Back to resultsUnderstanding and Helping Families: Parents With Psychosis
Primary Purpose
Parenting, Psychosis, Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Triple P Positive Parenting Programme
Sponsored by
About this trial
This is an interventional supportive care trial for Parenting focused on measuring Mental Health, Psychosis, Parent
Eligibility Criteria
Inclusion Criteria for parents with psychotic illnesses
- 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.
Exclusion Criteria for parents with psychotic illnesses
- 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
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.
Exclusion Criteria for comparison group
- 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.
Sites / Locations
- The University of ManchesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stage 2 Parents experiencing psychosis
Arm Description
Parents all receive the self-directed Triple P Positive Parenting Programme
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Assessment of parental symptoms, mood, behaviours, aswell as social performance and depression
Five Minute Speech Sample (FMSS)
Assessment of Expressed Emotion using a 5 minute uninterrupted interview
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.
Secondary Outcome Measures
Depression, Anxiety and Stress Scale (DASS-21)
Self-reported depression, anxiety and stress using a short form scale
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Self-reported general well-being
Eyberg Child Behaviour Inventory (ECBI)
Parents self-reported child problem behaviour
Strengths and Difficulties Questionnaire (SDQ)
Parents self-reported child behaviour assessing different aspects of behaviour, e.g.,: emotional symptoms, conduct problems, hyperactivity/inattention.
Parenting and Family Adjustment Scale (PAFAS)
An assessment of parenting skills and family relationships.
Full Information
NCT ID
NCT02622048
First Posted
November 20, 2015
Last Updated
June 7, 2016
Sponsor
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT02622048
Brief Title
Understanding and Helping Families: Parents With Psychosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parenting, Psychosis, Schizophrenia
Keywords
Mental Health, Psychosis, Parent
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stage 2 Parents experiencing psychosis
Arm Type
Experimental
Arm Description
Parents all receive the self-directed Triple P Positive Parenting Programme
Intervention Type
Behavioral
Intervention Name(s)
Triple P Positive Parenting Programme
Intervention Description
10 week self-directed (guided) parenting intervention promoting self-belief, parenting confidence/self-efficacy and problem solving skills.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
Assessment of parental symptoms, mood, behaviours, aswell as social performance and depression
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
Title
Five Minute Speech Sample (FMSS)
Description
Assessment of Expressed Emotion using a 5 minute uninterrupted interview
Time Frame
Initial Ax, End Ax, Follow up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Title
Modified Camberwell Family Interview (CFI)
Description
In depth assessment of Expressed Emotion using a modified version of the CFI. This version is for parents of well children.
Time Frame
Initial Ax only
Secondary Outcome Measure Information:
Title
Depression, Anxiety and Stress Scale (DASS-21)
Description
Self-reported depression, anxiety and stress using a short form scale
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
Title
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Description
Self-reported general well-being
Time Frame
Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Title
Eyberg Child Behaviour Inventory (ECBI)
Description
Parents self-reported child problem behaviour
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
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
Parents self-reported child behaviour assessing different aspects of behaviour, e.g.,: emotional symptoms, conduct problems, hyperactivity/inattention.
Time Frame
Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
Title
Parenting and Family Adjustment Scale (PAFAS)
Description
An assessment of parenting skills and family relationships.
Time Frame
Baseline, 1, 5, 10, follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for parents with psychotic illnesses
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.
Exclusion Criteria for parents with psychotic illnesses
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
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.
Exclusion Criteria for comparison group
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Stockton
Phone
07939563467
Email
lauren.stockton@postgrad.manchester.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Stockton
Email
l.stockton1525@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Stockton
Organizational Affiliation
The University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Manchester
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M139PL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Stockton
Phone
01613062619
First Name & Middle Initial & Last Name & Degree
Lauren Stockton
12. IPD Sharing Statement
Learn more about this trial
Understanding and Helping Families: Parents With Psychosis
We'll reach out to this number within 24 hrs