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Trial registered on ANZCTR


Registration number
ACTRN12611000860965
Ethics application status
Approved
Date submitted
12/08/2011
Date registered
12/08/2011
Date last updated
12/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of parental anxiety management on child anxiety treatment outcomes: a controlled trial.
Scientific title
Parental anxiety management versus no parental anxiety management as an adjunct to cognitive behaviour therapy for childhood anxiety disorders: changes in anxiety diagnosis and anxiety symptoms.
Secondary ID [1] 262822 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorders in children and parents 270545 0
Condition category
Condition code
Mental Health 270703 270703 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parental Anxiety Management (PAM) for experimental group. This program is based on cognitive behavioural therapy, 5 x 40mins sessions delivered in a group format, once per fortnight. The treatment components included: psychoeducation, cognitive restructuring, time management, problem-solving, and gradual exposure for the parents. ALL children and families received cognitive behavioural therapy [Cool Kids treatment program (Rapee, Wignall, Hudson, and Schniering, 2000)] 10 x 2 hour sessions delivered in group format, once a week. These sessions included psychoeducation, cognitive restructuring, problem-solving, assertiveness training, and gradual exposure. Both parents and children were involved in the Cool Kids treatment program. For families randomly assigned to the PAM group, the PAM program was conducted simultaneously with the Cool Kids treatment program over the 10-week period. For families that were randomly assigned to the PAM program, the program was offered to both parents. Moreover, both anxious and non-anxious parents were randomly allocated to the PAM program.
Intervention code [1] 269171 0
Treatment: Other
Intervention code [2] 269174 0
Behaviour
Comparator / control treatment
No Parental Anxiety Management group (No PAM or CBT only group): This group completed the Cool Kids but the parents in this group did not receive the parental anxiety management program.
Control group
Active

Outcomes
Primary outcome [1] 269418 0
Presence/absence of anxiety disorder assessed by the Anxiety Disorder Interview Schedule for Children (ADIS-IV-C/P; Silverman & Albano, 1996). Presence/absence of anxiety disorder assessed by the ADIS for the parents' anxiety difficulties (ADIS-IV; Brown, Di Nardo, & Barlow, 1994).
Timepoint [1] 269418 0
pre-treatment, post-treatment, and 6-month follow-up
Secondary outcome [1] 287590 0
Parental and child reported anxiety symptoms:

Spence Children's Anxiety Scale (Spence, 1998) for the child's anxiety

Depression Anxiety Stress Scale - 21 Items (Lovibond & Lovibond, 1995) for the parent's anxiety
Timepoint [1] 287590 0
pre-treatment, post-treatment, and 6-month follow-up

Eligibility
Key inclusion criteria
principal anxiety disorder for the child
Minimum age
6 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual and developmental disability, psychoses, disabling medical condition and concurrent psychological treatment. Youths with co-morbid behavioral disorders who had a clinical severity rating of 6 or more were also excluded.

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)
Following a brief telephone screen, parents signed consent forms at the assessment and children provided verbal assent. Children who met criteria for inclusion and agreed to participate were allocated to a group based on the child's age. Allocation was concealed: clinicians determined the child's eligibility for the study and then the clinic administration team conteacted the research officer who held the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The first author used a schedule from a random number generator (computer software obtained online) to assign each group to treatment condition and to therapists.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269646 0
Government body
Name [1] 269646 0
National Health and Medical Research Council
Address [1] 269646 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 269646 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 266678 0
None
Name [1] 266678 0
Address [1] 266678 0
Country [1] 266678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269594 0
Macquarie University Human Ethics
Ethics committee address [1] 269594 0
Macquarie University
NSW 2109
Ethics committee country [1] 269594 0
Australia
Date submitted for ethics approval [1] 269594 0
Approval date [1] 269594 0
23/09/2005
Ethics approval number [1] 269594 0
HE23SEP2005-R04293

Summary
Brief summary
Objective: The current trial examined whether the inclusion of a parental anxiety management (PAM) program in addition to family cognitive-behavioral therapy (CBT) was more efficacious than family CBT only in treating childhood anxiety disorders. Method: Two hundred and nine children (aged 6-13 years) with a principal anxiety disorder were randomly allocated to a 5 session PAM program (n = 109) in addition to family CBT or family CBT only. Results: Overall, results revealed that the addition of PAM did not significantly improve principal anxiety diagnostic outcomes for the child or the parent compared to the CBT only group at post-treatment and 6-month follow-up. Results further suggest that children with non-anxious parents were more likely to be diagnosis-free for any anxiety disorder compared to children with anxious parents at post-treatment and 6-mth follow-up. Conclusions: The present findings indicate that the addition of PAM in its current format did not lead to additional gains in diagnostic status when used as an adjunct to family CBT in the treatment of the child’s anxiety disorder. The addition of PAM did not lead to a sufficient decline in parental anxiety disorders over and above the decline observed across time for children receiving CBT. Parental anxiety status impacted on child diagnostic outcome: Children were less likely to be diagnosis-free following treatment if they had a parent who also had an anxiety disorder.
Trial website
Trial related presentations / publications
Hudson, J.L., Rapee, R.M., Lyneham, H.J., Wuthrich, V., Edwards, S., Seeley, E., & Gar, N. (September, 2009). Treating parent anxiety to enhance the efficacy of cognitive behavioural treatment for children with anxiety disorders. Paper presented at the Australian Association for Cognitive and Behaviour Therapy, Perth, Australia.

Rapee, R.M., Hudson, J.L., Schniering, C.A., Lyneham, H.J., Wuthrich, V., Edwards, S.,Seeley, E., & Gar, N. (November, 2008). Treating parent anxiety to enhance the efficacy of cognitive behavioural treatment for children with anxiety disorders. Paper presented at the Association for Behavioral & Cognitive Therapies, Orlando, FL

Hudson, J.L., Rapee, R.M., Lyneham, H.J., Wuthrich, V., Edwards, S., Seeley, E., & Gar, N. (September 2011). Treating parent anxiety to enhance the efficacy of family-based cognitive behavioural treatment for childhood anxiety disorders. Paper to be presented at The European Association for Behavioural and Cognitive Therapies, Reykjavik, Iceland.
Public notes

Contacts
Principal investigator
Name 33008 0
Address 33008 0
Country 33008 0
Phone 33008 0
Fax 33008 0
Email 33008 0
Contact person for public queries
Name 16255 0
Associate Professor Jennifer L. Hudson
Address 16255 0
Department of Psychology
Balaclava Rd
Macquarie University
NSW 2109
Country 16255 0
Australia
Phone 16255 0
+61 2 9850 8668
Fax 16255 0
Email 16255 0
jhudson@psy.mq.edu.au
Contact person for scientific queries
Name 7183 0
Associate Professor Jennifer L. Hudson
Address 7183 0
Department of Psychology
Balaclava Rd
Macquarie University
NSW 2109
Country 7183 0
Australia
Phone 7183 0
+61 2 9850 8668
Fax 7183 0
Email 7183 0
jhudson@psy.mq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary