NCT02199704

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 2, 2016

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

July 22, 2014

Last Update Submit

July 31, 2016

Conditions

Keywords

ParentingPsychosisSchizophreniaDelusionsHallucinations

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Secondary Outcomes (5)

  • Eyberg Child Behaviour Inventory (ECBI)

    Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.

  • Parenting Task Checklist (PTC)

    Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.

  • Depression Anxiety and Stress Scale (DASS-21)

    Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.

  • Work and Social Adjustment Scale (WSAS)

    Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.

  • Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    Initial Ax, Final Ax, End Ax, Follow Up. Ax from 0 - 16 weeks.

Study Arms (1)

No control or comparison arm.

OTHER

This case series study has no control or comparison arm. There is only one arm being evaluated (the self directed parenting intervention).

Other: Self Directed Positive Parenting Program

Interventions

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.

Also known as: "Every Parent's Self Help Workbook"
No control or comparison arm.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Parents/caregivers (mothers or fathers) with a Schizophrenia-spectrum diagnosis who are:
  • \. Aged 18 years or more
  • \. Have at least one child aged 3-10 years old
  • \. Have a least 10 hours contact time per week with the child.
  • \. Identify difficulties in parenting during assessment

You may not qualify if:

  • \. 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
  • \. Families who do not have at least one adult who has basic literacy skills
  • \. 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
  • \. 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
  • \. Families seeking support from services regarding child management issues
  • \. Families actively involved in another current cognitive behavioural therapy based intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

SchizophreniaDiseasePsychotic DisordersDelusionsHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Prof Rachel Calam, PhD

    University of Manchester

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 24, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 2, 2016

Record last verified: 2015-11

Locations