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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23107362
Publication citations
-
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.