Understanding and Helping Families: Parents With Psychosis

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622048
• Other study ID #: 15209: 15/NW/0532
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2015
• Last updated: June 7, 2016
• Start date: September 2015
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: University of Manchester
• Contact: Lauren Stockton
• Phone: 07939563467
• Email: lauren.stockton[@]postgrad.manchester.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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 their parent-child relationship and child behaviour in children who are 3-10 years old.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mental Disorders
• Parenting
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Triple P Positive Parenting Programme
10 week self-directed (guided) parenting intervention promoting self-belief, parenting confidence/self-efficacy and problem solving skills.

Locations

Country	Name	City	State
United Kingdom	The University of Manchester	Manchester	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)	Assessment of parental symptoms, mood, behaviours, aswell as social performance and depression	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	No
Primary	Five Minute Speech Sample (FMSS)	Assessment of Expressed Emotion using a 5 minute uninterrupted interview	Initial Ax, End Ax, Follow up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up	No
Primary	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.	Initial Ax only	No
Secondary	Depression, Anxiety and Stress Scale (DASS-21)	Self-reported depression, anxiety and stress using a short form scale	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	No
Secondary	Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	Self-reported general well-being	Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up	No
Secondary	Eyberg Child Behaviour Inventory (ECBI)	Parents self-reported child problem behaviour	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	No
Secondary	Strengths and Difficulties Questionnaire (SDQ)	Parents self-reported child behaviour assessing different aspects of behaviour, e.g.,: emotional symptoms, conduct problems, hyperactivity/inattention.	Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up	No
Secondary	Parenting and Family Adjustment Scale (PAFAS)	An assessment of parenting skills and family relationships.	Baseline, 1, 5, 10, follow up	No