Evaluation of a Parenting and Stress Management Programmme (HAPPY)

This study is currently recruiting participants.
Verified June 2013 by Medical Research Council
Sponsor:
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: June 19, 2013
Last verified: June 2013
  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 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) ] [ 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 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) ] [ Designated as safety issue: No ]
  • 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) ] [ 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: 160
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 by Medical Research Council

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 19, 2013
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on April 14, 2014