WHO Clinical Trials Data Set
Background and rationale
Unmet need for child and youth mental health services
Models for integrated mental healthcare for children and youth
Context of the trial
Objectives
Hypothesis
Methods
Trial design
Setting
Participants
Children/youth and their parents
GPs
Recruitment and screening
Children/youth and their parents
Trial follow-up
Randomization and treatment allocation
Masking
Interventions
Intervention arm
Topic | Brief interventions |
---|---|
Patient–provider interaction | Engaging patients in conversation, attentive listening, eliciting an agenda, empathy, giving advice, decision support, interacting with child and parent |
Children with problematic behavior | Assessing possible causes (anxiety, depression, trauma, developmental delay or school problems, attention problems), general parenting advice, help with schoolwork, psychoeducation for families about children with delays, linking to community resources for children with developmental delays, appropriate medication use |
Depression (child and/or parent) | Psychoeducation, behavioral activation, exploration of contributing stresses, exploration of suicidal ideation, safety for suicidal patients, medications for older adolescents and parents |
Anxiety | Psychoeducation, active coping (role models, supported exposure, relaxation), support and response to maladaptive cognitions following trauma, exploration of contributing stresses, indications for medication |
Substance use | Recognition of harmful use of tobacco, alcohol, and inhalants. Brief counseling regarding cessation |
Intellectual disability and learning disorders | Methods of detection, behavioral and pharmacological management of associated behavior and mood problems |
Urgent issues | Thought problems, suicidality, intentional harm to children or risk of harm to others |
Parenting and typical developmental issues | [in addition to behavioral topics above] sleep, toileting [including enuresis and encopresis], masturbation |
Control arm
Support/interventions common to both arms
Fidelity
Outcomes
Outcome | Measure | Timing |
---|---|---|
Primary effectiveness outcome | ||
1. Total child/youth behavioral/emotional problems score | SDQ | Baseline, three, and six months |
Secondary effectiveness outcomes | ||
1. Child/youth function score | SDQ | Baseline, three, and six months |
2. Parent mental health status | GHQ | Baseline, three, and six months |
3. Parent functional status | EuroQol EQ-5D-5 L | Baseline and six months |
4. Satisfaction with GP care | Index visit exit questionnaire | Baseline |
In-depth interviews (sample) | Three and six months | |
5. Use of mental health services | Community services report | Baseline and six months |
TUCCP utilization data | Six months | |
Implementation outcomes | ||
1. GP mental health skill uptake | Standardized patient role plays | Baseline and three months |
2. GP recognition of child/youth mental health problems | GP exit form | Baseline |
GP registration of patient in the TUCCP system | Baseline | |
2. GP treatment or referral for major mental health problem categories | TUCCP operational data | Six months |
3. GP’s confidence in treating mental health problems | Confidence scales | Immediately after training |
4. GP’s attitudes toward mental healthcare | Physician Belief Scale | Immediately after training |
Potential moderating variables | ||
1. Parent and youth demographic characteristics | Self-report of age, gender, education, economic status, ethnicity | Baseline |
2. Parent and youth relationship to GP office | Self-report of number of prior visits, distance from home to office | Baseline |
3. GP characteristics | Training, prior activity in TUCCP, length of time in practice at current location, overall practice volume | Baseline |