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
  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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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: July 16, 2014
Health Authority: United Kingdom: National Health Service

ClinicalTrials.gov processed this record on July 28, 2014