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Self-help in Adjunct to Pharmacotherapy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02174952
Acronym
SHIP
Enrollment
50
Registered
2014-06-26
Start date
2012-07-31
Completion date
2014-09-30
Last updated
2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Parenting interventions, ADHD, Family functioning, Parent Training

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.

Interventions

BEHAVIORALSelf-help version of the New Forest Parenting Programme

Sponsors

Institute of Mental Health Nottingham
CollaboratorOTHER
National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Child ADHD Symptoms12 weeksParent and teacher report according to SNAP-IV
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 ADHD symptoms28 weeksParent and teacher report according to SNAP-IV
Family Strain Index (Riley et al, 2006)28 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

Other

MeasureTime frameDescription
Treatment FidelityFortnightly throughout intervention periodFidelity of self-help intervention will be assessed using a parent self-report rating collected via fortnightly phone calls to parents from research/clinic staff.
Usual TreatmentBaseline, Post-intervention (12 weeks) follow-up (28 weeks)A treatment report form questionnaire will be used to gain information about other treatments being received for ADHD. This information will be requested initially from parents and then, with consent, from clinicians if parents feel unable/fail to provide.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026