scholarly journals A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive–behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents

2013 ◽  
Vol 17 (47) ◽  
Author(s):  
P Stallard ◽  
R Phillips ◽  
AA Montgomery ◽  
M Spears ◽  
R Anderson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
High Risk ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Cluster Randomised Controlled Trial ◽  
Behavioural Therapy ◽  
Symptoms Of Depression ◽  
Cluster Randomised ◽  
Cognitive Behavioural ◽  
Randomised Controlled

scholarly journals A cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of a school-based cognitive–behavioural therapy programme (FRIENDS) in the reduction of anxiety and improvement in mood in children aged 9/10 years

2015 ◽  
Vol 3 (14) ◽  
pp. 1-88 ◽  
Author(s):  
Paul Stallard ◽  
Elena Skryabina ◽  
Gordon Taylor ◽  
Rob Anderson ◽  
Obioha C Ukoumunne ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Schools ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Cluster Randomised Controlled Trial ◽  
Behavioural Therapy ◽  
Anxiety Prevention ◽  
Cognitive Behavioural ◽  
Prevention Programmes ◽  
Randomised Controlled

BackgroundAnxiety in children is common, impairs everyday functioning and increases the risk of severe mental health disorders in adulthood, yet few children with anxiety are identified and referred for treatment.ObjectiveTo investigate the clinical effectiveness and cost-effectiveness of a universal school-based preventative programme (FRIENDS) in reducing symptoms of anxiety and low mood.DesignCluster randomised controlled trial. Schools (n = 41) were randomly assigned after recruitment on a 1 : 1 : 1 basis to health-led FRIENDS, school-led FRIENDS and usual school provision.SettingPrimary schools in three local education authorities in the south-west of England.ParticipantsChildren (n = 1362) aged 9–10 years attending school and participating in personal, social and health education (PSHE).InterventionsThe FRIENDS programme is a cognitive–behavioural therapy programme that develops skills to counter the cognitive, emotional and behavioural aspects of anxiety. The FRIENDS programme was led by either a trained member of the school or a health leader external to the school and was delivered over 9 consecutive weeks. The comparison group received usual school PSHE lessons. Interventions were delivered in the academic year September 2011–July 2012.Main outcome measuresClinical effectiveness assessed by child report of symptoms of anxiety (Revised Child Anxiety and Depression Scale, RCADS); cost-effectiveness based on RCADS and quality-adjusted life-years (Child Health Utility 9 Dimensions, CHU-9D) between baseline and 6 months; process evaluation, evaluation of reach and attrition and qualitative feedback from children, school staff and parents.ResultsAt 12 months there was a difference in the adjusted mean RCADS scores for health-led FRIENDS compared with school-led FRIENDS [–3.91, 95% confidence interval (CI) –6.48 to –1.35] and for health-led FRIENDS compared with usual school provision (–2.66, 95% CI –5.22 to –0.09). At 24 months we were able to assess only 43.6% of our cohort. There were few differences in baseline characteristics between completers and non-completers. Child-reported anxiety in all three groups had reduced by 24 months and there were no longer any group effects. There were no between-group effects for any parent- or child-completed secondary outcomes at 12 or 24 months. The cost of the FRIENDS programme was £52–56 per child. We found no evidence that the FRIENDS programme was cost-effective over a 6-month period; however, our subgroup for the economic analysis differed significantly from our main trial cohort.ConclusionsAlthough greater reductions in anxiety were noted at 12 months when the FRIENDS programme was delivered by health leaders, these additional benefits were not maintained at 24 months. Children’s anxiety levels improved irrespective of the intervention that they received. Our economic evaluation and 24-month assessment had significant shortcomings. However, the universal delivery of specific anxiety prevention programmes will result in additional costs that may be beyond the finances available to most schools. Future work should identify the active ingredients and potential moderators of universal anxiety programmes to determine whether programme length can be reduced, short-term effectiveness maintained and cost-effectiveness improved. At present, our results find limited evidence to support the universal provision of specific anxiety prevention programmes in UK primary schools.Trial registrationCurrent Controlled Trials ISRCTN23563048.FundingThe National Institute for Health Research Public Health Research programme.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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