ParentingHAPPYNCT01777724
Evaluation of a Parenting and Stress Management Programmme
A study of Parenting and Parent Mental Health, run by Medical Research Council at 1 site in United Kingdom.
Trial summary
The study will use a randomised controlled trial design to evaluate the effects of a combined intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in comparison to a waitlist condition. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Parent Mental Health, Child Behaviour Problems
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Feb 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Has a child aged between 3 and 8 years old
- Able to attend the group sessions held at Langside Halls, Shawlands in Glasgow, United Kingdom
- Able to read a newspaper without assistance
Who cannot join
- Child has a diagnosis of a developmental or intellectual disability or other significant health impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medical Research Council Social and Public Health Sciences Unit
Glasgow, G12 8RZ
About this study
Official title: Evaluation of a Parenting and Stress Management Programme: An Exploratory Randomised Controlled Trial of Triple P-Positive Parenting Program and Stress Control
The study will use a randomised controlled trial design to evaluate the effects of a combined intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in comparison to a waitlist condition. The combined intervention will be evaluated with parents in Glasgow, United Kingdom, with a 3-8 year old child.
- Conditions
- Parenting, Parent Mental Health, Child Behaviour Problems
- Being tested
- Combination of Triple P Discussion Groups and Stress Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Triple P Discussion Groups and Stress ControlBehavioural
The intervention consists of eight group sessions: two 120 minute Triple P Discussion Group sessions (http://www.triplep.net/), and six 90 minute Stress Control sessions (http://glasgowsteps.com/home.php).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention is a combination of Triple P Discussion Groups and Stress Control Receives: Behavioral: Combination of Triple P Discussion Groups and Stress Control |
| Control | No intervention | Waitlist control. Participants allocated to the waitlist control will be able to access the intervention after post-intervention equivalent measures have been completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dysfunctional parenting practices as measured by the Parenting Scale
Measures dysfunctional parenting practices: laxness, overreactivity, and verbosity
Measured: Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in symptoms of depression, anxiety and stress as measured by the Depression Anxiety Stress Scales 21
Measured: Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Secondary outcomes (5)
Change in the frequency of disruptive child behaviours as measured by Eyberg Child Behavior Inventory-Intensity scale
Measures parents' perceptions of their child's disruptive behaviour
Measured: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in positive mental wellbeing as measured by the Short Warwick-Edinburgh Mental Well-being Scale
Measured: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in parents' perceptions of their parenting experiences as measured by the Parenting Experience Survey
Measured: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in parents' perceptions of their parenting self-efficacy as measured by the Child Adjustment and Parent Efficacy Scale-Parent Efficacy subscale
Measured: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in parents' perceptions of their family relationships as measured by the Parenting and Family Adjustment Scale-Family Relationships subscale
Measured: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: The study was terminated due to time constraints and the withdrawal of Stress Control from the NHS Greater Glasgow and Clyde services.
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 ParentingStudies 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Principal investigator, Dr Marion Henderson, Medical Research Council
- Investigators
- Marion Henderson, PhD, Principal investigator, Medical Research Council Social and Public Health Sciences Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777724
- Sponsor's protocol ID
- 5TK90 HAPPY
- Other IDs
- U1111-1137-1053
- Acronym
- HAPPY
- Status last verified
- Jul 2014
- First submitted
- 14 Dec 2012
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmer ML, Henderson M, Sanders MR, Keown LJ, White J. Study protocol: evaluation of a parenting and stress management programme: a randomised controlled trial of Triple P Discussion Groups and Stress Control. BMC Public Health. 2013 Sep 25;13:888. doi: 10.1186/1471-2458-13-888.
PubMed 24066966
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Parenting and Stress Management Programme: An Exploratory Randomised Controlled Trial of Triple P-Positive Parenting Program and Stress Control
- ClinicalTrials.gov ID
- NCT01777724
- Acronym / sponsor ID
- HAPPY / 5TK90 HAPPY
- Conditions
- Parenting, Parent Mental Health, Child Behaviour Problems
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to time constraints and the withdrawal of Stress Control from the NHS Greater Glasgow and Clyde services.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical Research CouncilOther government
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Jan 2013 (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.
The study will use a randomised controlled trial design to evaluate the effects of a combined intervention of Triple P-Positive Parenting Program Discussion Groups and Stress Control in comparison to a waitlist condition. The combined intervention will be evaluated with parents in Glasgow, United Kingdom, with a 3-8 year old child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Combination of Triple P Discussion Groups and Stress ControlThe intervention is a combination of Triple P Discussion Groups and Stress Control |
| Control | No intervention | –Waitlist control. Participants allocated to the waitlist control will be able to access the intervention after post-intervention equivalent measures have been completed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Has a child aged between 3 and 8 years old
- Able to attend the group sessions held at Langside Halls, Shawlands in Glasgow, United Kingdom
- Able to read a newspaper without assistance
Key exclusion criteria (1 listed)
- Child has a diagnosis of a developmental or intellectual disability or other significant health impairment
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 |
|---|---|---|
| Combination of Triple P Discussion Groups and Stress ControlThe intervention consists of eight group sessions: two 120 minute Triple P Discussion Group sessions (http://www.triplep.net/), and six 90 minute Stress Control sessions (http://glasgowsteps.com/home.php). | Behavioural | Intervention |
Primary outcome
Change in dysfunctional parenting practices as measured by the Parenting Scale
Time frame: Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Measures dysfunctional parenting practices: laxness, overreactivity, and verbosity
Change in symptoms of depression, anxiety and stress as measured by the Depression Anxiety Stress Scales 21
Time frame: Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
5 secondary outcomes
Change in the frequency of disruptive child behaviours as measured by Eyberg Child Behavior Inventory-Intensity scale
Time frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in positive mental wellbeing as measured by the Short Warwick-Edinburgh Mental Well-being Scale
Time frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in parents' perceptions of their parenting experiences as measured by the Parenting Experience Survey
Time frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in parents' perceptions of their parenting self-efficacy as measured by the Child Adjustment and Parent Efficacy Scale-Parent Efficacy subscale
Time frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Change in parents' perceptions of their family relationships as measured by the Parenting and Family Adjustment Scale-Family Relationships subscale
Time frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Results and safety
The study was stopped early (reason given: The study was terminated due to time constraints and the withdrawal of Stress Control from the NHS Greater Glasgow and Clyde services.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- Derived from this study: PubMed 24066966Palmer ML, Henderson M, Sanders MR, Keown LJ, White J. Study protocol: evaluation of a parenting and stress management programme: a randomised controlled trial of Triple P Discussion Groups and Stress Control. BMC Public Health. 2013 Sep 25;13:888. doi: 10.1186/1471-2458-13-888.
- Medical Research Council Social and Public Health Sciences Unit homepageLink provided by the sponsor.
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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.
Marion Henderson, PhD principal investigator
Medical Research Council Social and Public Health Sciences Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Parenting and Parent Mental Health, run by Medical Research Council at 1 site 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 1 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: stopped early, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to time constraints and the withdrawal of Stress Control from the NHS Greater Glasgow and Clyde services.). 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?
Change in dysfunctional parenting practices as measured by the Parenting Scale (time frame: Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)). The study lists 2 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 NCT01777724, 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 18 Jul 2014.