Evaluation of a Parenting and Stress Management Programmme (HAPPY)
This study is currently recruiting participants.
Verified May 2013 by Medical Research Council
Sponsor:
Medical Research Council
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Dr Marion Henderson, Medical Research Council
ClinicalTrials.gov Identifier:
NCT01777724
First received: December 14, 2012
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parenting Parent Mental Health Child Behaviour Problems |
Behavioral: Combination of Triple P Discussion Groups and Stress Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of a Parenting and Stress Management Programme: An Exploratory Randomised Controlled Trial of Triple P-Positive Parenting Program and Stress Control |
Resource links provided by NLM:
Further study details as provided by Medical Research Council:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in the frequency and number of disruptive child behaviours as measured by Eyberg Child Behavior Inventory [ Time Frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) ] [ Designated as safety issue: No ]Measures parents' perceptions of their child's disruptive behaviour
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Change in parents' perceptions of their task-specific parenting self-efficacy as measured by the Parenting Tasks Checklist [ Time Frame: Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Family demographics [ Time Frame: Baseline ] [ Designated as safety issue: No ]Demographic information of the participating families
- 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) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
The intervention is a combination of Triple P Discussion Groups and Stress Control
|
Behavioral: Combination of Triple P Discussion Groups and Stress Control
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).
|
|
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.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777724
Contacts
| Contact: Dr Marion Henderson, PhD | (+44) 141-357-3949 | marion@sphsu.mrc.ac.uk |
| Contact: Melanie Palmer, BA (Hons) | (+44) 141-357-3949 | mpalmer@sphsu.mrc.ac.uk |
Locations
| United Kingdom | |
| Medical Research Council Social and Public Health Sciences Unit | Recruiting |
| Glasgow, United Kingdom, G12 8RZ | |
| Contact: Marion Henderson, PhD (+44) 141-357-3949 marion@sphsu.mrc.ac.uk | |
| Contact: Melanie Palmer, BA (Hons) (+44) 141-357-3949 mpalmer@sphsu.mrc.ac.uk | |
| Principal Investigator: Marion Henderson, PhD | |
| Sub-Investigator: Melanie Palmer, BA (Hons) | |
Sponsors and Collaborators
Medical Research Council
NHS Greater Glasgow and Clyde
Investigators
| Principal Investigator: | Marion Henderson, PhD | Medical Research Council Social and Public Health Sciences Unit |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Marion Henderson, Senior Investigator Scientist, Medical Research Council |
| ClinicalTrials.gov Identifier: | NCT01777724 History of Changes |
| Other Study ID Numbers: | 5TK90 HAPPY, U1111-1137-1053 |
| Study First Received: | December 14, 2012 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United Kingdom: National Health Service |
ClinicalTrials.gov processed this record on June 17, 2013