Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000334101
Ethics application status
Approved
Date submitted
25/01/2019
Date registered
4/03/2019
Date last updated
4/10/2022
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent and Child Cognitive Behavioural Therapy for Anxiety Disorders
Scientific title
Concurrent Parent-Child Transdiagnostic Cognitive-Behavioural Therapy for Anxiety Disorders
Secondary ID [1] 297193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 311244 0
Condition category
Condition code
Mental Health 309864 309864 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is an open-label pilot trial including a qualitative and quantitative intervention evaluation. The intervention provided to participants (parent-child dyad) is a 10-week face-to-face cognitive behaviour therapy. Ten separate but concurrent parent and child treatment sessions will be provided in an individual format. One, 1 hour treatment session will occur each week, over 10 weeks. Treatment sessions will include relevant psychological education and the development of skills to best treat emotional symptoms. Treatment related homework tasks are expected to be completed in-between treatment sessions. Homework tasks are designed specifically based on the participants needs. Parent-child dyads will also be invited to participate in a qualitative interview following completion of the intervention to assess treatment acceptability. An additional treatment interested group will be interviewed to evaluate prospective acceptability.
The intervention and qualitative interviews will be delivered by doctoral-level students (provisional psychologists), with oversight from registered clinical psychologist with extensive experience in clinical practice and research. The intervention will be delivered at a university based psychology clinic. Qualitative interviews will be conducted online via a video-conferencing platform.
Intervention code [1] 313450 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318812 0
Adult/Parent Participants:
Examining the change in indices of anxiety severity from baseline and post-treatment. For adult parent participants, anxiety severity scores will be obtained from the Clinician Severity Rating in the Anxiety Diagnostic Interview Schedule Version 5 (ADIS-5).
Timepoint [1] 318812 0
Baseline, and within 4 weeks post-treatment.
Primary outcome [2] 318813 0
Child Participants:
Examining the change in indices of anxiety severity from baseline and post-treatment. For child participants, anxiety severity scores will be obtained from the Clinician Severity Rating in the Anxiety Diagnostic Interview Schedule Parent/Child Version 4 (ADIS-4 P/C).
Timepoint [2] 318813 0
Baseline, and within 4 weeks post-treatment.
Secondary outcome [1] 366131 0
Adult/Parent participants: Measure changes in parenting behaviours throughout treatment using pre- and post-treatment scores on the Parental Stress Scale.
Timepoint [1] 366131 0
Baseline and Week 10 of treatment.
Secondary outcome [2] 366718 0
Adult/Parent participants: Measure changes in parenting behaviours throughout treatment using pre- and post-treatment scores on the Parental Overprotection Measure.
Timepoint [2] 366718 0
Baseline and Week 10 of treatment.
Secondary outcome [3] 366782 0
Adult/Parent participants: Measure changes in parenting behaviours throughout treatment using pre- and post-treatment scores on the Parent Worry Measure.
Timepoint [3] 366782 0
Baseline and Week 10 of treatment.

Eligibility
Key inclusion criteria
Adult/Parent Participants:
Adult 18+ years of age, with a DSM-V primary diagnosis of an anxiety disorder, who has one child with a DSM-V primary diagnosis of an anxiety disorder.

Child Participants:
Primary school aged children (6-12 years) with a DSM-V primary diagnosis of an anxiety disorder, who has one parent with a DSM-V primary diagnosis of an anxiety disorder.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adult/Parent Participants:
-Primary DSM-V diagnosis other than an anxiety disorder.
-Inability to read and communicate in English sufficiently to understand and participate in assessment and treatment with English-speaking therapists.
-Evidence of dementia or other neurocognitive condition that might interfere with informed consent, or understanding and participating in treatment.
-Evidence of serious suicidality, current alcohol or illicit substance dependence, or any other condition of sufficient severity that requires immediate clinical prioritisation.

Child Participants:
-Primary DSM-V diagnosis other than an anxiety disorder.
-Inability to read and communicate in English sufficiently to understand and participate in assessment and treatment with English-speaking therapists.
-Evidence of a neurocognitive/neurodevelopmental condition that might interfere with understanding and participating in treatment.
-Evidence of serious suicidality or any other condition of sufficient severity that requires immediate clinical prioritisation.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Single group assignment for intervention.
Two groups for qualitative component - treatment involved and treatment interest groups.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/07/2019
Actual
12/09/2019
Date of last participant enrolment
Anticipated
Actual
15/07/2020
Date of last data collection
Anticipated
Actual
22/07/2020
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301761 0
University
Name [1] 301761 0
Monash University
Country [1] 301761 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Marie Yap
Address
Monash Psychology Centre
Building 1, 270 Ferntree Gully Road
Notting Hill, VIC.
AUSTRALIA, 3168
Country
Australia
Secondary sponsor category [1] 301678 0
None
Name [1] 301678 0
Address [1] 301678 0
Country [1] 301678 0
Other collaborator category [1] 280869 0
Individual
Name [1] 280869 0
Dr Katherine Lawrence
Address [1] 280869 0
Monash Psychology Centre
Building 1, 270 Ferntree Gully Road
Notting Hill, VIC.
AUSTRALIA, 3168
Country [1] 280869 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302469 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 302469 0
Wellington Road,
Clayton, VIC.
AUSTRALIA, 3800
Ethics committee country [1] 302469 0
Australia
Date submitted for ethics approval [1] 302469 0
21/09/2018
Approval date [1] 302469 0
29/11/2018
Ethics approval number [1] 302469 0
9781

Summary
Brief summary
The purpose of this study is to determine the acceptability and effectiveness of a newly developed parent-child cognitive behaviour therapy protocol for parents and their children who both have an anxiety disorder diagnosis. Ten separate parent and child group treatment sessions will be delivered. Treatment sessions will include relevant psychological education and the development of skills to best treat anxiety symptoms. It is anticipated that parent and child participants will find the treatment acceptable and show improvement in symptoms from pre-treatment to post-treatment. Findings from this study are expected to advance current understanding of effective treatment for parents and children with anxiety.
Trial website
Trial related presentations / publications
Public notes
Due to significant disruptions and restrictions related to the COVID-19 pandemic, the intervention component of the trial was suspended indefinitely. Consequently, three parent–child dyads (six participants) were withdrawn prior to completing the intervention.

Contacts
Principal investigator
Name 90326 0
A/Prof Marie Yap
Address 90326 0
Monash Psychology Centre
Building 1, 270 Ferntree Gully Road
Notting Hill, VIC.
AUSTRALIA, 3168
Country 90326 0
Australia
Phone 90326 0
+61 3 9902 4480
Fax 90326 0
+61 3 9905 0605
Email 90326 0
[email protected]
Contact person for public queries
Name 90327 0
Marie Yap
Address 90327 0
Monash Psychology Centre
Building 1, 270 Ferntree Gully Road
Notting Hill, VIC.
AUSTRALIA, 3168
Country 90327 0
Australia
Phone 90327 0
+61 3 9902 4480
Fax 90327 0
+61 3 9905 0605
Email 90327 0
[email protected]
Contact person for scientific queries
Name 90328 0
Marie Yap
Address 90328 0
Monash Psychology Centre
Building 1, 270 Ferntree Gully Road
Notting Hill, VIC.
AUSTRALIA, 3168
Country 90328 0
Australia
Phone 90328 0
+61 3 9902 4480
Fax 90328 0
+61 3 9905 0605
Email 90328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.