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Open Access Study protocol

Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD

Donna C McCann1, Margaret Thompson12, David Daley3, Joanne Barton4, Cathy Laver-Bradbury2, Judy Hutchings5, David Coghill6, Louise Stanton7, Tom Maishman7, Liz Dixon7, Josh Caddy7, Maria Chorozoglou8, James Raftery8 and Edmund Sonuga-Barke1*

Author Affiliations

1 Developmental Brain and Behaviour Lab, Psychology, University of Southampton, Southampton SO17 1BJ, UK

2 Child and Adolescent Mental Health Services, Solent NHS Trust, Orchard Centre, Southampton SO16 4XE, UK

3 Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham NG7 2TU, UK

4 North Staffordshire Combined Healthcare NHS Trust, Stoke-on-Trent ST1 5UK, UK

5 School of Psychology and Centre for Evidence Based Early Intervention, Bangor University, Bangor LL57 2PX, UK

6 School of Medicine, University of Dundee, Ninewells Hospital, Dundee DD1 9SY, UK

7 University of Southampton Clinical Trials Unit, Southampton General Hospital, Southampton SO16 6YD, UK

8 Wessex Institute for Health, Research and Development, University of Southampton, Southampton Science Park, Southampton SO16 7NS, UK

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Trials 2014, 15:142  doi:10.1186/1745-6215-15-142

Published: 25 April 2014

Abstract

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/design

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.

Discussion

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.

Trial registration

Current Controlled Trials, ISRCTN39288126.

Keywords:
ADHD; cost-effectiveness; effectiveness; parenting; parenting programme; parent training