Self-help in Adjunct to Pharmacotherapy (SHIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Institute of Mental Health Nottingham
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT02174952
First received: June 23, 2014
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD)
Behavioral: Self-help version of the New Forest Parenting Programme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC) [ Time Frame: Post- Intervention (12 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Parent and teacher report according to SNAP-IV

  • Family Strain Index (Riley et al, 2006). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Southampton ADHD medication behaviour and and Attitudes scale (SAMBA) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile (parent and child report; Riley et al, 2004) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • General Health Questionnaire (12 item; Goldberg, 1992) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Child ADHD symptoms [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    Parent and teacher report according to SNAP-IV

  • Family Strain Index (Riley et al, 2006) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Southampton ADHD medication behaviour and and Attitudes scale (SAMBA) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile (parent and child report; Riley et al, 2004) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • General Health Questionnaire (12 item; Goldberg, 1992) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Treatment Fidelity [ Time Frame: Fortnightly throughout intervention period ] [ Designated as safety issue: No ]
    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.

  • Usual Treatment [ Time Frame: Baseline, Post-intervention (12 weeks) follow-up (28 weeks) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02174952     History of Changes
Other Study ID Numbers: 12031
Study First Received: June 23, 2014
Last Updated: June 24, 2014
Health Authority: United Kingdom: NHS Research Ethics Committee

Keywords provided by University of Nottingham:
Parenting interventions
ADHD
Family functioning
Parent Training

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014