CClinicalTrials.gg
Status unknownNCT02174952SHIPUpdated Jun 26, 2014

Self-help in Adjunct to Pharmacotherapy

An interventional study of Self-help version of the New Forest Parenting Programme in Attention Deficit Hyperactivity Disorder (ADHD), sponsored by University of Nottingham. Status unknown. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2014-06-26.

Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
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Study 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.

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Conditions studied

  • Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

  • Parenting interventions
  • ADHD
  • Family functioning
  • Parent Training
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In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    TAU+SH

    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

  • No intervention
    TAU

    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

  • BehavioralSelf-help version of the New Forest Parenting Programme
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What researchers measure

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.

    Time frame: Post- Intervention (12 weeks)

Secondary outcomes

  1. Child ADHD Symptoms

    Parent and teacher report according to SNAP-IV

    Time frame: 12 weeks

  2. Family Strain Index (Riley et al, 2006).

    Time frame: 12 weeks

  3. Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)

    Time frame: 12 weeks

  4. Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)

    Time frame: 12 weeks

  5. Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)

    Time frame: 12 weeks

  6. Child Health and Illness Profile (parent and child report; Riley et al, 2004)

    Time frame: 12 weeks

  7. Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003)

    Time frame: 12 weeks

  8. General Health Questionnaire (12 item; Goldberg, 1992)

    Time frame: 12 weeks

  9. Child ADHD symptoms

    Parent and teacher report according to SNAP-IV

    Time frame: 28 weeks

  10. Family Strain Index (Riley et al, 2006)

    Time frame: 28 weeks

  11. Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)

    Time frame: 28 weeks

  12. Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)

    Time frame: 28 weeks

  13. Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)

    Time frame: 28 weeks

  14. Child Health and Illness Profile (parent and child report; Riley et al, 2004)

    Time frame: 28 weeks

  15. General Health Questionnaire (12 item; Goldberg, 1992)

    Time frame: 28 weeks

Other outcomes

  1. Treatment Fidelity

    Fidelity of self-help intervention will be assessed using a parent self-report rating collected via fortnightly phone calls to parents from research/clinic staff.

    Time frame: Fortnightly throughout intervention period

  2. Usual Treatment

    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.

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33159336 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02174952
Lead sponsor
University of Nottingham
Collaborators
Institute of Mental Health Nottingham, National Institute for Health Research, United Kingdom
Responsible party
Sponsor
First posted
Jun 26, 2014
Start date
Jul 2012
Primary completion
Sep 2014 (estimated)
Completion
Sep 2014 (estimated)
Last update
Jun 26, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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