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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01777724
Other study ID # 5TK90 HAPPY
Secondary ID U1111-1137-1053
Status Terminated
Phase N/A
First received December 14, 2012
Last updated July 16, 2014
Start date January 2013
Est. completion date February 2014

Study information

Verified date July 2014
Source Medical Research Council
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


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).

Locations

Country Name City State
United Kingdom Medical Research Council Social and Public Health Sciences Unit Glasgow

Sponsors (2)

Lead Sponsor Collaborator
Medical Research Council NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Family demographics Demographic information of the participating families Baseline No
Other 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 Post-intervention (approximately 12 weeks after baseline) No
Other 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 The practitioner/s delivering the intervention will complete a session content checklist after each Triple P Discussion Group and after each Stress Control session No
Primary Change in dysfunctional parenting practices as measured by the Parenting Scale Measures dysfunctional parenting practices: laxness, overreactivity, and verbosity Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
Primary Change in symptoms of depression, anxiety and stress as measured by the Depression Anxiety Stress Scales 21 Baseline, mid-intervention (approximately 4 weeks after baseline), post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
Secondary 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 Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
Secondary Change in positive mental wellbeing as measured by the Short Warwick-Edinburgh Mental Well-being Scale Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
Secondary Change in parents' perceptions of their parenting experiences as measured by the Parenting Experience Survey Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
Secondary Change in parents' perceptions of their parenting self-efficacy as measured by the Child Adjustment and Parent Efficacy Scale-Parent Efficacy subscale Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
Secondary Change in parents' perceptions of their family relationships as measured by the Parenting and Family Adjustment Scale-Family Relationships subscale Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline) No
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