Child Behavioural and Emotional DifficultiesNCT01771068
Trial of a Parenting Discussion Group in Panama, Central America
A study testing Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience" in people with Child Behavioural and Emotional Difficulties and Parenting Practices, run by University of Manchester at 1 site in Panama.
Trial summary
The present study aims to examine the effectiveness of a parenting intervention, the Triple P Positive Parenting Program Level 3 discussion groups "dealing with disobedience". Triple P is a system of interventions to support families and was developed at the University of Queensland in Australia in the 1980's. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavioural and Emotional Difficulties, Parenting Practices
- What is being tested?
- Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePanama
- Study dates
- Apr 2012to Dec 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be Panamanian
- must have at least one child between 3 and 12 years old
- must report some level of difficulty in dealing with their child behaviour.
Who cannot join
- no report of difficulty in dealing with child behaviour
- illiteracy
Trial locations and contacts
1 site in 1 country.
Panama1 site
Ministry of Education, District of Panama
Panama City, Provincia de Panamá
About this study
The present study aims to examine the effectiveness of a parenting intervention, the Triple P Positive Parenting Program Level 3 discussion groups "dealing with disobedience". Triple P is a system of interventions to support families and was developed at the University of Queensland in Australia in the 1980's. As few studies have tested the effectiveness of parenting programs in developing countries, the present study took place in a developing country, Panama.
In a recent study carried out in Australia, this same intervention was found effective in reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam, Milne \& Sanders, 2011).
Read the detailed description
This is a randomized controlled trial (RCT) with two groups (waiting list versus Triple P discussion groups) and measurements at pre-intervention, post intervention, three and six months follow up.
The intervention trialed was a 2-hour, one-session discussion group on child noncompliance. Groups were composed by a maximum of 10 parents and were facilitated by the principal researcher, who is an accredited practitioner. The groups were interactive and discussion based, and a power point presentation with embedded-video clips were used to aid the facilitator. The key points that were covered in the discussion group included reasons for disobedience, parenting traps, encouraging good behaviour, and managing disobedience. Parents also received a workbook that included the content covered in the discussion group and 2 follow up telephone calls to check how they were doing after.
Participants were randomly assigned to a treatment group (Triple P discussion groups) or to a waiting list group. A statistician independent from the research team generated a random list of numbers. Randomization was stratified based on the level of child behavioural difficulties (high or low) measured at baseline. In order to ensure allocation concealment, sequentially-numbered, opaque, sealed envelopes (SNOSE) were opened after participants agreed to take part in the study and completed a baseline assessment. After randomization, those assigned to the waiting list group were assessed at time 1 (baseline) and then 4 weeks, 3 months and 6 months after the first assessment. Those assigned to the treatment group were assessed at time 1 (baseline), 2 weeks, 3 months and 6 months after the intervention. Assessments were carried out by a research assistant who was blind to group allocation.
- Being tested
- Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Waiting list | No intervention | Not described |
| Parenting Discussion Group | Experimental | Two-hour discussion group on child noncompliance. Groups were composed by a maximum of 10 parents and were facilitated by the principal researcher, who is an accredited practitioner. The groups were interactive and discussion based, and a power point presentation with embedded-video clips was used to aid the facilitator. The key points covered in the discussion group included reasons for disobedience, parenting traps, encouraging good behaviour, and managing disobedience. Parents also received a workbook that included the content covered in the discussion group and 2 follow up telephone calls to check how they were doing after the discussion groups. Receives: Behavioral: Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eyberg Child Behaviour Inventory (ECBI)
Measured: baseline, 2 weeks post intervention, 3 months and 6 months
Secondary outcomes (3)
Change in Depression Anxiety Stress Scale 21 (DASS 21)
Measured: baseline, 2 weeks post intervention, 3 months and 6 months
Change in Parenting Scale (PS)
Measured: baseline, 2 weeks post intervention, 3 months and 6 months
Change in Parenting Task Checklist (PTC)
Measured: baseline, 2 weeks post intervention, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavioural and Emotional DifficultiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Secretariat of Science, Technology and Innovation in Panama (SENACYT)
- Responsible party
- Principal investigator, Anilena Mejia, University of Manchester
- Investigators
- Anilena Mejia, MSc, Principal investigator, The University of ManchesterRachel Calam, Professor, Principal investigator, The University of ManchesterMatthew Sanders, Professor, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771068
- Sponsor's protocol ID
- PTY12
- Status last verified
- Jan 2013
- First submitted
- 11 Jan 2013
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes