Condition category
Mental and Behavioural Disorders
Date applied
27/10/2011
Date assigned
02/12/2011
Last edited
30/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anxiety disorders are one of the most common mental disorders in pre-adolescent children. International prevalence rates range from 2.6% to 41.2%. This study examines whether there is a difference between a father or a mother helping their children overcome anxiety disorders by means of Cognitive Behavioral Parent Training (CBPT). The extent to whether changes in parents’ own anxiety, their parenting, and sense of parental competence are related to a reduction in children’s anxiety levels is investigated.

Who can participate?
Fathers and mothers of anxiety disorder children of 7-12 years old participated in the study.

What does the study involve?
Effectiveness of Father and Mother CBPT was compared and the training had the same format and content for fathers and mothers.

What are the possible benefits and risks of participating?
There were no risks to participants. The treatment of children’s anxiety disorders might have benefited from enrolling in the study.

Where is the study run from?
The study was run in the University of Amsterdam’s mental health clinic for children and parents (Netherlands).

When is the study starting and how long is it expected to run for?
Between November 2007 and April 2010.

Who is funding the study?
The study was funded by the Research Institute Child Development and Education, University of Amsterdam (Netherlands).
Who is the main contact?
Dr Corine van der Bruggen
c.o.vanderbruggen@uva.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Corine van der Bruggen

ORCID ID

Contact details

University of Amsterdam
Research Institute Child Development and Education
PO BOX 94208
Amsterdam
1090 GE
Netherlands
c.o.vanderbruggen@uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ecpow11-2007

Study information

Scientific title

Effects of targeting fathers versus mothers in cognitive behavioral parent training for parents of children with an anxiety disorder

Acronym

Study hypothesis

This study compares father cognitive behavioral parent training (CBPT) and mother CBPT for parents of children with an anxiety disorder, in order to investigate:
1. Whether father or mother CBPT is more effective in decreasing anxiety levels in children in the short and longer term
2. The extent to whether changes in parents’ own anxiety, their parenting, and sense of parental competence is related to a reduction in children’s anxiety levels in the short and longer term

Ethics approval

Ethics Commission of Child Development and Education, University of Amsterdam, 1 November 2007

Study design

A single centre interventional randomized controlled longitudinal trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not availabe in web format, please use the contact details below to request a patient information sheet

Condition

Childhood anxiety disorders

Intervention

The cognitive behavioral parent training (CBPT) is based on earlier work of Bögels and Siqueland (2006) and Bodden et al. (2008).

The training consists of 2 hour group meetings once a week for 6 weeks. Father and mother CBPT has the same format and content. Its main ingredients are:
1. Psycho-education
2. Challenging anxious thoughts
3. Exposure with a reward system
4. Parenting behaviors
5. Courageous modeling
6. Acting as a parent-team

The therapists ware trained clinical psychologists. The first follow-up period is 6 weeks, the second is 6 months after the CBPT finished.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Diagnostic status of the children using the Anxiety Disorder Interview Schedule Child and Parent versions (ADIS C/P) (Silverman & Albano, 1996). To consider change in the number of anxiety disorders and their interference their combination was examined (number of anxiety disorders × mean interference).
2. Children’s anxiety symptoms using the Screen for Child Anxiety Related Emotional Disorders (SCARED-71). Child, father, and mother completed the SCARED-71 (Bodden et al., 2009), and their reports were aggregated into an overall score for child anxiety symptoms.

Secondary outcome measures

1. Parenting behavior using the Parental Rearing Questionnaire (PRQ). Father and mother completed a self- and partner-report version of the subscales autonomy granting, overcontrol, and rejection of the PRQ (Bögels & Van Melick, 2004; new subscale structure Verhoeven, Bögels, Van der Bruggen, 2011). Self- and partner-report were aggregated into an overall score of parent’s autonomy granting, overcontrol, and rejection.
2. Challenging parenting behavior using the questionnaire Challenging Parenting Behavior (Majdandzic, De Vente, & Bögels, 2010). Father and mother completed a self- and partner-report version. Self- and partner-report were aggregated into an overall score of parent’s challenging behavior.
3. Parents' sense of competence using the Sense of Competence subscale of Parenting Stress Index (PSI; Abidin, 1983; De Brock, Vermulst, Gerris, & Abidin, 1992). Father and mother completed a self-report version.
4. Parents’ own anxiety using the Screen for Child Anxiety Related Emotional Disorders Adult version (SCARED-A; Bögels & Van Melick, 2004). Father and mother completed a self-report version.

Overall trial start date

01/11/2007

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Fathers and mothers of anxiety disorder children of 7-12 years old, referred or recruited by community announcement
2. The child having a primary anxiety disorder on the Anxiety Disorder Interview Schedule (ADIS) [Silverman & Albano, 1996]
3. Both parents willing and able to participate in CBPT

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21 fathers and 27 mothers of anxiety disorder children (26 boys and 22 girls)

Participant exclusion criteria

1. Prior child CBT and no parent treatment in relation to the child’s anxiety
2. Other severe psychiatric problems that might interfere with treatment

Recruitment start date

01/11/2007

Recruitment end date

01/05/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University of Amsterdam
Amsterdam
1090 GE
Netherlands

Sponsor information

Organisation

University of Amsterdam (UK)

Sponsor details

Research Institute Child Development and Education
PO BOX 94208
Amsterdam
1090 GE
Netherlands
s.m.bogels@uva.nl

Sponsor type

University/education

Website

http://www.english.uva.nl/

Funders

Funder type

University/education

Funder name

Research Institute Child Development and Education, University of Amsterdam (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes