- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01777724
Evaluation of a Parenting and Stress Management Programmme (HAPPY)
July 16, 2014 updated by: Dr Marion Henderson, Medical Research Council
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glasgow, United Kingdom, G12 8RZ
- Medical Research Council Social and Public Health Sciences Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Child has a diagnosis of a developmental or intellectual disability or other significant health impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
The intervention is a combination of Triple P Discussion Groups and Stress Control
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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).
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No Intervention: Control
Waitlist control.
Participants allocated to the waitlist control will be able to access the intervention after post-intervention equivalent measures have been completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Measures dysfunctional parenting practices: laxness, overreactivity, and verbosity
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Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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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)
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Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Measures parents' perceptions of their child's disruptive behaviour
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Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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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)
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Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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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)
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Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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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)
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Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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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)
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Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Family demographics
Time Frame: Baseline
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Demographic information of the participating families
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Baseline
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Parents' satisfaction with the Triple P Discussion Groups and Stress Control, as measured by the Consumer Satisfaction Questionnaire developed for Triple P programmes, and the Consumer Satisfaction Questionnaire developed for Stress Control
Time Frame: Post-intervention (approximately 12 weeks after baseline)
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Post-intervention (approximately 12 weeks after baseline)
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The fidelity of the intervention as measured by the Triple P Discussion Group session content checklists, and session content checklists for Stress Control that were developed for this study
Time Frame: The practitioner/s delivering the intervention will complete a session content checklist after each Triple P Discussion Group and after each Stress Control session
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The practitioner/s delivering the intervention will complete a session content checklist after each Triple P Discussion Group and after each Stress Control session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marion Henderson, PhD, Medical Research Council Social and Public Health Sciences Unit
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
December 14, 2012
First Submitted That Met QC Criteria
January 28, 2013
First Posted (Estimate)
January 29, 2013
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 16, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5TK90 HAPPY
- U1111-1137-1053 (Other Identifier: World Health Organisation Universal Trial Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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