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Clinical Trials/NCT02174952
NCT02174952
Unknown
Not Applicable

Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy

University of Nottingham0 sites50 target enrollmentJuly 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor
University of Nottingham
Enrollment
50
Primary Endpoint
Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC)
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC)

Time Frame: Post- Intervention (12 weeks)

This questionnaire provides a measure of parenting confidence and satisfaction within their parenting role; parents of children with ADHD often report low parenting efficacy.

Secondary Outcomes

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

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