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Self-help in Adjunct to Pharmacotherapy

NCT02174952 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-06-26

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

BEHAVIORAL

Self-help version of the New Forest Parenting Programme

Sponsors & Collaborators

  • Institute of Mental Health Nottingham

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Nottingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174952 on ClinicalTrials.gov