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Trial registered on ANZCTR


Registration number
ACTRN12612000139875
Ethics application status
Approved
Date submitted
31/01/2012
Date registered
1/02/2012
Date last updated
13/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot investigation of an online, parent-only Cognitive Behaviour Therapy (CBT) intervention for preschool children with anxiety.
Scientific title
Is an online Cognitive Behaviour Therapy (CBT) intervention delivered to parents effective in reducing anxiety and related symptoms in preschool aged children?
Secondary ID [1] 279744 0
None
Universal Trial Number (UTN)
U1111-1127-1161
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety in preschool aged children 285602 0
Condition category
Condition code
Mental Health 285796 285796 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes Cognitive Behaviour Therapy (CBT) anxiety management strategies delivered to parents, and includes: psychoeducation, relaxation training, recognition of the physiological symptoms of anxiety, cognitive strategies of coping self-talk and cognitive restructuring, graded exposure, problem solving, and self-reinforcement. The sessions also teach parenting strategies to empower parents to help their children implement anxiety management skills.

The intervention consists of the parent program of BRAVE-ONLINE and will include six, one-hour online sessions for parents, completed over a 10-week period. Booster sessions are completed at one- and three-months following treatment. The parent program of BRAVE-ONLINE was originally developed for children aged from eight years, and their parents. For the purposes of this pilot study, handouts were provided to parents in order to make the examples and situations presented in the program, age appropriate for preschool children.

Sessions are designed to be engaging and interactive. Eye-catching graphics, sounds, games and quizzes are used to maintain interest. Information is presented through interactive exercises and followed by quizzes that check for correct understanding and provide personalized corrective or positive feedback through pop-up messages. The content of the intervention is suitable for the parents of school aged children and the supplementary handouts provide age-appropriate scenarios, examples, and activities for preschool aged children. Examples of scenarios presented include starting preschool or kindergarten, or meeting new children at playgroup.

The program is (minimally) therapist-assisted, rather than self-help. Each family is assigned an online therapist (BRAVE Trainer) who monitors their progress through the program and provides brief email feedback following each session. At no stage do any participants have face-to-face contact with their therapist and all other contact (i.e., email or phone) is minimal. Clinician contact is restricted to brief, weekly emails. Most other contact with the ‘online therapist’ is computer generated. Client responses to all session and homework activities are stored in an administrator section of the program and can be viewed by the therapist to guide the content of the weekly email. In addition, automated computer-generated emails are sent on behalf of the online therapist to congratulate participants for completion of sessions and personalized emails are sent to provide feedback about responses to quiz tasks. Personalized automated reminder emails are sent to advise when the next session is available for completion, or to provide prompts if not completed by the due date.

The wait list control condition will complete the pre-treatment assessment and will then be reassessed after 10-weeks. After this point they will be offered treatment by the research team.
Intervention code [1] 284057 0
Behaviour
Comparator / control treatment
There is one active treatment and a wait list control condition in this study. The wait list control condition will complete the pre-treatment assessment and will then be reassessed after 10-weeks. After this point they will be offered the same BRAVE-ONLINE treatment as delivered to the active treatment group.
Control group
Active

Outcomes
Primary outcome [1] 286308 0
The primary outcome measure includes "blind", independent clinical diagnostic interviews for anxiety disorders and clinician severity ratings of diagnoses using the Anxiety Disorders Interview Schedule for DSM-IV: Parent version (ADIS-P)
Timepoint [1] 286308 0
Pre-treatment
10-weeks
6-month follow-up
Primary outcome [2] 286309 0
Overall adaptive functioning using the Children's Global Assessment Scale (CGAS: Schaffer et al., 1983). The CGAS provides a single global rating of functioning, assigned to the child by the independent, interviewing clinician, on a scale of 0 to 100, where lower scores indicate poorer functioning. A rating is given based on the child's most impaired level of general functioning for the specified time period by selecting the lowest level which describes his/her functioning on a hypothetical continuum of health-illness, benchmarked against anchor points in a descriptive glossary.
Timepoint [2] 286309 0
Pre-treatment
10-weeks
6-month follow-up
Secondary outcome [1] 295581 0
Internalizing problems using the internalising scale of the Child Behaviour Checklist for Ages 1.5 - 5 (Achenbach)
Timepoint [1] 295581 0
Pre-treatment
10-weeks
6-month follow-up
Secondary outcome [2] 295582 0
Assessment of parental levels of depression, anxiety and stress will be measured using the Depression, Anxiety and Stress Scale (DASS-21, Lovibond & Lovibond, 1995)
Timepoint [2] 295582 0
Pre-treatment
10-weeks
6-month follow-up
Secondary outcome [3] 295583 0
Assessment of parenting style will be measured using the Egna Minnen Betraffande Uppfostran (EMBU-P, Castro et al., 1996)
Timepoint [3] 295583 0
Pre-treatment
10-weeks
6-month follow-up
Secondary outcome [4] 295584 0
Parental satisfaction with the program will be measured using the Parent Satisfaction Questionnaire (PSQ)
Timepoint [4] 295584 0
10-weeks
Secondary outcome [5] 295585 0
The overall functioning of the parent will be measured using the Overall Functioning measure (OF)
Timepoint [5] 295585 0
10-weeks
6-month follow-up
Secondary outcome [6] 295586 0
Therapy compliance measures, computer generated: number of sessions completed; frequency of sessions; number and quality of completed homework assignments; number and quality of session activities completed; time spent on sessions.
Timepoint [6] 295586 0
After each session
Secondary outcome [7] 295772 0
Child anxiety will be measured using the Pre-school Anxiety Scale (PAS, Spence et al., 2001)
Timepoint [7] 295772 0
Pre-treatment
10-weeks
6-month follow-up

Eligibility
Key inclusion criteria
Participants (of any age) will be included in the study if they have pre-school aged children (3-5 years at the time of intake) who meet DSM-IV criteria for a primary diagnosis of an anxiety disorder with a clinical severity rating (CSR) of at least 4 (on a 0-8 scale). Comorbidity with externalising disorders will be permissible as long as anxiety is considered primary. Families must have access to a suitable computer and the internet, and be willing to participate in either condition.
Minimum age
0 Years
Maximum age
0 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a pervasive developmental disorder will be excluded. For ethical reasons pertaining to the danger of potential self-harm, children with clinical levels of depression (Clinician Severity Rating of 4 or higher on a 0-8 scale on the ADIS-P) will not be included in the program and will be referred elsewhere for assistance. There are no exclusion criteria for their parents.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Families will be recruited Australia-wide through referrals from general practitioners, mental health professionals, school guidance officers, and media publicity. Self referrals will be accepted. Referrals will be screened by telephone using a standard screening interview in order to ascertain broad inclusion criteria. Following informed consent, the parent will complete a structured diagnostic interview (the ADIS-P) to determine clinical status. Parents of eligible children will then be randomly assigned to one of two conditions (treatment or the wait list). Assessors will be trained clinical interviewers who will be independent of other aspects of the study and blind to allocated condition. Random assignment of participants to conditions will be conducted using a computer generated random number sequence. The clinician who will make the judgement regarding acceptance into the trial will not be aware of the condition to which the client would subsequently be allocated to, thus allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence will be used for allocation of participants to either condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants in this pilot study will be followed-up over 6 months time. The study will also enable us to examine predictors of therapy outcome, such as initial severity of symptoms, gender and age of child.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2010
Actual
11/08/2011
Date of last participant enrolment
Anticipated
Actual
11/08/2011
Date of last data collection
Anticipated
Actual
11/12/2011
Sample size
Target
40
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 284528 0
Government body
Name [1] 284528 0
Rotary
Country [1] 284528 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
Nathan campus
Kessels Rd., Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 283457 0
University
Name [1] 283457 0
University of Queensland
Address [1] 283457 0
University of Queensland St Lucia
Brisbane
Queensland
QLD 4067
Country [1] 283457 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286513 0
Griffith University HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 286513 0
Ethics committee country [1] 286513 0
Australia
Date submitted for ethics approval [1] 286513 0
Approval date [1] 286513 0
10/02/2010
Ethics approval number [1] 286513 0
PSY/E3/09/HREC
Ethics committee name [2] 286599 0
University of Queensland Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [2] 286599 0
Ethics committee country [2] 286599 0
Australia
Date submitted for ethics approval [2] 286599 0
Approval date [2] 286599 0
19/01/2010
Ethics approval number [2] 286599 0
2009001877

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

Contacts
Principal investigator
Name 33641 0
A/Prof Caroline Donovan
Address 33641 0
School of Applied Psychology
Griffith University
Mt Gravatt Campus,
Messines Ridge Rd,
Mt Gravatt, QLD, 4122
Country 33641 0
Australia
Phone 33641 0
+61 7 37353401
Fax 33641 0
Email 33641 0
c.donovan@griffith.edu.au
Contact person for public queries
Name 16888 0
Dr Caroline Donovan
Address 16888 0
School of Applied Psychology
Mt Gravatt Campus, Griffith University
176 Messines Ridge Rd
Mt Gravatt, Queensland, 4122
AUSTRALIA
Country 16888 0
Australia
Phone 16888 0
+61 7 37353401
Fax 16888 0
+61 7 37353388
Email 16888 0
c.donovan@griffith.edu.au
Contact person for scientific queries
Name 7816 0
Dr Caroline Donovan
Address 7816 0
School of Applied Psychology
Mt Gravatt Campus, Griffith University
176 Messines Ridge Rd
Mt Gravatt, Queensland, 4122
AUSTRALIA
Country 7816 0
Australia
Phone 7816 0
+61 7 37353401
Fax 7816 0
+61 7 37353388
Email 7816 0
c.donovan@griffith.edu.au

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.