Behavioral SymptomsPhase 3NCT00299442
Self-Help Parent Training for Conduct Problems in Children
A Phase 3 study testing Self-help Triple P Behavioural Family Intervention in people with Behavioral Symptoms, run by University of Oxford at 3 sites in United Kingdom.
Trial summary
This project will introduce a self-help parent training programme for families on National Health Service (NHS) waiting lists for child mental health services. It will examine whether access to treatment can be increased by providing an intervention that requires fewer resources and by releasing clinician time for… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Symptoms
- What is being tested?
- Self-help Triple P Behavioural Family Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jul 2007to Feb 2009
- Phase
- Phase 3
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Families on waiting lists and child and adolescent mental health services clinics with children aged 2-5.
- Scores in the clinical range on a standardised measure of child behaviour problems.
- At least one parent in each family must be literate, fluent English speakers to participate because the self-administered intervention will primarily consist of written instructions and information in English.
Who cannot join
- Clients whose children score below a clinical cut-off score on a standardised measure of child behaviour problems. This is to ensure that participants are appropriate for an intervention aiming to reduce behaviour problems.
- Non-English speakers or those who are unable to read cannot be included because reading English is required to complete the self-administered intervention.
- Children or parents with severe disabilities and children with a developmental disorder (e.g., autism) will be excluded because the version of the parent training programme that will be implemented is not designed for families with these types of problems.
- Children who live with a temporary caregiver will be excluded because the intervention is designed for full-time parents and follow-up will be after one year.
- Children or parents who are currently receiving treatment for psychological problems will be excluded because outcomes may be influenced by interventions not affiliated with this project.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Sue Nicholls Centre
Aylesbury, Bucks, HP20 1EG
Eleanor Rowsell, Ph.D.
Gretchen J Bjornstad, M.Sc.
- Recruiting
Wycombe CAMHS
High Wycombe, Buckinghamshire, HP13 5BW
Susan Wimshurst
Gretchen Bjornstad, M.Sc.
- Recruiting
West Berkshire PCT
Reading, Berkshire, RG1 7TD
Chris Hollingshead
Gretchen J Bjornstad, M.Sc.
About this study
Official title: Can Self-Help Parent Training Reduce Conduct Problems in Children on NHS Waiting Lists for Child Mental Health Services?
This project will introduce a self-help parent training programme for families on National Health Service (NHS) waiting lists for child mental health services. It will examine whether access to treatment can be increased by providing an intervention that requires fewer resources and by releasing clinician time for more serious cases. This intervention will be tested in a randomised, controlled trial in which 35 subjects will receive treatment immediately and 35 will receive treatment after waiting for 10 weeks. All families will also complete questionnaires before and after the 10 week study period in order to measure changes in child behaviour, parenting, and parental mental health. Cost-effectiveness of this programme will also be analysed. Intention-to-treat analyses will be conducted.
- Conditions
- Behavioral Symptoms
- Being tested
- Self-help Triple P Behavioural Family Intervention
- Keywords
- behavior, conduct, child, parenting, self-help, media-based
- Medical subject headings
- Behavioral Symptoms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help Triple P Behavioural Family InterventionBehavioural
Also called Triple P
10-week self-help workbook and videos
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Self-help Triple P Behavioural Family Intervention Receives: Behavioral: Self-help Triple P Behavioural Family Intervention |
| 2 | No intervention | Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyberg Child Behavior Inventory
Measured: 6 months
Sutter-Eyberg Student Behavior Inventory
Measured: 10 weeks
Parent Daily Report
Measured: 6 months
Secondary outcomes (6)
Depression-Anxiety Stress Scale
Measured: 10 weeks
Parent Sense of Competence Scale
Measured: 10 weeks
Parenting Scale
Measured: 10 weeks
Dyadic Adjustment Scale
Measured: 10 weeks
Strengths and Difficulties Questionnaire
Measured: 10 weeks
Therapy Attitude Inventory
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startJul 2007
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (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 Behavioral SymptomsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Investigators
- Paul Montgomery, D. Phil., Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299442
- Sponsor's protocol ID
- 05/Q1606/57
- Other IDs
- ISRCTN12814243
- Status last verified
- Nov 2008
- First submitted
- 3 Mar 2006
- Last updated
- 12 Mar 2009
- Results posted
- No
Publications
Montgomery P, Bjornstad G, Dennis J. Media-based behavioural treatments for behavioural problems in children. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD002206. doi: 10.1002/14651858.CD002206.pub3.
PubMed 16437442
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Self-Help Parent Training Reduce Conduct Problems in Children on NHS Waiting Lists for Child Mental Health Services?
- ClinicalTrials.gov ID
- NCT00299442
- Acronym / sponsor ID
- 05/Q1606/57
- Conditions
- Behavioral Symptoms
- Keywords
- behavior, conduct, child, parenting, self-help, media-based
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 6 Mar 2006 (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.
This project will introduce a self-help parent training programme for families on National Health Service (NHS) waiting lists for child mental health services. It will examine whether access to treatment can be increased by providing an intervention that requires fewer resources and by releasing clinician time for more serious cases. This intervention will be tested in a randomised, controlled trial in which 35 subjects will receive treatment immediately and 35 will receive treatment after waiting for 10 weeks. All families will also complete questionnaires before and after the 10 week study period in order to measure changes in child behaviour, parenting, and parental mental health. Cost-effectiveness of this programme will also be analysed. Intention-to-treat analyses will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Self-help Triple P Behavioural Family InterventionSelf-help Triple P Behavioural Family Intervention |
| 2 | No intervention | –Wait-list control |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Families on waiting lists and child and adolescent mental health services clinics with children aged 2-5.
- Scores in the clinical range on a standardised measure of child behaviour problems.
- At least one parent in each family must be literate, fluent English speakers to participate because the self-administered intervention will primarily consist of written instructions and information in English.
Key exclusion criteria (5 listed)
- Clients whose children score below a clinical cut-off score on a standardised measure of child behaviour problems. This is to ensure that participants are appropriate for an intervention aiming to reduce behaviour problems.
- Non-English speakers or those who are unable to read cannot be included because reading English is required to complete the self-administered intervention.
- Children or parents with severe disabilities and children with a developmental disorder (e.g., autism) will be excluded because the version of the parent training programme that will be implemented is not designed for families with these types of problems.
- Children who live with a temporary caregiver will be excluded because the intervention is designed for full-time parents and follow-up will be after one year.
- Children or parents who are currently receiving treatment for psychological problems will be excluded because outcomes may be influenced by interventions not affiliated with this project.
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 Triple P Behavioural Family InterventionAlso: Triple P10-week self-help workbook and videos | Behavioural | 1 |
Primary outcome
Eyberg Child Behavior Inventory
Time frame: 6 months
Sutter-Eyberg Student Behavior Inventory
Time frame: 10 weeks
Parent Daily Report
Time frame: 6 months
6 secondary outcomes
Depression-Anxiety Stress Scale
Time frame: 10 weeks
Parent Sense of Competence Scale
Time frame: 10 weeks
Parenting Scale
Time frame: 10 weeks
Dyadic Adjustment Scale
Time frame: 10 weeks
Strengths and Difficulties Questionnaire
Time frame: 10 weeks
Therapy Attitude Inventory
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
- Background: PubMed 16437442Montgomery P, Bjornstad G, Dennis J. Media-based behavioural treatments for behavioural problems in children. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD002206. doi: 10.1002/14651858.CD002206.pub3.
Related trials for Behavioral Symptoms
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Using Non-invasive Brain Stimulation to Explore Potential Treatments to Reduce Speech Errors in Adults Who Stutter
Stuttering, Fluency Disorder
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
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.
Paul Montgomery, D. Phil. principal investigator
University of Oxford
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-help Triple P Behavioural Family Intervention in people with Behavioral Symptoms, run by University of Oxford at 3 sites in United Kingdom.
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 5 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 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Gretchen J. Bjornstad, M.Sc. (+44(0)1865 270342, gretchen.bjornstad@socres.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyberg Child Behavior Inventory (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT00299442, 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 12 Mar 2009.