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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02199704
Other study ID # 14/NW/0126
Secondary ID
Status Completed
Phase N/A
First received July 22, 2014
Last updated July 31, 2016
Start date June 2014
Est. completion date November 2014

Study information

Verified date November 2015
Source University of Manchester
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of the case series study is to explore if a self directed version of the Positive Parenting Program (Triple P) is a feasible and acceptable intervention for individuals with psychosis who are parents.


Description:

As above.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Other:
Self Directed Positive Parenting Program
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.

Locations

Country Name City State
United Kingdom University of Manchester Manchester

Sponsors (2)

Lead Sponsor Collaborator
University of Manchester Lancashire Care NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Psychotic Symptom Rating Scales (PSYRATS) Ax from 0 - 16 weeks. Initial Ax, Multiple Baseline Ax, Final Baseline Ax, Up to 10 support sessions Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks. No
Primary Parenting and Family Adjustment Scale (PAFAS) Ax from 0 - 16 weeks. Initial Ax, Multiple Baselines, Final Baseline, Support Sessions, End Ax, Follow Up. Ax from 0 - 16 weeks. No
Secondary Eyberg Child Behaviour Inventory (ECBI) Ax from 0 - 16 weeks. Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks. No
Secondary Parenting Task Checklist (PTC) Ax from 0 - 16 weeks. Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks. No
Secondary Depression Anxiety and Stress Scale (DASS-21) Ax from 0 - 16 weeks. Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks. No
Secondary Work and Social Adjustment Scale (WSAS) Ax from 0 - 16 weeks. Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks. No
Secondary Warwick-Edinburgh Mental Well-being Scale (WEMWBS) Ax from 0 - 16 weeks. Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks. No
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