Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001460392
Ethics application status
Approved
Date submitted
12/10/2017
Date registered
16/10/2017
Date last updated
14/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-method assessment of parent-adolescent relationships and the effectiveness of a Teen Triple P discussion group in promoting adolescent functioning among adolescents with anxiety and conduct disorders.
Scientific title
A pre-post multi-method assessment of parent-adolescent relationships and the effectiveness of the Teen Triple P parent discussion group '"Coping with Teenagers' Emotions" on promoting supportive parenting and improving adolescent functioning among anxiety- and conduct-disordered youths aged 11 to 17.
Secondary ID [1] 292829 0
None
Universal Trial Number (UTN)
U1111-1203-6777
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 304668 0
Conduct Disorder 304669 0
Condition category
Condition code
Mental Health 303984 303984 0 0
Anxiety
Mental Health 303985 303985 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a single time-point, 2-hour discussion group that will be offered to parents as a stand-alone program. The ‘Coping with Teenagers’ Emotions’ discussion group is a 2-hour group (part of the Teen Triple P-Positive Parenting Program) that aims to teach parents strategies to encourage their adolescent to better manage their emotions, to deal with emotional behaviour and to effectively resolve problems that have triggered the emotional behaviour. The group sessions will be facilitated by a by a trained and accredited Triple P practitioner with approximately 10 to 20 parents in attendance per group. During the discussion group, parents will watch DVD segments to prompt group discussion and provide step-by-step suggestions about positive parenting strategies to help prevent problems and to cope with adolescents’ emotions and support the adolescent to deal appropriately with their feelings. The group will include active discussions of the parenting strategies introduced and will involve parents in developing a personalised parenting plan. Parents will be guided through the exercises in the workbook by the facilitator. The tasks have been designed to further parents’ understanding of the strategies introduced and issues raised by the group and to support implementation of the suggested strategies with their family. Every parent will receive a ‘Coping with Teenagers’ Emotions’ workbook that includes information and practical exercises covered during the discussion group. The workbook reinforces the material presented during the group and can be used at home with partners who were unable to attend.

Parent-adolescent dyads will take part in two face-to-face multi-method assessment sessions, approximately six to eight weeks apart, pre- and post-intervention. The Time 1 (T1) pre-intervention assessment will commence with a diagnostic interview (A) administered to parents and adolescents to classify families into adolescent mental health categories i.e., Anxiety Disorder, Conduct Disorder, No Disorder. Parents and adolescents will complete questionnaires (B) independently to provide information on demographics, parenting behaviours and practices, parents’ and adolescents’ psychological wellbeing, and the quality of the parent-adolescent relationship. The battery of measures will be prepared in separate parent and adolescent survey packages. Parent-adolescent interactions will then be observed during adolescent completion of a problem-solving puzzle task to assess for the presence of behaviours characteristic of connectedness and hostility in the relationship (C). The video recording of the interactions will be played back to parents and adolescents individually to assess their beliefs, reactions and attributions during the problem-solving task (D). The Time 2 (T2) post-intervention assessment will involve tasks B, C and D. Longitudinal data will be obtained from parent-adolescent dyads at Time 3 (T3), 6 months after T2, via quantitative measures only (B).
Intervention code [1] 299080 0
Behaviour
Comparator / control treatment
No control group.
As all three study groups will be given the same intervention and subjects are not randomised, none of the groups will be considered a control group in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303320 0
Parent-adolescent relationship as assessed by the Observation Task completed by parents and adolescents.
Timepoint [1] 303320 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
Primary outcome [2] 303321 0
Parent-adolescent relationship as assessed by the Video-Mediated Recall/Feedback Task completed by parents and adolescents.
Timepoint [2] 303321 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
Primary outcome [3] 303322 0
Parent-adolescent relationship as assessed by the self-report Parent-Adolescent Relationship Scale (PARS) completed by parents and adolescents.
Timepoint [3] 303322 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
T3: 6-Month Follow-Up (6 months after completion of T2)
Secondary outcome [1] 338626 0
Adolescent functioning as assessed by the Adolescent Functioning Scale (AFS) completed by parents and adolescents.
Timepoint [1] 338626 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
T3: 6-Month Follow-Up (6 months after completion of T2)
Secondary outcome [2] 339739 0
Parenting practices as assessed by the Alabama Parenting Questionnaire-9 (APQ-9) completed by parents and adolescents.
Timepoint [2] 339739 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
T3: 6-Month Follow-Up (6 months after completion of T2)
Secondary outcome [3] 339740 0
Parent functioning as assessed by the Parental Psychological Flexibility Questionnaire (PPF) completed by parents.
Timepoint [3] 339740 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
T3: 6-Month Follow-Up (6 months after completion of T2)
Secondary outcome [4] 339741 0
Parent functioning as assessed by the Depression Anxiety and Stress Scale, 21 items (DASS-21) completed by parents.
Timepoint [4] 339741 0
T1: Pre-Intervention Assessment
T2: Post-Intervention Assessment (6 to 8 weeks after T1)
T3: 6-Month Follow-Up (6 months after completion of T2)

Eligibility
Key inclusion criteria
Participants will be adolescents aged between 11 and 17 years and their parents. A minimum of 114 parent-adolescent dyads in total will be recruited for this study, with the goal of recruiting at least 38 dyads for each of the three study groups: 1) Anxiety Disorder Group, 2) Conduct Disorder Group, or a 3) No Disorder Group. All recruited participants will complete an initial diagnostic interview using the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent versions (ADIS-C/P). Based on the results from the ADIS-C/P interviews, participants who meet criteria for an anxiety disorder will be categorised in the Anxiety Disorder Group and those who meet criteria for a Conduct Disorder will be categorised in the Conduct Disorder Group. The Anxiety Disorder Group sample will consist of parent-adolescent dyads with adolescents who meet DSM-IV criteria for anxiety disorders, and are consistent with DSM-5 classification for anxiety disorders, which include: Separation Anxiety Disorder, Selective Mutism, Specific Phobia, Social Anxiety Disorder (Social Phobia), Panic Disorder, Agoraphobia, and Generalised Anxiety Disorder. The Conduct Disorder Group will consist of parent-adolescent dyads with adolescents who meet DSM-IV criteria for externalising disorders, and are consistent with DSM-5 classification for Disruptive, Impulse-Control, and Conduct Disorders, which include: Conduct Disorder and Oppositional Defiant Disorder. Participants who have completed the ADIS-C/P and do not meet criteria for these two categories, and who do not fulfill the key exclusion criteria, will be remain eligible for the study and categorised in the No Disorder Group. Participants in the No Disorder Group are included if they have not accessed a child and/or adolescent mental health service for treatment in the 12 months prior to recruitment to this study.

The ratio of male to female adolescent participants will be balanced (1:1) as far as possible, within ethical limits and feasibility. For parents, efforts will be made to recruit both mothers and fathers; however, as is typical in parenting research, it is expected that a higher ratio of mothers will participate in the study.
Minimum age
11 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria which apply are:
• Participants from non-English speaking backgrounds or whose English is insufficient to participate. This will be determined by the telephone screening process and includes both adolescents and their parents.
• Adolescents who are not in the primary care of their parents. This also applies to adolescents in foster care who are in temporary placements.
• Adolescents and/or their parents who meet diagnostic criteria for one or more of the following disorders: intellectual disability, schizophrenia or other psychotic disorders, organic mental disorders, and neurodevelopmental disorders.
• For the clinical sample groups: adolescents with a principal diagnosis of anxiety disorder who also meet criteria for a conduct disorder, and vice versa (based on DSM-IV criteria)*.
• Consistent with the reclassification in DSM-5, obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) will be excluded from the category of anxiety disorders for the purpose of this research.
• For the no disorder group: participants who have previously accessed a child and/or adolescent service (government or private) for mental health treatment in the past 12 months.

*For this study, interested participants who meet DSM-IV criteria for both an anxiety disorder and conduct disorder will be excluded. This is to control for potential confounding variables presented by comorbid diagnoses and to clarify findings about treatment effects on specific subgroups of the population that are the target of this research, i.e. anxiety- and conduct-disordered adolescents. Those excluded due to not meeting full criteria can be provided with appropriate referrals to other support services.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis using G*Power 3.1 (Faul, Erdfelder, Lang, & Buchner, 2007, 2009) was used to determine the appropriate sample size required for this project. This was determined by setting a medium effect size f of .25 , alpha set at .05, and power at .80. It was estimated that a minimum of 98 participants (parent-adolescent pairs) in total will be required for this study. To allow for attrition across time, an additional 15% will be recruited meaning 114 participants with be recruited in total with at least 38 participants in each of the three sample groups. Adolescent and parent data will be matched to evaluate the quality of the parent-adolescent relationship and explore the research questions identified.

Quantitative data will be analysed using SPSS. Descriptive analyses will be used to describe the adolescents and parents participating in this project. Observation data from the video recordings of parent-adolescent interactions during the problem-solving tasks will be coded and categorised using an adapted version of the global scales from Hudson and Rapee’s (2001) study. Participants’ responses in the video-mediated recall exercise will be coded into categories using a coding system that will be developed for this task adapted from Sanders and colleagues’ video-mediated recall procedures (Halford & Sanders, 1988; Sanders & Dadds, 1992). Differences in variables between the three sample groups will be investigated using one-way analyses of covariance (ANCOVA) with age and gender selected as covariates. Specifically, differences in the constructs of connectedness and hostility between groups will be analysed. Correlations and regressions will be used to predict adolescent mental health outcomes from the parent-adolescent relationship, parenting behaviours and practices, and parental functioning. A series of repeated measures multivariate analyses of covariance (MANCOVA) will be used to assess for changes on the qualitative data and outcome measures at T2 and T3, with pre-intervention data at T1 included as covariates. MANCOVAS will be conducted on each set of conceptually related dependent variables, e.g. parent-adolescent relationship (PARS), adolescent functioning (AFS), parenting practices (APQ-9), and parental functioning (DASS-21; PPF).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2017
Actual
11/11/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
114
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 17821 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 297460 0
University
Name [1] 297460 0
The University of Queensland
Country [1] 297460 0
Australia
Primary sponsor type
University
Name
Parenting and Family Support Centre, The University of Queensland
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 296456 0
None
Name [1] 296456 0
Address [1] 296456 0
Country [1] 296456 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298566 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 298566 0
Ethics committee country [1] 298566 0
Australia
Date submitted for ethics approval [1] 298566 0
27/07/2017
Approval date [1] 298566 0
14/09/2017
Ethics approval number [1] 298566 0
2017001087

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2111 2111 0 0
/AnzctrAttachments/373608-2017001087 - Approval Form HRECB.pdf (Ethics approval)
Attachments [2] 2113 2113 0 0
/AnzctrAttachments/373608-CL03133_HREA Research Project Protocol FINAL.docx (Protocol)
Attachments [3] 2114 2114 0 0
/AnzctrAttachments/373608-PARTICIPANT INFORMATION SHEET & CONSENT FORM (parent) - FINAL.docx (Participant information/consent)
Attachments [4] 2115 2115 0 0
/AnzctrAttachments/373608-PARTICIPANT INFORMATION SHEET & CONSENT FORM (teenager) - FINAL.docx (Participant information/consent)

Contacts
Principal investigator
Name 77490 0
Ms Clarissa Lui
Address 77490 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane St Lucia QLD 4072
Country 77490 0
Australia
Phone 77490 0
+61 7 3443 2567
Fax 77490 0
+61 7 3365 6724
Email 77490 0
[email protected]
Contact person for public queries
Name 77491 0
Clarissa Lui
Address 77491 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane St Lucia QLD 4072
Country 77491 0
Australia
Phone 77491 0
+61 7 3443 2567
Fax 77491 0
+61 7 3365 6724
Email 77491 0
[email protected]
Contact person for scientific queries
Name 77492 0
Kylie Burke and Cassandra Dittman
Address 77492 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane St Lucia QLD 4072

Dr Kylie Burke: [email protected]
Dr Cassandra Dittman: [email protected]
Country 77492 0
Australia
Phone 77492 0
+61 7 3365 7306 or +61 7 3365 7303
Fax 77492 0
+61 7 3365 6724
Email 77492 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.