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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]

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

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

pre-treatment, post-treatment, and 6-month follow-up

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

25/01/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Balaclava Rd
Macquarie University
NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Ethics

Ethics committee address [1]

Macquarie University 
NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/09/2005

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Associate Professor Jennifer L. Hudson

Address

Department of Psychology
Balaclava Rd
Macquarie University
NSW 2109

Country

Australia

Phone

+61 2 9850 8668

Fax

[email protected]

Contact person for scientific queries

Name

Associate Professor Jennifer L. Hudson

Address

Department of Psychology
Balaclava Rd
Macquarie University
NSW 2109

Country

Australia

Phone

+61 2 9850 8668

Fax

[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

No additional documents have been identified.

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