Condition category
Mental and Behavioural Disorders
Date applied
29/11/2005
Date assigned
05/01/2006
Last edited
16/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margaret Thompson

ORCID ID

Contact details

School of Medicine
University of Southampton
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8074 3030
mt1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KO1

Study information

Scientific title

Acronym

Study hypothesis

Hypothesis A:
New Forest Parent Training Project (NFPP) will be superior to treatment as usual (TAU) according to parent and teacher ratings of ADHD:
1. At the end of the experimental trial and
2. Over the ensuing 15 weeks
3. In addition, in follow-up (not funded by this grant) NFPP will be associated with delayed initiation of medication treatment and better transition to school

Hypothesis B:
Because NFPP targets oppositional behavior, as well as ADHD, we hypothesize:
1. That NFPP will result in significant reductions in Oppositional Defiant Disorder (ODD) symptoms compared to TAU at the end of the experimental trial
Because of its expected power to reduce ADHD, a known risk for the development of ODD, we hypothesize:
2. That NFPP will be superior to TAU in preventing the onset of ODD symptoms over two years (not funded by this grant)

Hypotheseis C:
NFPP will be associated with significantly more improvement in mothers’ ratings of their parenting satisfaction and efficacy and in all targeted parenting domains compared to TAU immediately after treatment.

Hypothesis D:
Changes in parenting will have positive mediating effects on children’s improvement in ADHD and ODD symptoms at the end of experimental treatment.

Ethics approval

At a meeting of the Health and Social Services Department's Ethical Committee (16/05/2005) it was agreed to approve the study.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Children will be randomized in equal numbers to NFPP and the control condition.
The New Forest Parenting Package is a manualized treatment program for preschoolers with ADHD, which involves 8 weekly one hour sessions, delivered in the home by trained clinicians.
An Assessment and Referral Treatment as Usual (TAU) group is intended to control for the effects of time and to compare NFPP treatment effects with the potential impact of interventions provided by community-based practitioners on children’s and parents’ functioning during the course of treatment and follow-up.
Participants randomized to TAU will be assessed at the same time points and on the same measures as those randomized to NFPP. TAU participants will receive no treatment from study staff, nor will they be referred to specific contact. Rather, they will be given contact information for child mental health and related agencies (e.g. AACAP, APA [Psychology and Pediatrics Associations], CHADD etc.).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Significant reductions on parent and teacher ratings of children’s ADHD
2. Reductions on oppositional behaviour
3. Improvement in mother’s ratings of their parenting satisfaction and efficacy

Secondary outcome measures

Children's school readiness.

Overall trial start date

01/10/2005

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

The study will enroll young children who meet diagnostic criteria for ADHD.
At the first stage, children will be selected on the basis of scores of 20 or more on the Werry-Weiss-Peters-Hyperactivity Scale (WWP; Routh, 1978), which is a short pre-school hyperactivity screening measure. Parent’s views of the impact of the condition on children’s functioning will then be assessed (stage 2). Finally, children will have to score 18 or more on a pre-school version of the Parental Account of Childhood Symptoms (PACS; Taylor et al., 1991) interview.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

The study will enroll 150 medication naïve children.

Participant exclusion criteria

Excluded will be children with pervasive developmental disorder, psychosis, severe receptive language impairment, neurological disorders, or current history of child sexual or physical abuse. Parents will be excluded from the trial only if they are unable to fulfill the requirements for study participation (e.g. allow home visits, fluent in English).

Recruitment start date

01/10/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Medicine
Southampton
SO17 1BJ
United Kingdom

Sponsor information

Organisation

HOPE Wessex Medical Trust (UK)

Sponsor details

Hope
Allport House
Princes Street
Southampton
SO14 5RP
United Kingdom
+44 (0)23 8033 3366
info@hope.org.uk

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

HOPE Wessex Medical Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19404717

Publication citations

  1. Results

    Thompson MJ, Laver-Bradbury C, Ayres M, Le Poidevin E, Mead S, Dodds C, Psychogiou L, Bitsakou P, Daley D, Weeks A, Brotman LM, Abikoff H, Thompson P, Sonuga-Barke EJ, A small-scale randomized controlled trial of the revised new forest parenting programme for preschoolers with attention deficit hyperactivity disorder., Eur Child Adolesc Psychiatry, 2009, 18, 10, 605-616, doi: 10.1007/s00787-009-0020-0.

Additional files

Editorial Notes