Overview

This trial is active, not recruiting.

Condition attention deficit hyperactivity disorder (adhd)
Treatment self-help version of the new forest parenting programme
Sponsor University of Nottingham
Collaborator Institute of Mental Health Nottingham
Start date July 2012
End date September 2014
Trial size 50 participants
Trial identifier NCT02174952, 12031

Summary

Therapist-led parenting interventions have been shown to reduce symptoms of attention deficit hyperactivity disorder (ADHD) and are recommended as a first line treatment for school age children with ADHD. However, parenting interventions can be costly and impractical for parents due to factors such as time constraints and travelling costs. A self-help parent training manual has been developed and initial results have shown moderate reductions in ADHD symptoms, indicating that whilst self-help may offer a cost effective alternative to therapist led parent training interventions, it may not be sufficient to treat ADHD alone. This study therefore aims to compare the efficacy and additional benefits of the self-help intervention plus treatment as usual including pharmacotherapy with a control treatment as usual group . Families with a child aged 6-10 with a clinical diagnosis of ADHD will be recruited to the study via referrals from community paediatricians and child and adolescent mental health services. After gaining informed consent subjects will be randomised to self-help plus Treatment as usual (TAU) + or TAU (control). Those allocated to TAU+SH will be issued with the self-help manual and an introductory DVD to highlight key aspects of the intervention. Self-help intervention will last for 12 weeks. Data will be collected via standardised questionnaires completed by the parent, teacher and child and a recorded speech samples from the parent. Data will be collected at three time points; pre-intervention, post-intervention (12 weeks) and as a long term follow up (28 weeks). After completing the trial, qualitative data will be collected about participants' experience of self-help intervention.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Families allocated to receive their usual treatment + self-help (TAU+SH) will receive 12 weeks of a self-help version of the New Forest Parenting Programme in addition to the usual treatment they are receiving from their clinician. They will also receive an introductory DVD aimed at highlighting key components of the intervention.
self-help version of the new forest parenting programme
(No Intervention)
Families in the Treatment as Usual (TAU) condition will receive nothing additional to the treatment offered by their paediatrician or Child & Adolescent Mental Health Services (CAMHS) during the trial phase. Families in the TAU condition will be offered the self-help manual at the end of the trial.

Primary Outcomes

Measure
Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC)
time frame: Post- Intervention (12 weeks)

Secondary Outcomes

Measure
Child ADHD Symptoms
time frame: 12 weeks
Family Strain Index (Riley et al, 2006).
time frame: 12 weeks
Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
time frame: 12 weeks
Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
time frame: 12 weeks
Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
time frame: 12 weeks
Child Health and Illness Profile (parent and child report; Riley et al, 2004)
time frame: 12 weeks
Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003)
time frame: 12 weeks
General Health Questionnaire (12 item; Goldberg, 1992)
time frame: 12 weeks
Child ADHD symptoms
time frame: 28 weeks
Family Strain Index (Riley et al, 2006)
time frame: 28 weeks
Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
time frame: 28 weeks
Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
time frame: 28 weeks
Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
time frame: 28 weeks
Child Health and Illness Profile (parent and child report; Riley et al, 2004)
time frame: 28 weeks
General Health Questionnaire (12 item; Goldberg, 1992)
time frame: 28 weeks

Eligibility Criteria

Male or female participants from 6 years up to 10 years old.

Inclusion Criteria: - Parent/Main caregiver aged 18 years or over. - Children aged been 6-10 years who have received a clinical diagnosis of ADHD. - Children who are about to commence a course of medication for ADHD for the first time or a currently receiving medication for ADHD. Exclusion Criteria: - Parents who are not fluent in English, or unable to read English. (Due to copyright restrictions the self-help manual is only available in English.) - Families who clinicians feel may be unable/incapable of completing the self-help intervention (e.g. where parents have severe mental illness) - Parents who are aware that they have had previous experience of the NFPP

Additional Information

Official title Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Nottingham.