ParentingNCT02622048
Understanding and Helping Families: Parents With Psychosis
A study testing Triple P Positive Parenting Programme in people with Parenting and Psychosis, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The purpose of this trial is to explore parent-child interactions in parents with and without psychosis, and ascertain whether a brief (10 week) supported self-help parenting program offered to parents in their own homes can help improve parents' self-efficacy and general well-being, as well as interpretations of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Psychosis, Schizophrenia
- What is being tested?
- Triple P Positive Parenting Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Jul 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of ICD-10 schizophrenia-spectrum diagnosis (F20-29).
- Primary parental caregiver for index child. This includes 10 hours of contact time with their child.
- Over 18 years of age.
- Have at least one child aged 3-10 years old.
- Identify difficulties in parenting during assessment.
- Proficient in written and spoken English.
- Capacity to provide informed consent.
Who cannot join
- Parents with a schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care, and have less than four weeks of stabilisation. This will enable the individual sufficient time to readjust to living in the community and ensure symptom stabilisation before taking part in a study.
- Parents who have no regular contact with the index child or where there is known intention for their child to be removed.
- Parents who present with child protection of safeguarding issues.
- Parents seeking or receiving support from services regarding child management issues.
- Parents actively involved in other structured programmes.
- Inclusion Criteria matched comparison group of parents for stage 1
Show all 20Show fewer
- The comparison group of parents will be matched for age, education, socioeconomic status and family composition where possible
- No previous history of psychotic illnesses.
- Primary parental caregiver for index child. This includes 10 hours of contact time with their child.
- Over 18 years of age.
- Have at least one child aged 3-10 years old.
- Identify difficulties in parenting during assessment.
- Proficient in written and spoken English.
- Capacity to provide informed consent.
- Parents with schizophrenia-spectrum symptoms, diagnosis or history.
- Parents who have no regular contact with the index child or where there is known intention for their child to be removed.
- Parents seeking support from services regarding child management issues.
- Parents actively involved in other structured programmes.
- Parents/caregivers 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 and to read and complete questionnaires.
- Insufficient language or cognitive ability to participant fully or provide informed consent.
Trial locations and contacts
1 site in 1 country.
Lauren Stockton contact
United Kingdom1 site, 1 recruiting
- Recruiting
The University of Manchester
Manchester, Lancashire, M139PL
Lauren Stockton, 01613062619
Lauren Stockton
About this study
Official title: STAGE 1: Investigating Attributions and Expressed Emotion in Parents With and Without Psychosis STAGE 2: Investigating the Use of a Self-directed Parenting Programme With Parents Experiencing Psychosis
The purpose of this trial is to explore parent-child interactions in parents with and without psychosis, and ascertain whether a brief (10 week) supported self-help parenting program offered to parents in their own homes can help improve parents' self-efficacy and general well-being, as well as interpretations of their parent-child relationship and child behaviour in children who are 3-10 years old.
Read the detailed description
The trial will be split into two stages.
Stage 1: Parents with no history of serious mental health problems and parents who have a history of psychosis or schizophrenia, who have children aged 3-10 years old, will take part in the Revised Five Minute Speech Sample (FMSS) and the Modified Camberwell Family Interview (CFI). They will also complete various measures looking at parental well-being, depression, anxiety and stress as well as parenting behaviours and interpretations of their child behaviour. In addition the PANSS interview will also be used. These interviews will be coded to investigate attributional patterns.
Stage 2: Parents who are experiencing psychosis, who took part in stage 1 will proceed to stage 2 if they want to. Parents will be seen weekly and take part in a guided self-help parenting intervention. This will require weekly visits over 10 weeks to the parents. During this time, symptoms, mood, general well-being and parenting behaviours will be monitored.
There will be no randomisation: all parents experiencing psychosis will receive the intervention.
Children do not attend the sessions, but it is hoped that parents practice the skills learned.
- Conditions
- Parenting, Psychosis, Schizophrenia
- Being tested
- Triple P Positive Parenting Programme
- Keywords
- Mental Health, Psychosis, Parent
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple P Positive Parenting ProgrammeBehavioural
10 week self-directed (guided) parenting intervention promoting self-belief, parenting confidence/self-efficacy and problem solving skills.
| Study group | Role | What they receive |
|---|---|---|
| Stage 2 Parents experiencing psychosis | Experimental | Parents all receive the self-directed Triple P Positive Parenting Programme Receives: Behavioral: Triple P Positive Parenting Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
Assessment of parental symptoms, mood, behaviours, aswell as social performance and depression
Measured: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Five Minute Speech Sample (FMSS)
Assessment of Expressed Emotion using a 5 minute uninterrupted interview
Measured: Initial Ax, End Ax, Follow up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Modified Camberwell Family Interview (CFI)
In depth assessment of Expressed Emotion using a modified version of the CFI. This version is for parents of well children.
Measured: Initial Ax only
Secondary outcomes (5)
Depression, Anxiety and Stress Scale (DASS-21)
Self-reported depression, anxiety and stress using a short form scale
Measured: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Self-reported general well-being
Measured: Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Eyberg Child Behaviour Inventory (ECBI)
Parents self-reported child problem behaviour
Measured: Initial Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Strengths and Difficulties Questionnaire (SDQ)
Parents self-reported child behaviour assessing different aspects of behaviour, e.g.,: emotional symptoms, conduct problems, hyperactivity/inattention.
Measured: Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Parenting and Family Adjustment Scale (PAFAS)
An assessment of parenting skills and family relationships.
Measured: Baseline, 1, 5, 10, follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Stockton, University of Manchester
- Investigators
- Lauren Stockton, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02622048
- Sponsor's protocol ID
- 15209: 15/NW/0532
- Status last verified
- Jun 2016
- First submitted
- 20 Nov 2015
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAGE 1: Investigating Attributions and Expressed Emotion in Parents With and Without Psychosis STAGE 2: Investigating the Use of a Self-directed Parenting Programme With Parents Experiencing Psychosis
- ClinicalTrials.gov ID
- NCT02622048
- Acronym / sponsor ID
- 15209: 15/NW/0532
- Conditions
- Parenting, Psychosis, Schizophrenia
- Keywords
- Mental Health, Psychosis, Parent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 4 Dec 2015 (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 purpose of this trial is to explore parent-child interactions in parents with and without psychosis, and ascertain whether a brief (10 week) supported self-help parenting program offered to parents in their own homes can help improve parents' self-efficacy and general well-being, as well as interpretations of their parent-child relationship and child behaviour in children who are 3-10 years old.
Detailed description
The trial will be split into two stages.
Stage 1: Parents with no history of serious mental health problems and parents who have a history of psychosis or schizophrenia, who have children aged 3-10 years old, will take part in the Revised Five Minute Speech Sample (FMSS) and the Modified Camberwell Family Interview (CFI). They will also complete various measures looking at parental well-being, depression, anxiety and stress as well as parenting behaviours and interpretations of their child behaviour. In addition the PANSS interview will also be used. These interviews will be coded to investigate attributional patterns.
Stage 2: Parents who are experiencing psychosis, who took part in stage 1 will proceed to stage 2 if they want to. Parents will be seen weekly and take part in a guided self-help parenting intervention. This will require weekly visits over 10 weeks to the parents. During this time, symptoms, mood, general well-being and parenting behaviours will be monitored.
There will be no randomisation: all parents experiencing psychosis will receive the intervention.
Children do not attend the sessions, but it is hoped that parents practice the skills learned.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage 2 Parents experiencing psychosis | Experimental | Behavioral: Triple P Positive Parenting ProgrammeParents all receive the self-directed Triple P Positive Parenting Programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of ICD-10 schizophrenia-spectrum diagnosis (F20-29).
- Primary parental caregiver for index child. This includes 10 hours of contact time with their child.
- Over 18 years of age.
- Have at least one child aged 3-10 years old.
- Identify difficulties in parenting during assessment.
Key exclusion criteria (20 listed)
- Parents with a schizophrenia-spectrum diagnosis who have recently been discharged from acute in-patient care, and have less than four weeks of stabilisation. This will enable the individual sufficient time to readjust to living in the community and ensure symptom stabilisation before taking part in a study.
- Parents who have no regular contact with the index child or where there is known intention for their child to be removed.
- Parents who present with child protection of safeguarding issues.
- Parents seeking or receiving support from services regarding child management issues.
- Parents actively involved in other structured programmes.
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 Programme10 week self-directed (guided) parenting intervention promoting self-belief, parenting confidence/self-efficacy and problem solving skills. | Behavioural | Stage 2 Parents experiencing psychosis |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Assessment of parental symptoms, mood, behaviours, aswell as social performance and depression
Five Minute Speech Sample (FMSS)
Time frame: Initial Ax, End Ax, Follow up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Assessment of Expressed Emotion using a 5 minute uninterrupted interview
Modified Camberwell Family Interview (CFI)
Time frame: Initial Ax only
In depth assessment of Expressed Emotion using a modified version of the CFI. This version is for parents of well children.
5 secondary outcomes
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Eyberg Child Behaviour Inventory (ECBI)
Time frame: Initial Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Parenting and Family Adjustment Scale (PAFAS)
Time frame: Baseline, 1, 5, 10, follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.
Lauren Stockton contact
Lauren Stockton principal investigator
The 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 Triple P Positive Parenting Programme in people with Parenting and Psychosis, 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 7 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 8 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren Stockton (07939563467, lauren.stockton@postgrad.manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: Initial Ax, Multiple Baseline Ax, Final Baseline Ax, 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up). The study lists 3 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 8 Jun 2016.