Self-help in Adjunct to Pharmacotherapy

NCT02174952 | Unknown

• 1 other identifier: 12031
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Parenting interventions; ADHD; Family functioning; Parent Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Child ADHD Symptoms

  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

Other Outcomes (2)

• Treatment Fidelity

  Fortnightly throughout intervention period

• Usual Treatment

  Baseline, Post-intervention (12 weeks) follow-up (28 weeks)

Study Arms (2)

TAU+SH

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.

Behavioral: Self-help version of the New Forest Parenting Programme

TAU

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.

Interventions

Self-help version of the New Forest Parenting Programme BEHAVIORAL

TAU+SH

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• Institute of Mental Health Nottingham: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (1)

• Daley D, Tarver J, Sayal K. Efficacy of a self-help parenting intervention for parents of children with attention deficit hyperactivity disorder in adjunct to usual treatment-Small-scale randomized controlled trial. Child Care Health Dev. 2021 Mar;47(2):269-280. doi: 10.1111/cch.12825. Epub 2020 Dec 2.

  PMID: 33159336 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: June 26, 2014
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06