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
- Are there results?
- None posted in the registry
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.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Parenting Discussion Group in Panama, Central America
- ClinicalTrials.gov ID
- NCT01771068
- Acronym / sponsor ID
- PTY12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Secretariat of Science, Technology and Innovation in Panama (SENACYT)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waiting list | No intervention | – |
| Parenting Discussion Group | Experimental | Behavioral: Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- no report of difficulty in dealing with child behaviour
- illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience" | Behavioural | Parenting Discussion Group |
Primary outcome
Change in Eyberg Child Behaviour Inventory (ECBI)
Time frame: baseline, 2 weeks post intervention, 3 months and 6 months
3 secondary outcomes
Change in Depression Anxiety Stress Scale 21 (DASS 21)
Time frame: baseline, 2 weeks post intervention, 3 months and 6 months
Change in Parenting Scale (PS)
Time frame: baseline, 2 weeks post intervention, 3 months and 6 months
Change in Parenting Task Checklist (PTC)
Time frame: baseline, 2 weeks post intervention, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anilena Mejia, MSc principal investigator
The University of Manchester
Rachel Calam, Professor principal investigator
The University of Manchester
Matthew Sanders, Professor principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eyberg Child Behaviour Inventory (ECBI) (time frame: baseline, 2 weeks post intervention, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.