Evaluation of a Parenting and Stress Management Programmme (HAPPY)
Primary Purpose
Parenting, Parent Mental Health, Child Behaviour Problems
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Combination of Triple P Discussion Groups and Stress Control
Sponsored by
About this trial
This is an interventional treatment trial for Parenting
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
Sites / Locations
- Medical Research Council Social and Public Health Sciences Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The intervention is a combination of Triple P Discussion Groups and Stress Control
Waitlist control. Participants allocated to the waitlist control will be able to access the intervention after post-intervention equivalent measures have been completed.
Outcomes
Primary Outcome Measures
Change in dysfunctional parenting practices as measured by the Parenting Scale
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
Secondary Outcome Measures
Change in the frequency of disruptive child behaviours as measured by Eyberg Child Behavior Inventory-Intensity scale
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
Change in parents' perceptions of their parenting experiences as measured by the Parenting Experience Survey
Change in parents' perceptions of their parenting self-efficacy as measured by the Child Adjustment and Parent Efficacy Scale-Parent Efficacy subscale
Change in parents' perceptions of their family relationships as measured by the Parenting and Family Adjustment Scale-Family Relationships subscale
Full Information
NCT ID
NCT01777724
First Posted
December 14, 2012
Last Updated
July 16, 2014
Sponsor
Medical Research Council
Collaborators
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT01777724
Brief Title
Evaluation of a Parenting and Stress Management Programmme
Acronym
HAPPY
Official Title
Evaluation of a Parenting and Stress Management Programme: An Exploratory Randomised Controlled Trial of Triple P-Positive Parenting Program and Stress Control
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to time constraints and the withdrawal of Stress Control from the NHS Greater Glasgow and Clyde services.
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Research Council
Collaborators
NHS Greater Glasgow and Clyde
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Parent Mental Health, Child Behaviour Problems
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention is a combination of Triple P Discussion Groups and Stress Control
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waitlist control. Participants allocated to the waitlist control will be able to access the intervention after post-intervention equivalent measures have been completed.
Intervention Type
Behavioral
Intervention Name(s)
Combination of Triple P Discussion Groups and Stress Control
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in dysfunctional parenting practices as measured by the Parenting Scale
Description
Measures dysfunctional parenting practices: laxness, overreactivity, and verbosity
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)
Title
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 Measure Information:
Title
Change in the frequency of disruptive child behaviours as measured by Eyberg Child Behavior Inventory-Intensity scale
Description
Measures parents' perceptions of their child's disruptive behaviour
Time Frame
Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)
Title
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)
Title
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)
Title
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)
Title
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 Pre-specified Outcome Measures:
Title
Family demographics
Description
Demographic information of the participating families
Time Frame
Baseline
Title
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)
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Henderson, PhD
Organizational Affiliation
Medical Research Council Social and Public Health Sciences Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Council Social and Public Health Sciences Unit
City
Glasgow
ZIP/Postal Code
G12 8RZ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24066966
Citation
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.
Results Reference
derived
Links:
URL
http://www.sphsu.mrc.ac.uk/
Description
Medical Research Council Social and Public Health Sciences Unit homepage
Learn more about this trial
Evaluation of a Parenting and Stress Management Programmme
We'll reach out to this number within 24 hrs