Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000490077
Ethics application status
Approved
Date submitted
8/06/2010
Date registered
15/06/2010
Date last updated
25/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Efficacy of D-Cycloserine for Augmenting Exposure Therapy in Children with Spider Phobia and Dog Phobia: A Randomised Controlled Trial.
Scientific title
Among Spider and Dog Phobic Children is D-Cycloserine Augmented Exposure Therapy more Effective than Exposure Therapy alone as Measured by Performance on Behavioural Approach Tests.
Secondary ID [1] 251714 0
Not applicable.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spider phobia in children. Dog phobia in children. 257321 0
Condition category
Condition code
Mental Health 257463 257463 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Exposure Therapy Session for Spider Phobia or Dog Phobia + 50mg D-cycloserine Exposure Therapy: All children will receive a single graded exposure therapy session for their spider or dog phobia which last about three hours. A parent will be in the room throughout the treatment. During the treatment the child and therapist will “work as a team” to complete a “fear hierarchy” of steps that increase the child’s proximity or contact with a live, non-poisonous spider or dog (e.g. first step: stand 10 feet away from a boxed spider or leashed dog, final step: allow the spider to walk on your bare hand or pet the dog). At each step the therapist will model the actions or step that he wants the child to complete and then encourage the child to complete it them self. At each step the child will be asked to report their level of anxiety using a visual feeling thermometer. The therapist will encourage the child to remain at the step until they report at least a 50% reduction in their anxiety. The treatment will continue until the final step of the fear hierarchy is complete or the child does not wish to continue. The treatment involves little talking therapy, however , the therapist will encourage the child to draw conclusions regarding their safety after each step (e.g. “so did the spider attack you when you came close after all?”). The success of therapy is contingent upon the child’s co-operation and motivation throughout treatment. Therefore, the therapist will not make the child do anything he or she does not want to do. This is a clinically standard and empirically validated treatment for specific fears in children. D-Cycloserine: A single oral 50mg capsule of D-Cycloserine (DCS) administered 1 hour before exposure therapy.
Intervention code [1] 256441 0
Treatment: Drugs
Intervention code [2] 256442 0
Treatment: Other
Comparator / control treatment
Single Exposure Therapy Session for Spider or Dog Phobia + Placebo Exposure Therapy: All children will receive a single graded exposure therapy session for their spider or dog phobia which last about three hours. A parent will be in the room throughout the treatment. During the treatment the child and therapist will “work as a team” to complete a “fear hierarchy” of steps that increase the child’s proximity or contact with a live, non-poisonous spider or dog (e.g. first step: stand 10 feet away from a boxed spider or leashed dog, final step: allow the spider to walk on your bare hand, or pet the dog). At each step the therapist will model the actions or step that he wants the child to complete and then encourage the child to complete it them self. At each step the child will be asked to report their level of anxiety using a visual feeling thermometer. The therapist will encourage the child to remain at the step until they report at least a 50% reduction in their anxiety. The treatment will continue until the final step of the fear hierarchy is complete or the child does not wish to continue. The treatment involves little talking therapy, however , the therapist will encourage the child to draw conclusions regarding their safety after each step (e.g. “so did the spider attack you when you came close after all?”). The success of therapy is contingent upon the child’s co-operation and motivation throughout treatment. Therefore, the therapist will not make the child do anything he or she does not want to do. This is a clinically standard and empirically validated treatment for specific fears in children. Placebo: A single oral capsule (identical to the DCS capsule minus active ingredients) administered 1 hour before exposure therapy.
Control group
Placebo

Outcomes
Primary outcome [1] 258391 0
The primary outcome is the child's fear of spiders or dogs as measured by their performance on standardized Behavioral Avoidance Tests (BATs). BATs have a prescribed "fear hierarchy" of steps that increase proximity and/or contact with a live, non-poisonous spider or leashed dog (e.g. first step: stand 10 feet from the spider in a closed box or leashed dog, final step: allow the spider to walk on your bare hand or pet the dog). Measurements taken during the BATs include: 1. The number of fear hierarchy steps the child is able to complete. 2. The child's subjective report of anxiety for each BAT step as indicated on a 10 point feeling thermometer (0 = very relaxed, 10 = extremely scared). 3. The child's avergage heart rate measured at every step of the BAT achieved.
Timepoint [1] 258391 0
On the day of treatment:
1. A BAT will be conducted before the exposure treatment within the treatment context as a baseline measure of avoidance (BAT 1A).
2. A BAT will be conducted after the exposure treatment within the treatment context as a measure of treatment gain (BAT 2A).

On the day of the follow-up treatment, one week later:
3. A BAT will be conducted before follow-up treatment within the treatment context as a measure of treatment maintenance within treatment setting (BAT 3A).
4. A BAT will be conducted before follow-up treatment outside of the treatment context as a measure of treatment maintenance outside of the treatment setting (BAT 1B).
5. Finally, A BAT will be conducted after follow-up treatment outside of the initial treatment context as a measure of treatment gain outside of the treatment setting (BAT 2B).
Primary outcome [2] 258400 0
The child's fear of spiders or dogs will also be measured during the exposure treatment, which is like an extension of the standardized BAT. During the exposure treatment, a therapist will help the child complete the steps of the BAT by modelling the action or step he wants the child complete and then encouraging the child to partake. Measurements taken during the exposure treatment include: 1. The number of fear hierarchy steps the child is able to complete with therapist assistance. 2. The child's subjective report of anxiety for each BAT step as indicated on a 10 point feeling thermometer (0 = very relaxed, 10 = extremely scared).
Timepoint [2] 258400 0
Measurement will be taken during treatment and during follow-up treatment (one week later).
Secondary outcome [1] 264145 0
Child's self-report of Spider Phobia Questionnaire - Child Version or the child's self-report on Dog Phobia Questionnaire.
Timepoint [1] 264145 0
Baseline (before BAT 1A) and 1 week after treatment (before BAT 3A).
Secondary outcome [2] 264146 0
Parent and Child's self-report on the Spence Child Anxiety Scale.
Timepoint [2] 264146 0
Baseline (before BAT 1A) and 1 week after treatment (before BAT 3A).
Secondary outcome [3] 264147 0
Child's self-report on the Children's State-Trait Anxiety Inventory: "How I feel Now" Questionnaire.
Timepoint [3] 264147 0
Baseline (before BAT 1A) and 1 week after treatment (before BAT 3A).
Secondary outcome [4] 264391 0
Child's Self-Report on the Spider or Dogs Beliefs Questionnaire "Harm Subscale" (adpated for children).
Timepoint [4] 264391 0
Baseline (before BAT 1A) and before BAT 2A (before and after exposure treatment). One week after treatment (before BAT 3A) and after BAT 2B (before and after follow-up exposure treatment).
Secondary outcome [5] 264499 0
The child and parent will also record the amount of self-exposure to spiders or dogs and spider/dog-related anxiety.
Timepoint [5] 264499 0
This will be recorded in the week between treatment and follow-up.

Eligibility
Key inclusion criteria
A Diagnostic and Statistical Manual (4th ed.) diagnosis of Spider or Dog Phobia.
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The child must not have a comorbid diagnosis of Major Depressive Disorder, Pervasive Developmental Disorder or symptoms of Psychosis and/or Severe Anxiety (e.g. panic symptoms unrelated to spider phobia).

The child must not have a history of Epilepsy, Liver Disesase or Kidney Disease.

The child must not be taking any psychotropic medication (e.g. antidepressants, tranquilizing medications etc.).

The child must not be receiving additional psychotherapy for spider phobia.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256941 0
University
Name [1] 256941 0
Macquarie University
Country [1] 256941 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Psychology
Building C3A
Macquarie University, North Ryde, NSW (2109)
Country
Australia
Secondary sponsor category [1] 256207 0
None
Name [1] 256207 0
Address [1] 256207 0
Country [1] 256207 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259157 0
Macquarie University Human Research Ethics Committee.
Ethics committee address [1] 259157 0
Macquarie University, North Ryde, NSW (2109).
Ethics committee country [1] 259157 0
Australia
Date submitted for ethics approval [1] 259157 0
Approval date [1] 259157 0
23/08/2010
Ethics approval number [1] 259157 0
5201000753
Ethics committee name [2] 260541 0
New ethics name. Please modify.
Ethics committee address [2] 260541 0
New ethics address. Please modify.
Ethics committee country [2] 260541 0
Date submitted for ethics approval [2] 260541 0
Approval date [2] 260541 0
Ethics approval number [2] 260541 0
New ethics HREC. Please modify.

Summary
Brief summary
The aim of this trial is to examine whether 50mg of DCS can augment a single session of graded exposure therapy in children suffering from spider or dog phobia. The researchers are particularly interested in whether treatment gains can be maintained one week later both within and outside of the treatment context, as measured by Behavioral Approach Tests. The researchers hypothesize that children who receive the DCS in addition to exposure therapy will be less fearful of spiders or dogs one week later both within and outside of the treatment context.
Trial website
http://www.emotionalhealthclinic.com.au/index.cfm?page_id=1403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31139 0
Address 31139 0
Country 31139 0
Phone 31139 0
Fax 31139 0
Email 31139 0
Contact person for public queries
Name 14386 0
Mr Simon Byrne
Address 14386 0
Department of Psychology, Building C3A
Macquarie University, North Ryde, NSW (2109)
Country 14386 0
Australia
Phone 14386 0
+61 0415-202-957
Fax 14386 0
Email 14386 0
[email protected]
Contact person for scientific queries
Name 5314 0
Professor Ronald Rapee
Address 5314 0
Department of Psychology, Building C3A
Macquarie University, North Ryde, NSW (2109)
Country 5314 0
Australia
Phone 5314 0
+61 2 9850-8032
Fax 5314 0
+61 2 9850-8062
Email 5314 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
SourceTitleYear of PublicationDOI
Dimensions AID-CYCLOSERINE ENHANCES GENERALIZATION OF FEAR EXTINCTION IN CHILDREN2015https://doi.org/10.1002/da.22356
N.B. These documents automatically identified may not have been verified by the study sponsor.