Clinical trial NCT02174952: Self-help in Adjunct to Pharmacotherapy
Official title: Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Parenting interventions
ADHD
Family functioning
Parent Training
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Institute of Mental Health Nottingham
name: National Institute for Health Research, United Kingdom
First posted: 2014-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC)
timeFrame: Post- Intervention (12 weeks)
Secondary outcomes:
measure: Child ADHD Symptoms
timeFrame: 12 weeks
measure: Family Strain Index (Riley et al, 2006).
timeFrame: 12 weeks
measure: Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
timeFrame: 12 weeks
measure: Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
timeFrame: 12 weeks
measure: Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
timeFrame: 12 weeks
measure: Child Health and Illness Profile (parent and child report; Riley et al, 2004)
timeFrame: 12 weeks
measure: Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003)
timeFrame: 12 weeks
measure: General Health Questionnaire (12 item; Goldberg, 1992)
timeFrame: 12 weeks
measure: Child ADHD symptoms
timeFrame: 28 weeks
measure: Family Strain Index (Riley et al, 2006)
timeFrame: 28 weeks
measure: Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
timeFrame: 28 weeks
measure: Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
timeFrame: 28 weeks
measure: Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
timeFrame: 28 weeks
measure: Child Health and Illness Profile (parent and child report; Riley et al, 2004)
timeFrame: 28 weeks
measure: General Health Questionnaire (12 item; Goldberg, 1992)
timeFrame: 28 weeks
Other outcomes:
measure: Treatment Fidelity
timeFrame: Fortnightly throughout intervention period
measure: Usual Treatment
timeFrame: Baseline, Post-intervention (12 weeks) follow-up (28 weeks)
Locations:
Study officials:
References:
citation: 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.