SchizophreniaNCT02199704
Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series
A study testing Self Directed Positive Parenting Program in people with Schizophrenia and Spectrum, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The aim of the case series study is to explore if a self directed version of the Positive Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with psychosis who are parents. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Spectrum, Disorders
- What is being tested?
- Self Directed Positive Parenting Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Nov 2014
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Parents/caregivers (mothers or fathers) with a Schizophrenia-spectrum diagnosis who are:
- 2. Aged 18 years or more
- 3. Have at least one child aged 3-10 years old
- 4. Have a least 10 hours contact time per week with the child.
- 5. Identify difficulties in parenting during assessment
Who cannot join
- 1. Parents/caregivers and family members who do not have good working knowledge of English. They should have enough practical experience to be able to adequately use the English language to understand and respond to questions, to read and complete questionnaires
- 2. Families who do not have at least one adult who has basic literacy skills
- 3. Families where there is known intention for their children to be taken into care or where the parent(s) have no regular contact with the index child
- 4. Parents with a clinical schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care for their condition and have less than four weeks of stabilisation of psychotic experiences (operationally defined as no significant change to management or severity of symptoms in a four-week period since discharge as assessed from case notes). This is because if a potential parent with schizophrenia had recently required an inpatient stay, it is important to give them sufficient time to readjust to living in the community and ensure sufficient time is provided for symptom stabilisation before taking part
- 5. Families seeking support from services regarding child management issues
- 6. Families actively involved in another current cognitive behavioural therapy based intervention
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the case series study is to explore if a self directed version of the Positive Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with psychosis who are parents.
Read the detailed description
As above.
- Conditions
- Schizophrenia, Spectrum, Disorders
- Being tested
- Self Directed Positive Parenting Program
- Keywords
- Parenting, Psychosis, Schizophrenia, Delusions, Hallucinations
- Medical subject headings
- Schizophrenia, Disease, Psychotic Disorders, Delusions, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Directed Positive Parenting ProgramOther
Also called "Every Parent's Self Help Workbook"
Individuals with psychosis who are parents will receive a copy of the "Every Parent's Self Help Workbook" (Markie-Dadds, Sanders \& Turner, 1999) and up to ten sessions of support. This is a case series study.
| Study group | Role | What they receive |
|---|---|---|
| No control or comparison arm. | Other | This case series study has no control or comparison arm. There is only one arm being evaluated (the self directed parenting intervention). Receives: Other: Self Directed Positive Parenting Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Psychotic Symptom Rating Scales (PSYRATS)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.
Parenting and Family Adjustment Scale (PAFAS)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks.
Secondary outcomes (5)
Eyberg Child Behaviour Inventory (ECBI)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Parenting Task Checklist (PTC)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Depression Anxiety and Stress Scale (DASS-21)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Work and Social Adjustment Scale (WSAS)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Ax from 0 - 16 weeks.
Measured: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Lancashire Care NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Chris Taylor, University of Manchester
- Investigators
- Prof Rachel Calam, PhD, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199704
- Sponsor's protocol ID
- 14/NW/0126
- Status last verified
- Nov 2015
- First submitted
- 22 Jul 2014
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series
- ClinicalTrials.gov ID
- NCT02199704
- Acronym / sponsor ID
- 14/NW/0126
- Conditions
- Schizophrenia, Spectrum, Disorders
- Keywords
- Parenting, Psychosis, Schizophrenia, Delusions, Hallucinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Lancashire Care NHS Foundation Trust
- Study start
- Jun 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Jul 2014 (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 aim of the case series study is to explore if a self directed version of the Positive Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with psychosis who are parents.
Detailed description
As above.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No control or comparison arm. | Other | Other: Self Directed Positive Parenting ProgramThis case series study has no control or comparison arm. There is only one arm being evaluated (the self directed parenting intervention). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Parents/caregivers (mothers or fathers) with a Schizophrenia-spectrum diagnosis who are:
- 2. Aged 18 years or more
- 3. Have at least one child aged 3-10 years old
- 4. Have a least 10 hours contact time per week with the child.
- 5. Identify difficulties in parenting during assessment
Key exclusion criteria (6 listed)
- 1. Parents/caregivers and family members who do not have good working knowledge of English. They should have enough practical experience to be able to adequately use the English language to understand and respond to questions, to read and complete questionnaires
- 2. Families who do not have at least one adult who has basic literacy skills
- 3. Families where there is known intention for their children to be taken into care or where the parent(s) have no regular contact with the index child
- 4. Parents with a clinical schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care for their condition and have less than four weeks of stabilisation of psychotic experiences (operationally defined as no significant change to management or severity of symptoms in a four-week period since discharge as assessed from case notes). This is because if a potential parent with schizophrenia had recently required an inpatient stay, it is important to give them sufficient time to readjust to living in the community and ensure sufficient time is provided for symptom stabilisation before taking part
- 5. Families seeking support from services regarding child management issues
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 |
|---|---|---|
| Self Directed Positive Parenting ProgramAlso: "Every Parent's Self Help Workbook"Individuals with psychosis who are parents will receive a copy of the "Every Parent's Self Help Workbook" (Markie-Dadds, Sanders \& Turner, 1999) and up to ten sessions of support. This is a case series study. | Other | No control or comparison arm. |
Primary outcome
The Psychotic Symptom Rating Scales (PSYRATS)
Time frame: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.
Ax from 0 - 16 weeks.
Parenting and Family Adjustment Scale (PAFAS)
Time frame: Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks.
Ax from 0 - 16 weeks.
5 secondary outcomes
Eyberg Child Behaviour Inventory (ECBI)
Time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Parenting Task Checklist (PTC)
Time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Depression Anxiety and Stress Scale (DASS-21)
Time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Work and Social Adjustment Scale (WSAS)
Time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
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 2 Aug 2016.
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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.
Prof Rachel Calam, PhD study chair
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Directed Positive Parenting Program in people with Schizophrenia and Spectrum, run by University of Manchester at 1 site in United Kingdom.
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 5 inclusion and 6 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 2 Aug 2016. 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 United Kingdom. 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?
The Psychotic Symptom Rating Scales (PSYRATS) (time frame: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.). The study lists 2 primary outcomes in all. 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 2 Aug 2016; AzTrials last refreshed its copy on 29 Oct 2026.