Clinical trial NCT02622048: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parenting
Psychosis
Schizophrenia
Keywords: Mental Health
Psychosis
Parent
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria for parents with psychotic illnesses

1. Presence of ICD-10 schizophrenia-spectrum diagnosis (F20-29).
2. Primary parental caregiver for index child. This includes 10 hours of contact time with their child.
3. Over 18 years of age.
4. Have at least one child aged 3-10 years old.
5. Identify difficulties in parenting during assessment.
6. Proficient in written and spoken English.
7. Capacity to provide informed consent.

Exclusion Criteria for parents with psychotic illnesses

1. 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.
2. Parents who have no regular contact with the index child or where there is known intention for their child to be removed.
3. Parents who present with child protection of safeguarding issues.
4. Parents seeking or receiving support from services regarding child management issues.
5. 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

1. No previous history of psychotic illnesses.
2. Primary parental caregiver for index child. This includes 10 hours of contact time with their child.
3. Over 18 years of age.
4. Have at least one child aged 3-10 years old.
5. Identify difficulties in parenting during assessment.
6. Proficient in written and spoken English.
7. Capacity to provide informed consent.

Exclusion Criteria for comparison group

1. Parents with schizophrenia-spectrum symptoms, diagnosis or history.
2. Parents who have no regular contact with the index child or where there is known intention for their child to be removed.
3. Parents seeking support from services regarding child management issues.
4. Parents actively involved in other structured programmes.
5. 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.
6. Insufficient language or cognitive ability to participant fully or provide informed consent.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 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
measure: Five Minute Speech Sample (FMSS)
timeFrame: Initial Ax, End Ax, Follow up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
measure: Modified Camberwell Family Interview (CFI)
timeFrame: Initial Ax only
Secondary outcomes:
measure: Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: 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
measure: Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
timeFrame: Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
measure: Eyberg Child Behaviour Inventory (ECBI)
timeFrame: 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
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up
measure: Parenting and Family Adjustment Scale (PAFAS)
timeFrame: Baseline, 1, 5, 10, follow up
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
state: Lancashire
Study officials:
affiliation: The University of Manchester
name: Lauren Stockton
role: PRINCIPAL_INVESTIGATOR
References: