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

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

1745-6215
142
McCann, Donna C.
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Thompson, Margaret
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Daley, David
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Barton, Joanne
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Laver-Bradbury, Cathy
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Hutchings, Judy
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Coghill, David
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Stanton, Louise
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Maishman, T.
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Dixon, E.
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Caddy, Josh
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Chorozoglou, Maria
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Raftery, James
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Sonuga-Barke, Edmund
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McCann, Donna C.
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Thompson, Margaret
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Daley, David
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Barton, Joanne
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Laver-Bradbury, Cathy
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Hutchings, Judy
f6b0ba89-db4c-4945-8d67-442e0accd9fc
Coghill, David
deea8957-fdfc-488a-a3bb-fb9b536c7172
Stanton, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Maishman, T.
cf4259a4-0eef-4975-9c9d-a2c3d594f989
Dixon, E.
f2e33dd1-36f5-4a82-8d3b-ebd5b14cb675
Caddy, Josh
c9f48059-2d70-45e4-a80a-978bf74fac34
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Raftery, James
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Sonuga-Barke, Edmund
bc80bf95-6cf9-4c76-a09d-eaaf0b717635

McCann, Donna C., Thompson, Margaret, Daley, David, Barton, Joanne, Laver-Bradbury, Cathy, Hutchings, Judy, Coghill, David, Stanton, Louise, Maishman, T., Dixon, E., Caddy, Josh, Chorozoglou, Maria, Raftery, James and Sonuga-Barke, Edmund (2014) Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD. Trials, 15 (1), 142. (doi:10.1186/1745-6215-15-142).

Record type: Article

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.

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Published date: 25 April 2014
Organisations: Faculty of Medicine, Faculty of Health Sciences, Clinical Neuroscience, Clinical Trials Unit

Identifiers

Local EPrints ID: 364404
URI: https://eprints.soton.ac.uk/id/eprint/364404
ISSN: 1745-6215
PURE UUID: 88dbab3e-e363-45c8-aa5b-f4afefb23d0c
ORCID for Louise Stanton: ORCID iD orcid.org/0000-0001-8181-840X

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Date deposited: 25 Apr 2014 11:11
Last modified: 20 Jul 2019 00:52

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Contributors

Author: Donna C. McCann
Author: David Daley
Author: Joanne Barton
Author: Cathy Laver-Bradbury
Author: Judy Hutchings
Author: David Coghill
Author: Louise Stanton ORCID iD
Author: T. Maishman
Author: E. Dixon
Author: Josh Caddy
Author: James Raftery
Author: Edmund Sonuga-Barke

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