Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD.
BACKGROUND
The New Forest Parenting Programme (NFPP) is a home-delivered, evidence-based parenting programme to target symptoms of attention-deficit/hyperactivity disorder (ADHD) in preschool children. It has been adapted for use with 'hard-to-reach' or 'difficult-to-treat' children. This trial will compare the adapted-NFPP with a generic parenting group-based programme, Incredible Years (IY), which has been recommended for children with preschool-type ADHD symptoms.


METHODS
This multicentre randomized controlled trial comprises three arms: adapted-NFPP, IY and treatment as usual (TAU). A sample of 329 parents of preschool-aged children with a research diagnosis of ADHD enriched for hard-to-reach and potentially treatment-resistant children will be allocated to the arms in the ratio 3:3:1. Participants in the adapted-NFPP and IY arms receive an induction visit followed by 12 weekly parenting sessions of 1½ hours (adapted-NFPP) or 2½ hours (IY) over 2.5 years. Adapted-NFPP will be delivered as a one-to-one home-based intervention; IY, as a group-based intervention. TAU participants are offered a parenting programme at the end of the study. The primary objective is to test whether the adapted-NFPP produces beneficial effects in terms of core ADHD symptoms. Secondary objectives include examination of the treatment impact on secondary outcomes, a study of cost-effectiveness and examination of the mediating role of treatment-induced changes in parenting behaviour and neuropsychological function. The primary outcome is change in ADHD symptoms, as measured by the parent-completed version of the SNAP-IV questionnaire, adjusted for pretreatment SNAP-IV score. Secondary outcome measures are: a validated index of behaviour during child's solo play; teacher-reported SNAP-IV (ADHD scale); teacher and parent SNAP-IV (ODD) Scale; Eyberg Child Behaviour Inventory - Oppositional Defiant Disorder scale; Revised Client Service Receipt Inventory - Health Economics Costs measure and EuroQol (EQ5D) health-related quality-of-life measure. Follow-up measures will be collected 6 months after treatment for participants allocated to adapted-NFPP and IY.


CONCLUSIONS
This trial will provide evidence as to whether the adapted-NFPP is more effective and cost-effective than the recommended treatment and TAU. It will also provide information about mediating factors (improved parenting and neuropsychological function) and moderating factors (parent and child genetic factors) in any increased benefit.


BACKGROUND
Current Controlled Trials, ISRCTN39288126.
Donna C
DC
McCann
Margaret
M
Thompson
David
D
Daley
Joanne
J
Barton
Cathy
C
Laver-Bradbury
Judy
J
Hutchings
David
D
Coghill
Louise
L
Stanton
Tom
T
Maishman
Liz
L
Dixon
Josh
J
Caddy
Maria
M
Chorozoglou
James
J
Raftery
Developmental Brain and Behaviour Lab, Psychology, University of Southampton, Southampton SO17 1BJ, UK. ejb3@soton.ac.uk.
Edmund
E
Sonuga-Barke
D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D002652:Child Behavior; D002675:Child, Preschool; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004505:Education, Nonprofessional / Q000191:economics / Q000379:methods*; D004739:England; D006126:Group Processes; D017048:Health Care Costs; D006699:Home Care Services / Q000191:economics; D006801:Humans; D010287:Parent-Child Relations; D016487:Parenting / Q000523:psychology*; D010290:Parents / Q000193:education* / Q000523:psychology*; D015397:Program Evaluation; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome