Evaluation of a Parenting and Stress Management Programmme (HAPPY)

• ClinicalTrials.gov Identifier: NCT01777724
• Recruitment Status: Terminated
• First Posted: January 29, 2013
• Last Update Posted: July 18, 2014
• Sponsor: Medical Research Council
• Collaborator: NHS Greater Glasgow and Clyde
• Information provided by (Responsible Party): Dr Marion Henderson, Medical Research Council

Tracking Information

• First Submitted Date: December 14, 2012
• First Posted Date: January 29, 2013
• Last Update Posted Date: July 18, 2014
• Study Start Date: January 2013
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 28, 2013)

• 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) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 19, 2013)

• 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) ]

Original Secondary Outcome Measures (submitted: January 28, 2013)

• 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) ]
  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 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) ]

Current Other Pre-specified Outcome Measures (submitted: January 28, 2013)

• 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 ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Evaluation of a Parenting and Stress Management Programmme
• Official Title: Evaluation of a Parenting and Stress Management Programme: An Exploratory Randomised Controlled Trial of Triple P-Positive Parenting Program and Stress Control
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Parenting
• Parent Mental Health
• Child Behaviour Problems

Intervention

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).

Study Arms

• 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.

• Publications *: 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. Erratum In: BMC Public Health. 2015;15:256.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 16, 2014): 14
• Original Estimated Enrollment (submitted: January 28, 2013): 80
• Actual Study Completion Date: February 2014
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01777724
• Other Study ID Numbers: 5TK90 HAPPY; U1111-1137-1053 ( Other Identifier: World Health Organisation Universal Trial Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr Marion Henderson, Medical Research Council
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical Research Council
• Original Study Sponsor: Same as current
• Collaborators: NHS Greater Glasgow and Clyde

Investigators

• Principal Investigator: Marion Henderson, PhD; Medical Research Council Social and Public Health Sciences Unit

• PRS Account: Medical Research Council
• Verification Date: July 2014