NCT01777724

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

1.1 years

First QC Date

December 14, 2012

Last Update Submit

July 16, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (5)

  • Change in the frequency of disruptive child behaviours as measured by Eyberg Child Behavior Inventory-Intensity scale

    Baseline, post-intervention (approximately 12 weeks after baseline), 3-month follow-up (approximately 24 weeks after baseline)

  • 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)

  • 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)

  • 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)

  • 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)

Other Outcomes (3)

  • Family demographics

    Baseline

  • 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)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention is a combination of Triple P Discussion Groups and Stress Control

Behavioral: Combination of Triple P Discussion Groups and Stress Control

Control

NO INTERVENTION

Waitlist control. Participants allocated to the waitlist control will be able to access the intervention after post-intervention equivalent measures have been completed.

Interventions

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).

Intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Child has a diagnosis of a developmental or intellectual disability or other significant health impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council Social and Public Health Sciences Unit

Glasgow, G12 8RZ, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Marion Henderson, PhD

    Medical Research Council Social and Public Health Sciences Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Investigator Scientist

Study Record Dates

First Submitted

December 14, 2012

First Posted

January 29, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations