Attention Deficit Hyperactivity Disorder (ADHD)SHIPNCT02174952
Self-help in Adjunct to Pharmacotherapy
A study testing Self-help version of the New Forest Parenting Programme in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of Nottingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Self-help version of the New Forest Parenting Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy
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.
- Being tested
- Self-help version of the New Forest Parenting Programme
- Keywords
- Parenting interventions, ADHD, Family functioning, Parent Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help version of the New Forest Parenting ProgrammeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| TAU+SH | Experimental | 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. Receives: Behavioral: Self-help version of the New Forest Parenting Programme |
| TAU | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post- Intervention (12 weeks)
Secondary outcomes (15)
Child ADHD Symptoms
Parent and teacher report according to SNAP-IV
Measured: 12 weeks
Family Strain Index (Riley et al, 2006).
Measured: 12 weeks
Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
Measured: 12 weeks
Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
Measured: 12 weeks
Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
Measured: 12 weeks
Child Health and Illness Profile (parent and child report; Riley et al, 2004)
Measured: 12 weeks
Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003)
Measured: 12 weeks
General Health Questionnaire (12 item; Goldberg, 1992)
Measured: 12 weeks
Child ADHD symptoms
Parent and teacher report according to SNAP-IV
Measured: 28 weeks
Family Strain Index (Riley et al, 2006)
Measured: 28 weeks
Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
Measured: 28 weeks
Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
Measured: 28 weeks
Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
Measured: 28 weeks
Child Health and Illness Profile (parent and child report; Riley et al, 2004)
Measured: 28 weeks
General Health Questionnaire (12 item; Goldberg, 1992)
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Mental Health Nottingham, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174952
- Sponsor's protocol ID
- 12031
- Acronym
- SHIP
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Self-help Parenting Intervention for Parents of Children With ADHD in Adjunct to Pharmacotherapy
- ClinicalTrials.gov ID
- NCT02174952
- Acronym / sponsor ID
- SHIP / 12031
- Keywords
- Parenting interventions, ADHD, Family functioning, Parent Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Institute of Mental Health Nottingham, National Institute for Health Research, United Kingdom
- Study start
- Jul 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU+SH | Experimental | Behavioral: Self-help version of the New Forest Parenting ProgrammeFamilies 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. |
| TAU | No 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help version of the New Forest Parenting Programme | Behavioural | TAU+SH |
Primary outcome
Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC)
Time frame: 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.
15 secondary outcomes
Child ADHD Symptoms
Time frame: 12 weeks
Family Strain Index (Riley et al, 2006).
Time frame: 12 weeks
Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
Time frame: 12 weeks
Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
Time frame: 12 weeks
Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
Time frame: 12 weeks
Child Health and Illness Profile (parent and child report; Riley et al, 2004)
Time frame: 12 weeks
Parental Expressed emotion via recorded Five Minute Speech Sample (Daley et al, 2003)
Time frame: 12 weeks
General Health Questionnaire (12 item; Goldberg, 1992)
Time frame: 12 weeks
Child ADHD symptoms
Time frame: 28 weeks
Family Strain Index (Riley et al, 2006)
Time frame: 28 weeks
Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1980)
Time frame: 28 weeks
Vanderbilt Diagnostic Rating Scale (Performance scale; Wolraich et al, 2003)
Time frame: 28 weeks
Southampton ADHD medication behaviour and and Attitudes scale (SAMBA)
Time frame: 28 weeks
Child Health and Illness Profile (parent and child report; Riley et al, 2004)
Time frame: 28 weeks
General Health Questionnaire (12 item; Goldberg, 1992)
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Derived from this study: PubMed 33159336Daley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help version of the New Forest Parenting Programme in people with Attention Deficit Hyperactivity Disorder (ADHD), run by University of Nottingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy subscale of the Parenting Sense of Competence Questionnaire (PSOC) (time frame: Post- Intervention (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02174952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.