Condition category
Mental and Behavioural Disorders
Date applied
03/03/2011
Date assigned
11/05/2011
Last edited
08/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr George Westermann

ORCID ID

Contact details

Dr. H. van der Hoffplein 1
Sittard-Geleen
6162 BG
Netherlands
+31 (0)88 459 0340
g.westermann@orbisconcern.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL 21931.096.07 (CCMO the Netherlands)

Study information

Scientific title

Structured Shared Decision Making in Youth Mental Health Care to lower decisional conflict of parents and to promote acceptance of recommended treatment for their child compared with counselling as usual

Acronym

SSDM-YMHC

Study hypothesis

The use of a structured counselling procedure lowers decisional conflict and promotes acceptance of recommended treatment compared with counselling as usual

Ethics approval

Approved by the accredited Medical Research Ethics Committee Atrium-Orbis-Zuyd, Heerlen, The Netherlands on March 12 2008 (ref: METC nr: 08-T-18 CCMO nr: NL 21931.096.08)

Study design

Interventional multicentre randomised single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Counselling parents on child psychiatric disorders

Intervention

Counselling in dialogue (CD): a systematic counselling procedure using dialogue as communication style and visualisation as communication and information processing aid.

Parents of 78 children (up to12 years) were randomised into an intervention group (n = 43) receiving CD and a control group (n = 35) receiving CU. In a before-and-after design decisional conflict was measured using the Decisional Conflict Scale (DCS) for parents and the Provider Decision Process Assessment Instrument for therapists (PDPAI).
In the period May 2008-August 2009 all parents of children (up to 12 years) referred to two centres for general youth mental health care in the south of the Netherlands were asked to participate in the study. The parents of 131 children were assessed for eligibility. the parents of 110 children could be included. Parents of 94 children (85%) were randomised and the data of 81 cases (45 CD and 36 CU) could be analysed. Therapists (N = 20) were matched in pairs of two with regard to the following characteristics: the centre they work, their specialism, age, gender, country of birth, years of experience with counselling and therapy, and coping style with regard to decisional conflict. Subsequently they were randomised to be trained and to use CD or to proceed in their usually way of counselling (CU). Parents were randomly allocated to the therapists.

Randomisation for baseline assessment and demographic characteristics of the parents, and clinical features of the children was performed. Therapists were trained child and adolescent psychiatrists, psychologists, educationists, or mental health workers.

Parents and clinicians filled out questionnaires before the counseling, immediately after counselling, and one week after counseling. One month after all counseling sessions CD therapists filled out an evaluation questionnaire to rate their experiences with CD. If both parents attended counselling, both were asked to each fill out the questionnaires.

Joint/secondary sponsor details: St. Child and adolescent psychiatry in perspective
(St. Kinder- en jeugdpsychiatrie in Perspectief)
email: I.Demmendaal@erasmusmc.nl

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Decisional conflict in parents using the decisional conflict scale
2. Decisional conflict in therapists using the provider decision process assessment instrument

Measured before the counselling, immediately after counselling, and one week after counselling.

Secondary outcome measures

1. Qualitative aspects, judged by all participants
2. The possibilities to apply and implement counselling in dialogue

Overall trial start date

01/05/2008

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All parents (men and women) of children (age < 12 year) referred to the participating therapists of two youth mental health care centres who received counselling from May 2008 till August 2009

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

Emergency references and parents of children, aged 12 year or older

Recruitment start date

01/05/2008

Recruitment end date

31/07/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dr. H. van der Hoffplein 1
Sittard-Geleen
6162 BG
Netherlands

Sponsor information

Organisation

RIGG Hills and the Meuse (RIGG Heuvelland & Maasvallei) (Netherlands)

Sponsor details

Akerstraat 8
Maastricht
6221 CL
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

RIGG Hills and the Meuse (RIGG Heuvelland & Maasvallei) (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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23107362

Publication citations

  1. Results

    Westermann GM, Verheij F, Winkens B, Verhulst FC, Van Oort FV, Structured shared decision-making using dialogue and visualization: a randomized controlled trial., Patient Educ Couns, 2013, 90, 1, 74-81, doi: 10.1016/j.pec.2012.09.014.

Additional files

Editorial Notes