NCT02622048

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

November 20, 2015

Last Update Submit

June 7, 2016

Conditions

Keywords

Mental HealthPsychosisParent

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (5)

  • Depression, Anxiety and Stress Scale (DASS-21)

    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

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

    Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up

  • Eyberg Child Behaviour Inventory (ECBI)

    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

  • Strengths and Difficulties Questionnaire (SDQ)

    Initial Ax, Final Baseline Ax, End Ax, Follow Up Ax. Ax from 0 - 16 weeks with 3 and 6 month follow up

  • Parenting and Family Adjustment Scale (PAFAS)

    Baseline, 1, 5, 10, follow up

Study Arms (1)

Stage 2 Parents experiencing psychosis

EXPERIMENTAL

Parents all receive the self-directed Triple P Positive Parenting Programme

Behavioral: Triple P Positive Parenting Programme

Interventions

10 week self-directed (guided) parenting intervention promoting self-belief, parenting confidence/self-efficacy and problem solving skills.

Stage 2 Parents experiencing psychosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Manchester

Manchester, Lancashire, M139PL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaPsychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Lauren Stockton

    The University of Manchester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Clinical Psychology Student

Study Record Dates

First Submitted

November 20, 2015

First Posted

December 4, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations