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Trial registered on ANZCTR


Registration number
ACTRN12618001601224
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
26/09/2018
Date last updated
18/02/2019
Date data sharing statement initially provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Single Session Treatment for Specific Phobias in Pre-School Aged Children
Scientific title
One-Session Treatment for Specific Phobias in Pre-School Children: Improving access and long-term mental health outcomes
Secondary ID [1] 295648 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Specific Phobia 308985 0
Condition category
Condition code
Mental Health 307888 307888 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One-session treatment (OST) for specific phobias involves a single 3-hour session of cognitive-behaviour therapy (CBT). CBT involves education, gradual exposure to the child's phobic situation/object, participant modeling, reinforced practice, cognitive challenging through behavioural experiments, and reinforced practice. Given the children receiving treatment are young (3-5 years), play therapy techniques will also be implemented to enhance engagement and motivation for exposure therapy, including child directed free play, use of sentence stems and play sequences to provide eduaction and elicit child's phobic thoughts. Therapy is delivered by trained graduate students who are provisionally registered psychologists and undertaking post-graduate training in clinical psychology training. Treatment occurs at the clinic or in the participants home. The therapy is manualised and treatment procedures standardized across participants, however, tailored to address each child's individual fears and phobia.
Intervention code [1] 301964 0
Treatment: Other
Comparator / control treatment
2 comparison groups: 6 months waitlist control and Education Support Treatment (EST; 3 hours of education about fear and anxiety). Education Support Treatment involves psychoeducation delivered to parents and child on the nature of fear and phobias. Therapy is delivered by trained graduate students who are provisionally registered psychologists and undertaking post-graduate training in clinical psychology training. Treatment occurs at the clinic and is manualised and standardized for all children.
Control group
Active

Outcomes
Primary outcome [1] 306857 0
Specific phobia diagnostic status based on the Anxiety Disorders Interview Schedule - parent version (ADIS-P) and Clinician Severity Rating
Timepoint [1] 306857 0
post-treatment and 6 months following treatment
Primary outcome [2] 306858 0
Behavioural Approach Task
Timepoint [2] 306858 0
post-treatment and 6 months following treatment
Primary outcome [3] 306859 0
Parent Rated Target Symptoms - the child's top 3 phobia symptoms, rated on a Likert scale (0 to 8) for How Fearful the child is of the stimuli (e.g., patting a dog)
Timepoint [3] 306859 0
post-treatment and 6 months following treatment
Secondary outcome [1] 349961 0
Parent Rated Anxiety using the Preschool Anxiety Scale (Spence).
Timepoint [1] 349961 0
6 months following treatment
Secondary outcome [2] 349962 0
Child Rated Fear, using the Koala Fear Survey (Muris)
Timepoint [2] 349962 0
6 months following treatment
Secondary outcome [3] 349963 0
Presence of comorbid disorders as measured by the Anxiety Disorders Interview Schedule - parent version (ADIS-P)
Timepoint [3] 349963 0
6 months following treatment, and 12 months following treatment

Eligibility
Key inclusion criteria
(1) child aged 3 to 5 years; (2) current diagnosis of specific phobia; (3) willingness to cease concurrent psychotherapy; (4) parent willing to participate in therapy and assessments
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) child with a non-anxiety primary diagnosis; (2) comorbid autism (level 2 or 3) or other pervasive developmental disorder; (3) suspected intellectual disability or speech and language disorder; and (4) current use of psychotropic medication

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)
Allocation concealed - allocation involves contacting the holder of the allocation schedule who is "off-site" and does not have any other direct role with the research team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on our previous trials, we have observed moderate effects (Cohen’s d= 0.46) for OST relative to EST on phobic severity (CSR; 0.88 point difference) at 26 weeks (much larger ES at post-OST, d = .82; and between OST and WC at post-OST, d = 1.38). Thus, we take an estimate of effect of 0.45 (Cohen’s d) for between group differences on the phobic severity (CSR) at 6 months. With power (1-ß) set at 0.80, alpha (a) set at .05, and a two-tailed test, we calculate that we would need a sample size of 76 per group for EST and OST. To allow for attrition (<10% across OST and EST based on all of our past trials, but likely more from the WC despite CIB having 0% attrition in his WC at 6 months) we will recruit a total of 208 (83 OST; 83 EST and 42 WC) and can tolerate ~30% attrition from the WC (require n=32 for 80% power at d=0.90).
Statistical analyses will be done in accordance with the International Conference on Harmonization E9 statistical principles, and will be based on all randomised participants who commence treatment (intention-to-treat). The primary efficacy analysis will assess treatment group differences for primary outcome measures (CSR, CGAS, BAT) at primary end point (6 month follow-up) and will use a likelihood based mixed-effects model, repeated measures approach. The model includes the fixed, categorical effects of treatment, and treatment-by-time interaction. Site will also be included as a fixed effect. A secondary efficacy analysis assesses treatment group differences for primary outcomes (CSR, CGAS), as well as comorbidity (internalising and externalising symptoms) over long-term follow-up (12 and 24 months). The multi-level modelling approach includes all available data at each time and is the preferred method of analysing clinical trial data. Planned comparisons will be done within the model to determine between group differences in change on symptoms from baseline to week 26, and from week 26 to end point (week 52). To answer the secondary study aim, which is to build a model to identify participants most likely to benefit from the program, we will first identify 10-20 candidate predictor variables for inclusion in the model. Univariable associations between candidate predictor variables and the outcomes of response and remission will be investigated using logistic regression. Variables likely to be relevant in predicting response and potentially included in the model based on a priori expectation include (among others): somatic symptoms, externalizing symptoms, maternal depression. Multivariable analysis will be performed to determine the most appropriate combination of predictors. Interaction terms will be tested between treatment received and all candidate variables, as well as between candidate variables if effect modification is considered to be likely based on previous literature. The final model will be selected using the Bayesian information criterion. Model calibration will be tested graphically and using the Hosmer-Lemeshow statistic. Internal validation will be performed using bootstrap resampling; we will estimate the model bias due to overfitting and correct the final model accordingly.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
9/10/2018
Date of last participant enrolment
Anticipated
1/01/2021
Actual
Date of last data collection
Anticipated
1/01/2023
Actual
Sample size
Target
208
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23525 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 300228 0
Government body
Name [1] 300228 0
National Health and Medical Research Council
Country [1] 300228 0
Australia
Primary sponsor type
Individual
Name
A/Prof Lara Farrell
Address
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 299639 0
Individual
Name [1] 299639 0
Prof Thomas Ollendick
Address [1] 299639 0
Virginia Polytechnic Institute and State University
Blacksburg, VA 24061, USA
Country [1] 299639 0
United States of America
Secondary sponsor category [2] 299641 0
Individual
Name [2] 299641 0
Caroline Donovan
Address [2] 299641 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus
176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country [2] 299641 0
Australia
Secondary sponsor category [3] 299642 0
Individual
Name [3] 299642 0
Sue Spence
Address [3] 299642 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus
176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country [3] 299642 0
Australia
Secondary sponsor category [4] 299643 0
Individual
Name [4] 299643 0
Allison Waters
Address [4] 299643 0
School of Applied Psychology, Griffith University, Mt Gravatt Campus
176 Messines Ridge Rd, Mount Gravatt QLD 4122
Country [4] 299643 0
Australia
Secondary sponsor category [5] 299644 0
Individual
Name [5] 299644 0
Melanie Zimmer-Gembeck
Address [5] 299644 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country [5] 299644 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301051 0
GRIFFITH UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 301051 0
Ethics committee country [1] 301051 0
Australia
Date submitted for ethics approval [1] 301051 0
01/02/2018
Approval date [1] 301051 0
11/04/2018
Ethics approval number [1] 301051 0
GU Ref No: 2018/145

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

Contacts
Principal investigator
Name 85714 0
A/Prof Lara Farrell
Address 85714 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country 85714 0
Australia
Phone 85714 0
+61 75678 8317
Fax 85714 0
Email 85714 0
l.farrell@griffith.edu.au
Contact person for public queries
Name 85715 0
Lara Farrell
Address 85715 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country 85715 0
Australia
Phone 85715 0
+61 75678 8317
Fax 85715 0
Email 85715 0
l.farrell@griffith.edu.au
Contact person for scientific queries
Name 85716 0
Lara Farrell
Address 85716 0
School of Applied Psychology, Griffith University
Parklands Dr, Southport QLD 4215
Country 85716 0
Australia
Phone 85716 0
+61 75678 8317
Fax 85716 0
Email 85716 0
l.farrell@griffith.edu.au

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


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.