Evaluation of the New Forest Parent Training Project with young children in relation to school readiness
| ISRCTN | ISRCTN49487328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49487328 |
| Secondary identifying numbers | KO1 |
- Submission date
- 29/11/2005
- Registration date
- 05/01/2006
- Last edited
- 16/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Margaret Thompson
Scientific
Scientific
School of Medicine
University of Southampton
Southampton
SO17 1BJ
United Kingdom
| Phone | +44 (0)23 8074 3030 |
|---|---|
| mt1@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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 childrens improvement in ADHD and ODD symptoms at the end of experimental treatment. |
| Ethics approval(s) | At a meeting of the Health and Social Services Department's Ethical Committee (16/05/2005) it was agreed to approve the study. |
| Health condition(s) or problem(s) studied | 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 childrens 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 |
| Primary outcome measure | 1. Significant reductions on parent and teacher ratings of childrens ADHD 2. Reductions on oppositional behaviour 3. Improvement in mothers ratings of their parenting satisfaction and efficacy |
| Secondary outcome measures | Children's school readiness. |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | The study will enroll 150 medication naïve children. |
| Key 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. Parents views of the impact of the condition on childrens 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. |
| Key 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). |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Medicine
Southampton
SO17 1BJ
United Kingdom
SO17 1BJ
United Kingdom
Sponsor information
HOPE Wessex Medical Trust (UK)
Charity
Charity
Hope
Allport House
Princes Street
Southampton
SO14 5RP
United Kingdom
| Phone | +44 (0)23 8033 3366 |
|---|---|
| info@hope.org.uk | |
"ROR" |
https://ror.org/0109m8c38 |
Funders
Funder type
Charity
HOPE Wessex Medical Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2009 | Yes | No |
