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Self-help in Adjunct to Pharmacotherapy (SHIP)

Primary Purpose

Attention Deficit Hyperactivity Disorder (ADHD)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-help version of the New Forest Parenting Programme
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder (ADHD) focused on measuring Parenting interventions, ADHD, Family functioning, Parent Training

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    TAU+SH

    TAU

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 23, 2014
    Last Updated
    June 24, 2014
    Sponsor
    University of Nottingham
    Collaborators
    Institute of Mental Health Nottingham, National Institute for Health Research, United Kingdom
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02174952
    Brief Title
    Self-help in Adjunct to Pharmacotherapy
    Acronym
    SHIP
    Official Title
    Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    September 2014 (Anticipated)
    Study Completion Date
    September 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nottingham
    Collaborators
    Institute of Mental Health Nottingham, National Institute for Health Research, United Kingdom

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorder (ADHD)
    Keywords
    Parenting interventions, ADHD, Family functioning, Parent Training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TAU+SH
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    TAU
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-help version of the New Forest Parenting Programme
    Primary Outcome Measure Information:
    Title
    Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC)
    Description
    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 Outcome Measure Information:
    Title
    Child ADHD Symptoms
    Description
    Parent and teacher report according to SNAP-IV
    Time Frame
    12 weeks
    Title
    Family Strain Index (Riley et al, 2006).
    Time Frame
    12 weeks
    Title
    Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
    Time Frame
    12 weeks
    Title
    Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
    Time Frame
    12 weeks
    Title
    Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
    Time Frame
    12 weeks
    Title
    Child Health and Illness Profile (parent and child report; Riley et al, 2004)
    Time Frame
    12 weeks
    Title
    Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003)
    Time Frame
    12 weeks
    Title
    General Health Questionnaire (12 item; Goldberg, 1992)
    Time Frame
    12 weeks
    Title
    Child ADHD symptoms
    Description
    Parent and teacher report according to SNAP-IV
    Time Frame
    28 weeks
    Title
    Family Strain Index (Riley et al, 2006)
    Time Frame
    28 weeks
    Title
    Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
    Time Frame
    28 weeks
    Title
    Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
    Time Frame
    28 weeks
    Title
    Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
    Time Frame
    28 weeks
    Title
    Child Health and Illness Profile (parent and child report; Riley et al, 2004)
    Time Frame
    28 weeks
    Title
    General Health Questionnaire (12 item; Goldberg, 1992)
    Time Frame
    28 weeks
    Other Pre-specified Outcome Measures:
    Title
    Treatment Fidelity
    Description
    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
    Title
    Usual Treatment
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33159336
    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.
    Results Reference
    derived

    Learn more about this trial

    Self-help in Adjunct to Pharmacotherapy

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