child was in Term 2 in Grade 7.
Primary outcome [3] 286885 0
Parent emotion socialisation practices
The Emotions as a Child Scale (EAC- parent self-report version; EAC- child-report version; Magai, 1996) was used to measure parent emotion socialisation practices.
Timepoint [3] 286885 0
pre intervention (when child was in Grade six), post intervention and when child was in Term 2 in Grade 7.
Secondary outcome [1] 296905 0
Child internalising difficulties
Child internalising difficulties were measured with the Spence Child Anxiety Scale (child self-report; Spence, 1998), the Spence Child Anxiety Scale for Parents (parent-report; Nauta et al., 2004), the Child Depression Inventory short-form (child self-report; Kovacs, 1981) and the Child Depression Inventory (parent report; Garber, 1984).
Timepoint [1] 296905 0
pre intervention (when child was in Grade six), post intervention and when child was in Term 2 in Grade 7.
Secondary outcome [2] 296906 0
Child externalising difficulties
Child externalising difficulties was measured with the Strength and Difficulties Questionnaire (parent and child report; Goodman, 1997).
Timepoint [2] 296906 0
pre intervention (when child was in Grade six), post intervention and when child was in Term 2 in Grade 7.
Secondary outcome [3] 296907 0
Family functioning
Family functioning was measured with the Family Conflict Scale (parent and child report; Arthur, Hawkins, Catalano, & Pollard, 1998) and the General Functioning subscale from the McMaster Family Assessment Device (parent and child report; Epstein, Baldwin, & Bishop, 1983)
Timepoint [3] 296907 0
pre intervention (when child was in Grade six), post intervention and when child was in Term 2 in Grade 7.

Eligibility
Key inclusion criteria
Primary carer (males or females; age range was not restricted, parents ranged in age from 32 - 65.8 years; Mean age = 44.1) with Grade six child (male or female; age range was restricted to 11-13 years; Mean age of child participants was = 12.01)
Minimum age
32 Years
Maximum age
65 Years
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. Children 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)
Group randomised study (schools randomised into intervention or waitlist condition). 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285039 0
University
Name [1] 285039 0
The University of Melbourne
Country [1] 285039 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Mindful, Centre for Training and Research in Developmental Health, The University of Melbourne
50 Flemington St
Flemington, 3130
Victoria
Country
Australia
Secondary sponsor category [1] 283907 0
Other Collaborative groups
Name [1] 283907 0
MacKillop Family Services
Address [1] 283907 0
MacKillop Family Services
123 Paisley St
Footscray, 3011
Victoria
Country [1] 283907 0
Australia
Other collaborator category [1] 260700 0
Other Collaborative groups
Name [1] 260700 0
Dianella Community Health/School Focused Youth Service
Address [1] 260700 0
Dianella Community Health
35 Johnstone Street
Broadmeadows, 3047
Victoria
Country [1] 260700 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287042 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 287042 0
Ethics committee country [1] 287042 0
Australia
Date submitted for ethics approval [1] 287042 0
Approval date [1] 287042 0
26/03/2008
Ethics approval number [1] 287042 0
0723626
Ethics committee name [2] 287045 0
Department of Education and Early Childhood Development
Ethics committee address [2] 287045 0
Ethics committee country [2] 287045 0
Australia
Date submitted for ethics approval [2] 287045 0
Approval date [2] 287045 0
04/04/2008
Ethics approval number [2] 287045 0
SOS003805

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

Contacts
Principal investigator
Name 34019 0
Address 34019 0
Country 34019 0
Phone 34019 0
Fax 34019 0
Email 34019 0
Contact person for public queries
Name 17266 0
Christiane Kehoe
Address 17266 0
Mindful, Centre for Training and Research in Developmental Health, The University of Melbourne
50 Flemington St
Flemington, 3130
Victoria
Country 17266 0
Australia
Phone 17266 0
61 3 9371 0207
Fax 17266 0
61 3 9371 0250
Email 17266 0
[email protected]
Contact person for scientific queries
Name 8194 0
Christiane Kehoe
Address 8194 0
Mindful, Centre for Training and Research in Developmental Health, The University of Melbourne
50 Flemington St
Flemington, 3130
Victoria
Country 8194 0
Australia
Phone 8194 0
61 3 9371 0207
Fax 8194 0
61 3 9371 0250
Email 8194 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
No additional documents have been identified.