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Evaluation of a Parenting and Stress Management Programmme (HAPPY)

This study has been terminated.
(The study was terminated due to time constraints and the withdrawal of Stress Control from the NHS Greater Glasgow and Clyde services.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777724
First Posted: January 29, 2013
Last Update Posted: July 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Dr Marion Henderson, Medical Research Council
  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
Intervention Model: Parallel Assignment
Masking: None (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 Dr Marion Henderson, 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) ]
    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) ]

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) ]
    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) ]
  • 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) ]

Other Outcome Measures:
  • Family demographics [ Time Frame: Baseline ]
    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) ]
  • 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 ]

Enrollment: 14
Study Start Date: January 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777724


Locations
United Kingdom
Medical Research Council Social and Public Health Sciences Unit
Glasgow, United Kingdom, G12 8RZ
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:
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 ( Other Identifier: World Health Organisation Universal Trial Number )
First Submitted: December 14, 2012
First Posted: January 29, 2013
Last Update Posted: July 18, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Problem Behavior
Behavioral Symptoms