Table 2.
Secondary outcome definitions
| Outcome | Measurement | Definition |
| Acceptance of index referral | Collected from records | Whether the index referral (ie, the referral made to CAMHS at the point of recruitment to the STADIA trial) was accepted or declined. Acceptance is defined as being offered an appointment within CAMHS, whether or not the initial appointment was attended or subsequent appointments were offered/attended. Collected within 12 months of randomisation. |
| Acceptance of any referral within 12 months of randomisation | Collected from records | Whether the index referral or any subsequent referral to CAMHS (if made) was accepted or not. Acceptance as defined above for index referral. Collected within 12 months of randomisation. |
| Discharge from CAMHS within 12 months | Collected from records | Whether the child/young person was discharged from CAMHS (following acceptance of the index referral) during the 12 months post-randomisation. |
| Re-referral to CAMHS within 12 months | Collected from records | Whether the child/young person was re-referred to CAMHS (for those whose index referral was turned down by CAMHS or those whose index referral was accepted but were subsequently discharged) during the 12 months post-randomisation. |
| Confirmed diagnosis decision | Collected from records | Diagnosis of an emotional disorder or confirmed absence of an emotional disorder coded as ‘yes’ versus uncertainty about the presence of an emotional disorder coded as ‘no’. Diagnosis as defined for primary outcome, collected within 12 months of randomisation. |
| Time from randomisation to diagnosis of emotional disorder | Collected from records | Date of diagnosis will be the first documented eligible diagnosis.Diagnosis as defined for primary outcome, collected within 12 months of randomisation. |
| Diagnoses made over the 12 month period from randomisation | Collected from records | The diagnosis must be documented in the clinical record within 12 months of randomisation by a mental health services clinician in an NHS-delivered or NHS-commissioned service. All diagnoses made within 12 months will be included. Measured using a standard proforma (pre-specified diagnoses). |
| Treatment offered for diagnosed emotional disorder | Collected from records | Whether treatment was offered for a diagnosed emotional disorder, as defined for primary outcome, collected within 12 months of randomisation. |
| Any treatment/interventions given | Collected from records | All treatments/interventions offered by CAMHS for any reason within 12 months of randomisation, whether or not there is a documented diagnosis will be included. |
| Time from randomisation to the decision to offer treatment for a diagnosed emotional disorder | Collected from records | Date of decision will be the first date that the decision to offer treatment for a diagnosed emotional disorder is documented in the clinical notes, collected within 12 months of randomisation. |
| Time from randomisation to start of first treatment for a diagnosed emotional disorder | Collected from records | Date of treatment will be the first date that any treatment offered for a diagnosed emotional disorder is started. Treatment and diagnosed emotional disorder as defined, collected within 12 months of randomisation. |
| Time from randomisation to the decision to offer any treatment | Collected from records | Date of decision will be the first date that the decision to offer any treatment is documented in the clinical notes, collected within 12 months of randomisation. |
| Time from randomisation to start of any treatment | Collected from records | Date of treatment will be the first date that any treatment offered is started. Treatment as defined, collected within 12 months of randomisation. |
| Participant-reported diagnoses received in the 12 months post-randomisation | Participant self-report | Participants will be asked to report whether or not they received a diagnosis of the child/young person’s difficulties from CAMHS in the 12 months post-randomisation and if so, what diagnosis was given and by whom. |
| Depression symptoms in the CYP | Mood and Feelings Questionnaire (MFQ) | MFQ30 is a valid and reliable measure of depression in CYP.31 32 33 items are answered on a 3-point scale (‘not true’=0, ‘somewhat true’=1 point, ‘true’=2 points). Scores range from 0 to 66 with higher scores indicating more severe depressive symptoms. A score of 27 or higher may be indicative of depression. MFQ collected at baseline, 6 and 12 months post-randomisation. |
| Anxiety symptoms in the CYP | Revised CYP’s Anxiety Depression Scale (RCADS) | RCADS33 is a 47-item questionnaire that measures the reported frequency of various symptoms of anxiety and low mood. Each item is rated on a 4-point scale (never=0, sometimes=1, often=2, always=3). An overall anxiety and low mood score is generated, with separate sub-scale scores for separation anxiety, social phobia, generalised anxiety, panic, obsessive–compulsive disorder and major depression. RCADS demonstrates good psychometric properties.34 Total anxiety and depression scores range from 0 to 141. We will record scores for each of the six sub-scales. For analysis metric, we will use the total anxiety score. RCADS collected at baseline, 6 and 12 months post-randomisation. |
| Comorbid oppositional defiant/conduct disorder symptoms in the CYP | Strengths and Difficulties Questionnaire (SDQ) | SDQ35: A 25-item emotional and behavioural screening questionnaire for CYP. Each item is rated on a 3-point scale (not true, somewhat true, certainly true). Values of 0, 1 or 2 are assigned to each response. SDQ comprises five subscales and an impact supplement. The impact supplement asks effect of difficulties on homelife, friendships, education and leisure activities. SDQ has demonstrated reasonable psychometric properties.36–39 Scores on the ‘conduct problems’ subscale will be used in the analysis of this outcome. Subscale scores range from 0 to 10. SDQ collected at baseline, 6 and 12 months post-randomisation. |
| Functional Impairment in the CYP | SDQ | Impact supplement scores will be used to determine functional impairment. Impact scores range from 0 to 10. Collected at baseline, 6 and 12 months postrandomisation. |
| Self-harm thoughts in the CYP | CYP self-report self-harm measure | CYP will be asked to report the frequency of thoughts of self-harm. Frequency of thoughts of self-harm are rated over the last 6 months in the following categories and scored accordingly: Not at all (0) Once or twice Three or more times Collected at baseline, 6 months and 12 months post-randomisation. |
| Self-harm behaviours in the CYP | CYP self-report self-harm measure | CYP will be asked to report frequency of instances of self-harm behaviour. Frequency of self-harm behaviour are rated over the last 6 months in the following categories and scored accordingly: Not at all (0) Once Two or more times Collected at baseline, 6 months and 12 months post-randomisation. |
| Depression symptoms in the parent/carer | Patient Health Questionnaire (PHQ-9) | PHQ-9:40 PHQ-9 is frequently used as a screening tool for depression in general populations. Each of the nine DSM-IV depression criteria are scored as ‘0’ (not at all) to ‘3’ (nearly every day) depending on the frequency with which they were experienced over the last 2 weeks. Total scores range from 0 to 27 with higher scores indicating increased severity of depression, collected at baseline, 6 and 12 months post-randomisation. |
| Anxiety symptoms in the parent/carer | Generalised Anxiety Disorder Assessment (GAD-7) | GAD-7:41 GAD-7 is a measure of the severity of anxiety in general populations. 7 items are rated according to the frequency with which they have been experienced over the past 2 weeks (0 = ‘not at all’, 1 = ‘several days’, 2 = ‘more than half the days’ and 3 = ‘nearly every day’). Total scores range from 0 to 21 with higher scores indicating more severe anxiety. Collected at baseline, 6 and 12 months post-randomisation. |
| Time off education, employment or training because of emotional difficulties for the CYP | Resource use questionnaire | Days missed from education, employment or training (as applicable) for the CYP due to emotional difficulties. Collected at baseline, 6 and 12 months post-randomisation. |
| Health economic outcome measures | ||
| Health-related quality of life in the CYP | Child Health Utility 9D (CHU9D) and EuroQol Quality of Life Questionnaire 5 Domains for Young People (EQ-5D-Y) | CHU9D42 consists of nine individual items with five levels of response per question (scored 1–5), that assess the CYP functioning ‘today’. The following domains are included; worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine and activities. EuroQol-5D youth descriptive system43 comprises five domains; mobility, looking after myself, doing usual activities, having pain or discomfort and feeling worried, sad or unhappy, values of 1, 2 or 3 are assigned to each response. The EuroQol Visual Analogue Scale (EQ-VAS) asks recipients to self-assess their health state ‘today’ from 0 (worst imaginable health) to 100 (best imaginable health), representing individual preferences. These measures will be self-reported by CYP aged 11+, with proxy versions also completed by the parent/carer for CYP <16. Both collected at baseline, 6 and 12 months post-randomisation. |
| Health-related quality of life in the parent/carer | EuroQol Quality of Life Questionnaire 5 Domains, 5 Levels (EQ-5D-5L) | The EuroQol 5-dimension multi attribute utility instrument44 comprises five domains; mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain is scored between 1 and 5. This descriptive profile, in combination with a valuation set, produces a single index for health status representing societal preferences. The index score ranges from −0.59 to 1, with 0 representing death, 1 of-perfect health and <0 of health states worse than death. The EQ-VAS is again included within the EQ-5D instrument Collected at baseline, 6 and 12 months post-randomisation. |
CAMHS, Child and Adolescent Mental Health Services; CYP, children and young people; NHS, National Health Service; STADIA, STAndardised DIagnostic Assessment for children and adolescents with emotional difficulties.