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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 7 November 2016
Main ID:  ISRCTN65931294
Date of registration: 12/10/2016
Prospective Registration: No
Primary sponsor: Health Sciences Research Ethics Board - The University of Western Ontario
Public title: Effectiveness study of the "Practitioner Training in Child and Adolescent Psychiatry" program for rural primary care providers
Scientific title: Efficacy Trial of the "Practitioner Training in Child and Adolescent Psychiatry": An Educational Intervention to Enhance Paediatric Mental Health Practice and Outcomes in Rural Primary Care
Date of first enrolment: 01/12/2014
Target sample size: 300
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN65931294
Study type:  Interventional
Study design:  Multi-centre unblinded stratified cluster randomized controlled trial (Treatment)  
Phase: 
Countries of recruitment
Canada
Contacts
Name: Stacey     Espinet
Address:  1151 Richmond St The University of Western Ontario Centre for Education Research & Innovation Health Sciences Addition Room 110 N6A 5C1 London Canada
Telephone:
Email:
Affiliation: 
Name: Sandra     Gotovac
Address:  Child & Adolescent Mental Health Care Program, Children’s Hospital, London Health Sciences Center, B8-159 800 Commissioners Rd E N6A 5W9 London Canada
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Inclusion criteria for primary care providers:
1. Practicing as a Primary Care Practitioners (PCPs) i.e. a family medicine resident; family physician, nurse practitioner, paediatrician
2. Emplyed at a family practice site (i.e. a family health team, community health center, private practice
3. Located in a rural region (population under 100,000, where 0 to 30% of the population commutes to work in a large urban center; Pong & Pitblado, 2005) of Southwestern Ontario

Inclusion criteria for families:
1. Parent of at least one child/youth aged 6 to 18 years
2. The parent was attending a medical visit at a participating site with a participating or non-participating practitioner, with or without the target child/youth

Exclusion criteria: There are no exclusion criteria for PCPs or families

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Child and youth mental health
Mental and Behavioural Disorders
1. Attention Deficit with Hyperactivity Disorder (ADHD) 2. Behavioral disorders 3. Anxiety 4. Depression, 5. Suicidality
Intervention(s)
Sites, stratified by regional location, are randomly assigned to the intervention or control arm of the study. Intervention and control sites are then matched based on sample size.

Intervention arm: Participants in the intervention arm receive 8-hours of paediatric mental health training delivered in 1 to 5 sessions over a maximum of 5 weeks according to site preferences. Training consists of three modules delivered in the following order:
1. Common Skills (i.e. communication and counseling skills for eliciting mental health concerns and managing mental health conversation with families)
2. Evidence-based Guidelines (to do with assessing, diagnosing, and managing ADHD, behavioral disorders, anxiety, depression and suicidality)
3. Common elements (brief, broad-based therapeutic techniques for addressing symptom clusters related to attention and behavioral issues, and anxiety and depressive symptoms)
Program delivery includes case-based discussions, as well as twelve short and three long videos demonstrating implementation of the common skills and common elements, respectively, to situate learning. Family-centered and developmental

Wait-list control arm: Participants are asked what they hope to get out of the educational program but are not provided with any aspect of the intervention until all of the final, one-month follow-up measures were collected from all sites.

The families do not receive any intervention. They only participate in the evaluation by filling out questionnaires before their medical appointment with a practitioner at a participating site and 4 months later. Follow-up involves a 15-minute standardized patient skills assessment at one-month follow-up and a semi-structured interview to assess satisfaction with the program conducted 2 to 4 months post follow-up.
Primary Outcome(s)
Practitioners:
Skill enhancement as assessed using:
1. A confidence scale developed by Garcia-Ortega et al at baseline (one week pre-intervention) and one week post-intervention
2. The Physician Confidence Scale at baseline and one week post-intervention
3. The Provider Confidence Scale at baseline and one week post-intervention
4. Standardized Patient Interviews coded using the Roter Interactional Analysis Scale (RIAS) at baseline, one week post-intervention and one month post-intervention
5. Standardized Patient Interviews coded using the trained-skills checklist at baseline and one week post-intervention and one month post-intervention
6. Case-scenarios one week post-intervention

Children/youth and their parents:
Mental health functioning as measured by the Strengths and Difficulties Questionnaire (SDQ) and the General Health Questionnaire (GHQ) at baseline and 4 months.
Secondary Outcome(s)
Practitioners:
1. Knowledge is measured using a 45-item knowledge questionnaire designed for this study at baseline and one week post-intervention
2. Attitudes to mental health care provision are measured using the Physician Belief Scale at baseline and one week post-intervention
3. Ease of access to or consult with specialists is measured using the Ease of Consultation Scale at baseline and one week post-intervention
4. Comfort with referrals is measured using the Referral Comfort Scale (RCS) and the Identification of child mental health problems at baseline and one week post-intervention

Children/youth and their parents:
1. Satisfaction with the visit as rated by youth at baseline and at 4 months
2. Practitioner discussion of mental health topics as rated by parents at baseline and 4 months
Secondary ID(s)
N/A
Source(s) of Monetary Support
The Children's Health Foundation
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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