Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000152426
Ethics application status
Approved
Date submitted
4/02/2016
Date registered
9/02/2016
Date last updated
17/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Building Bridges: Pilot Study of an Innovative Behavioural Family Intervention for Adolescents with Autism Spectrum Disorder.
Scientific title
Building Bridges: Pilot Study of an Innovative Behavioural Family Intervention for Adolescents with Autism Spectrum Disorder.
Secondary ID [1] 288480 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptoms of depression in carers 297522 0
symptoms of anxiety in carers 297523 0
symptoms of stress in carers 297524 0
adolescent behavioural problems 297525 0
dysfunctional parenting practices 297526 0
adolescent emotional problems 297527 0
Autism Spectrum Disorders 297541 0
Condition category
Condition code
Mental Health 297725 297725 0 0
Anxiety
Mental Health 297726 297726 0 0
Depression
Mental Health 297727 297727 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Building Bridges program consists of four 90-minute group sessions and four 30-minute follow-up telephone sessions over four weeks. Group and telephone sessions are open to carers of an adolescent with autism spectrum disorder. The four group sessions will be held weekly and will be strengthened by weekly telephone sessions. During both group and telephone sessions, topics such as understanding teenager’s behaviour, encouraging independence in teenagers, promoting positive interactions, managing problematic behaviour, helping teenagers to better manage their emotions and the importance of self care. Each group session will involve direct teaching components, rehearsal of skills, evaluation and homework exercises. Homework exercises include monitoring targeted behaviour and testing skills learnt in the group. It is envisaged that homework activities will not exceed 5 minutes per day. Potential participants will be recruited via a flyer displayed at various community and disability services in the Perth metropolitan area. Participants who express interest will undergo a 15-minute telephone screening interview to assess for eligibility. Participants who do not meet the exclusion criteria will be posted an information pack containing a confirmation of assessment letter, participant information sheet and consent form. Researchers will emphasise that all important carers in the adolescent’s life are encouraged to attend the intervention.
Prior to the assessment, participants will complete both the Family Background Questionnaire as well as the ABAS III to examine their adolescent’s level of adaptive functioning. In addition, the Social Communication Questionnaire will be completed to screen for ASD related symptoms. During the assessment session, participants will be assisted to commence completing their Parent Daily Report Checklists and Goal Achievement Scales. Participants will be invited to attend the first session where they will be required to complete the outcome measures (CAPES –DD, Parenting Scale, PAFAS- A and DASS-21) immediately pre- and post-intervention, and at three month follow up. Each family will receive a workbook detailing the key principles covered in each session and telephone support will be provided. Telephone support is provided to each family three days after each session and will consist of a 30 minute call to address any questions and solidify group learning. Both group and telephone sessions will be conducted by two provisionally registered psychologists who have received specialised support from Dr Trevor Mazzucchelli, an accredited Triple P trainer and clinical psychologist.
Register of attendance will be recorded in each client file, in the form of detailed client notes, to log both attendance at the group and participation in telephone sessions.
Intervention code [1] 293828 0
Behaviour
Intervention code [2] 293829 0
Prevention
Comparator / control treatment
No control group. All participants are exposed to the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297256 0
Severity of behaviour problems in adolescent, as measured by the Child Emotional and Child Behavioural Problems Scales of the Child Adjustment and Parent Efficacy Scale—Developmental Disability and the disruptive/antisocial, self-absorbed, communication disturbance, anxiety and social relating scales subscales of the Developmental Behaviour Checklist—Parent Version.
Timepoint [1] 297256 0
Baseline, one hour following cessation of intervention and at three months from cessation of intervention.
Primary outcome [2] 297257 0
Dysfunctional parenting practices as measured by the laxness, verbosity, and overreactivity scales of the Parenting Scale.
Timepoint [2] 297257 0
Baseline, one hour following cessation of intervention and three months following cessation of intervention
Primary outcome [3] 297258 0
Symptoms associated with depression, anxiety and stress as measured by the on the Depression, Anxiety and Stress Scales—21.
Timepoint [3] 297258 0
Baseline, one hour following cessation of intervention and at three months from cessation of intervention.
Secondary outcome [1] 320484 0
Each family meeting their individual goals as measured by individual Goal Achievement Scales.
Timepoint [1] 320484 0
Baseline, one hour following cessation of intervention and at three months following cessation of intervention.
Secondary outcome [2] 320485 0
Carer confidence in managing their adolescent’s behaviour as measured by the Parent Efficacy Scale of the Child Adjustment and Parent Efficacy Scale—Developmental Disability.
Timepoint [2] 320485 0
Baseline, one hour following cessation of intervention and at three months following cessation of intervention.
Secondary outcome [3] 320486 0
Family dysfunction, as measured by the family dysfunction scale of the Parenting and Family Adjustment Scales.
Timepoint [3] 320486 0
Baseline, one hour following cessation of intervention and at three months following cessation of intervention.

Eligibility
Key inclusion criteria
The eligibility criteria for participation will be that the participant is a parent or carer of an adolescent aged 12 to 16 years who has received a diagnosis of ASD. A specialist or certified health professional (e.g., paediatrician) must have confirmed the adolescent’s primary diagnosis to meet criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The nature of the group requires that participants demonstrate adequate literacy ability (e.g., able to read a newspaper without assistance) and this will be assessed during screening. Families who have attended a Triple P intervention group in the previous month, or who are consulting another professional for their adolescent’s problematic behaviour, will be excluded from the study. However, participants who are not eligible will be directed to appropriate alternative supports. Parents and carers who report experiencing major psychopathology, including bipolar disorder, schizophrenia or those at high risk of suicide or self-harm will be excluded from the study. In the case of a participant presenting with significant self-harm or suicide risk, suicide risk assessment guidelines (NSW Department of Health, 2004; Crisis Support Services, 2005) and clinic safety procedures will be enacted. Individuals will be directed to appropriate support services and follow up contact will be provided.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2016
Actual
9/03/2016
Date of last participant enrolment
Anticipated
18/05/2016
Actual
15/05/2016
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
8
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292824 0
University
Name [1] 292824 0
Research Allocation Fund (RAF) grant, Curtin University
Country [1] 292824 0
Australia
Primary sponsor type
Individual
Name
Dr Trevor Mazzucchelli
Address
Faculty of Health Sciences, School of Psychology and Speech Pathology, Curtin University, Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 291567 0
Individual
Name [1] 291567 0
Marian Jenkins
Address [1] 291567 0
Curtin University, Kent Street, Bentley WA 6102
Country [1] 291567 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294331 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 294331 0
Ethics committee country [1] 294331 0
Australia
Date submitted for ethics approval [1] 294331 0
14/12/2015
Approval date [1] 294331 0
24/02/2016
Ethics approval number [1] 294331 0
HR24/2016

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

Contacts
Principal investigator
Name 63286 0
Dr Trevor Mazzucchelli
Address 63286 0
Faculty of Health Sciences, School of Psychology and Speech Pathology, Curtin University, Kent Street, Bentley WA 6102
Country 63286 0
Australia
Phone 63286 0
+618 92667182
Fax 63286 0
Email 63286 0
[email protected]
Contact person for public queries
Name 63287 0
Marian Jenkins
Address 63287 0
Faculty of Health Sciences, School of Psychology and Speech Pathology, Curtin University, Kent Street, Bentley WA 6102
Country 63287 0
Australia
Phone 63287 0
+61 423 514 221
Fax 63287 0
Email 63287 0
[email protected]
Contact person for scientific queries
Name 63288 0
Trevor Mazzucchelli
Address 63288 0
Faculty of Health Sciences, School of Psychology and Speech Pathology, Curtin University, Kent Street, Bentley WA 6102
Country 63288 0
Australia
Phone 63288 0
+618 92667182
Fax 63288 0
Email 63288 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.