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:
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: July 16, 2014
Last verified: July 2014

December 14, 2012
July 16, 2014
January 2013
February 2014   (final data collection date for 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) ] [ 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 ]
Same as current
Complete list of historical versions of study NCT01777724 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
 
Evaluation of a Parenting and Stress Management Programmme
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Parenting
  • Parent Mental Health
  • Child Behaviour Problems
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).
  • Experimental: Intervention
    The intervention is a combination of Triple P Discussion Groups and Stress Control
    Intervention: Behavioral: Combination of Triple P Discussion Groups and Stress Control
  • 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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01777724
5TK90 HAPPY, U1111-1137-1053
No
Dr Marion Henderson, Medical Research Council
Medical Research Council
NHS Greater Glasgow and Clyde
Principal Investigator: Marion Henderson, PhD Medical Research Council Social and Public Health Sciences Unit
Medical Research Council
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP