Self-help in Adjunct to Pharmacotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Behavioral: Self-help version of the New Forest Parenting Programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU+SH<br>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. | Behavioral: Self-help version of the New Forest Parenting Programme<br> <br> |
| No Intervention: TAU<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC) | This questionnaire provides a measure of parenting confidence and satisfaction within their parenting role; parents of children with ADHD often report low parenting efficacy. | Post- Intervention (12 weeks) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenting interventions, ADHD, Family functioning, Parent Training