Rethinking ADHD Intervention Trials: Feasibility Testing of Two Treatments (Nutritional Therapy and Homeopathic Treatment)

Rationale
ADHD imposes a burden on children, families and services. Long term evidence for the effectiveness of main and non-mainstream treatments is weak, identifying treatments and generating evidence is expensive, slow, and difficult to compare. This study rethinks ADHD intervention trials and interventions.

Objective
To test the feasibility of the Trials within Cohorts (TWiCs) design and two novel treatments

Methods
An observational cohort of children with ADHD were recruited and outcomes collected at 0, 6 & 12 months from carers and blinded teachers. For the pilot RCT, children were randomised to usual care, the offer of adjunctive homeopathic treatment (hom), or nutritional therapy (NT). After 6 months, the method’s and intervention’s feasibility was assessed.

Results
124/144 cohort participants were eligible for the pilot trial and randomised. 87% offered treatment accepted, 60% took it up. 89 paired carer and 31 paired teacher questionnaires were analysed.

Statistically significant change due to treatments were not observed in carer rated Conners Global ADHD Index total score, but were in emotional lability sub-scores of those offered hom (p= .04, SMD .79); and restless/impulsive sub-scores of those receiving NT (p=.038, SMD = .623). The small number of teacher outcomes were unstable. Both treatments are potentially cost-effective options, with improvements in health-related quality of life (NT (p= .008, SMD = .9); hom (SMD .57, p= .069)).

The design was feasible but requires modification: single requests from teachers were insufficient; carer questionnaires poorly returned until incentivised; crossover from treatment to usual care high; and one homeopath unfeasible.

Conclusion
Identifying and testing interventions to improve outcomes for ADHD presents challenges, but is important. The TwiCs approach, with some modifications, is feasible to efficiently test interventions and compare their acceptability, clinical and cost effectiveness. Two novel interventions pilot tested show preliminary indications of (cost) effectiveness.