Introduction
Criteria (section) | Measurement: criteria parameters | Results | Continuation to a full trial yes/no/recommendations |
---|---|---|---|
Recruitment to cohort rates | # recruited in 2 years: % recruited /sample size estimation | 144 recruited in 1 year | Yes |
Recruitment to treatment rates | % of eligible participants recruiting to the cohort accepting an offer: At least 30% | 23/41 (56%) hom; 27/42 (64%) NT | Yes |
Treatment effects (SMD baseline-6 months) | SMD CGI: mean = < .3 in those implementing a therapy | 36 hom; .55 NT | Yes |
Treatment effects (clinical significance) | CGI T score: 5 percentiles | Use of T scores not feasible due to ceiling effects. SMD (above) used instead | |
Attrition. Cohort | # CQ’s returned at 6 months: at least 30% | 70% (88/124) 6-month questionnaires returned | Yes |
Attrition. Consultations | # consultations attended: 70% of participants accepting intervention attend at least 3 consultations | 39/42 NT; 33/41 homaccepted the offer. | No |
18/39 (46%) NT; 17/33 (52%) hom had 3+ consults. | |||
Acceptability of TQ | #TQs completed at baseline and 6 months: # of reminders needed; # email/telephone/paper responses. Adjustment of measure, collection method, and trial parameters | 54 (43.5%) completed at baseline. 46 (37.1%) completed at 6 months. | Current methods not feasible: more reminders by a variety of methods needed |
Acceptability of CQ | # reminders needed: adjustment of measure, collection method, and trial parameters | Maximum reminders: 3 emails, 1 text, 1 letter. | £10 Boots vouchers introduced improved return rate |
Adverse events | Clinician records: no intervention-related severe adverse events, as defined by CTCAE (2010) and EC (2011) guidelines. | No severe events | Yes |
Appropriate outcome measurement–CQ | # missing items: adjustment of measure. | 5 items missing from paper questionnaires | Continue using on-line questionnaires |
Recruitment of therapists | # recruited fulfilling criteria: at least 2 for each therapy | 8 therapists (hom); 4 therapists (NT) | One (hom) dropped out/unsuitable. Two (hom) using a receptionist and one (NT) only using email made poor contact with participants. |
Suitability of consultation venues/mode | ANCOVA (venue/mode as variable): No venue/mode to have statistically significant impact on treatment effect | This could not be calculated as some therapists used several modes. | |
Statistical analysis | ANCOVA: meets assumptions | Outliers not improved with transformation | Regression analysis used. Assumptions met. |
Methods
Recruitment of the STAR cohort
Collection of outcomes
The pilot RCT
Statistical analysis
Results
Recruitment and participation in the STAR cohort
Questionnaire return
The pilot RCT
Hom offered | Hom received | NT offered | NT received | TAU | All | |
---|---|---|---|---|---|---|
Sample size (i.e. questionnaire return) | ||||||
Baseline | N = 41 | N = 23 | N = 42 | N = 27 | N = 41 | N = 124 |
6 months | N = 29 | N = 20 | N = 28 | N = 23 | N = 31 | N = 88 |
12 months | N = 22 | N = 16 | N = 19 | N = 16 | N = 17 | N = 58 |
Mean (standard deviation) | ||||||
Age | 10.17 (2.42) | 9.78 (2.22) | 10.05 (2.46) | 10.22 (2.68) | 10.41 (2.49) | 10.21 (2.44) |
Female | 8 (19.5%) | 5 (21.7%) | 7 (16.6%) | 4 (14.8%) | 5 (12.2%) | 20 (16.1%) |
Taking pharmaceutical medication | 28 (68%) | 13 (56.5%) | 29 (69%) | 20 (74%) | 27 (65.9%) | 84 (67.7%) |
Have autism | 13 (10%) | 6 (5%) | 9 (7%) | 6 (5%) | 15 (12%) | 37 (30% |
CGI baseline | 23.9 (3.56) | 23.48 (3.27) | 23.9 (3.56) | 23.4 (3.87) | 22.27 (4.62) | 23.1 (4.17) |
CGI 6 months | 20.0 (6.15) | 19.65 (5.83) | 18.82 (5.59) | 18.48 (5.27) | 20.06 (5.29) | 19.65 (5.64) |
CGI 12 months | 19.91 (6.05) | 19.63 (5.8) | 19.84 (5.5) | 19.63 (5.6) | 17.88 (6.7) | 19.27 (6.03) |
Restless/impulsive baseline | 17.61 (2.63) | 17.3 (2.55) | 17.4 (3.09) | 17.67 (3) | 16.98 (3.41) | 17.33 (3.05) |
Restless/impulsive 6 months | 15.28 (4.6) | 14.9 (4.35) | 13.68 (3.89) | 13.39 (3.6) | 15.19 (3.73) | 14.74 (4.1) |
Restless/impulsive 12 months | 15.18 (4.14) | 14.88 (3.56) | 14.42 (4.14) | 14.25 (4.37) | 13.71 (5.24) | 14.5 (4.44) |
Emotional lability baseline | 6.39 (1.56) | 6.17 (1.59) | 5.67 (2.09) | 5.74 (1.99) | 5.29 (1.93) | 5.29 (1.92) |
Emotional lability 6 months | 4.72 (2.15) | 4.75 (2.14) | 5.14 (2.1) | 5.09 (2.09) | 4.87 (2.28) | 4.91 (2.16) |
Emotional lability 12 months | 4.73 (2.43) | 4.75 (2.59) | 5.42 (2.19) | 5.38 (2.13) | 4.18 (2.67) | 4.79 (2.44) |
CHU9D utility scores baseline | .679 (.114) | .676 (.122) | .696 (.106) | .695 (.121) | .708 (.104) | .694 (.108) |
CHU9D utility scores 6 months | .708 (.137) | .684 (.149) | .759 (.121) | .769 (.116) | .708 (.130) | .724 (.130) |
CHU9D utility scores 12 months | .875 (.151) | .837 (.165) | .903 (.138) | .875 (.148) | .885 (.141) | .888 (.143) |
Data analysis of carer ratings
Outcome | Completer | ITT/per protocol |
R
2
| Hom (n = 29 (ITT), n = 20 (received) | NT (n = 28 (ITT), n = 24 received) | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Ba (S.E.) |
t
| C.I. | Effect sizeb | B (S.E.) |
t
| C.I. | Effect sizeb | ||||
CGI | Carer | ITT | .215 | 1.7 (1.57) | 1.08, p = .28 | − 1.48, 4.81 | .425# | 2.66 (1.55) | 1.71, p = .09 | − .347, 5.89 | .388 |
Received | .207 | 1.65 (1.72) | .96, p = .34 | − 1.84, 5.06 | .356 | 3.05 (1.6) | 1.9, p = .062 | − .044, 6.44 | .55# | ||
Teacher | ITT | .290 | .58 (2.89) | .2, p = .84 | − 5.37, 6.53 | .069 | 4.11 (3.14) | 1.31, p = .2 | − 2.35, 10.58 | .39 | |
Received | .176 | .572 (3.16) | .18, p = .86 | − 6.09, 7.24 | .109 | − 1.98 (4.15) | − .477, p = .64 | − 10.74, 6.78 | −.504 | ||
Restless-impulsive | Carer | ITT | .171 | .437 (1.19) | .368, p = .71 | − 1.9, 2.8 | .198 | 2.13 (1.18) | 1.8, p = .075 | − .22, 4.47 | .418# |
Received | .181 | .594 (1.3) | .456, p = .65 | − 2.0, 3.19 | .172 | 2.59 (1.22) | 2.11, p = .038* | .15, 5.03 | .623# | ||
Teacher | ITT | .264 | .176 (2.39) | .074, p = .94 | − 4.75, 5.1 | .016 | 3.5 (2.6) | 1.35, p = .19 | − 1.86, 8.85 | .421# | |
Per protocol | .144 | .456 (2.74) | .166, p = .87 | − 5.33, 6.24 | .097 | − .824 (3.6) | − .229, p = .82 | − 8.42, 6.78 | − .339 | ||
Emotional lability | Carer | ITT | .230 | 1.23 (.59) | 2.09, p = .04* | .06, 2.4 | .793# | .648 (.58) | 1.11, p = .27 | − .51, 1.81 | .269 |
Per protocol | .213 | 1.02 (.64) | 1.59, p = .12 | − .27, 2.3 | .679# | .612 (.6) | 1.01, p = .31 | − .59, 1.82 | .325 | ||
Teacher | ITT | .251 | .403 (.75) | .537, p = .6 | − 1.14, 1.95 | .25 | .615 (.82) | .754, p = .46 | − 1.07, 2.3 | .195 | |
Per protocol | .209 | .117 (.737) | .158, p = .88 | − 1.44, 1.67 | .117 | − 1.16 (.968) | − 1.19, p = .25 | − 3.2, .89 | − .93# | ||
CHU 9D | Carer | ITT | .102 | .057 (.031) | 1.84, p = .069 | − .12, .01 | .43# | .084 (.031) | 2.73, p = .008* | − .15, − .023 | 1.1# |
Per protocol | .122 | .05 (.035) | 1.42, p = .16 | − .12, .02 | .3 | .094 (.03) | 2.84, p = .006* | − .16, − .03 | 1.19# |