- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02199704
Self Directed Positive Parenting Program (Triple P) for Psychosis: A Clinical Case Series
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Manchester, United Kingdom, M13 9PL
- University of Manchester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: No control or comparison arm.
This case series study has no control or comparison arm.
There is only one arm being evaluated (the self directed parenting intervention).
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Ax from 0 - 16 weeks.
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Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks.
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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.
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Ax from 0 - 16 weeks.
|
Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eyberg Child Behaviour Inventory (ECBI)
Time Frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
|
Ax from 0 - 16 weeks.
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Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
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Parenting Task Checklist (PTC)
Time Frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
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Ax from 0 - 16 weeks.
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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.
|
Ax from 0 - 16 weeks.
|
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.
|
Ax from 0 - 16 weeks.
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Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
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Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time Frame: Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
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Ax from 0 - 16 weeks.
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Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Prof Rachel Calam, PhD, University of Manchester
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/NW/0126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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