NCT02151955

Brief Summary

Following an exploratory project, funded by Guys and St Thomas' Charity between September 2010- November 2011, of the first combined mental health screening and intervention project for \<5 Children in Care (CiC) in the UK, the current study will expand this work by a) developing a feasibility study to assess both longer term interventions and outcomes for this group and b) extending the model to two further vulnerable groups of young children. The three groups of children aged 3 months to 3 years (\<4's) in Southwark include:

  1. 1.Children who become newly looked after (CiC)
  2. 2.Children of parents referred to Parental Mental Health team (PMH)
  3. 3.Children on Child Protection (CP) Plans

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

2.4 years

First QC Date

April 14, 2014

Last Update Submit

November 9, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Keys to Interactive Parenting Scale (KIPS)

    The main outcome measure that will be used to determine the acceptability and feasibility of the screening and intervention across all three of our high risk groups is the Keys to Interactive Parenting Scale (KIPS, 2011). KIPS is a reliable, evidence based tool to effectively measure parenting behaviours. Twelve aspects of parenting (e.g. sensitivity of responses, physical interaction, involvement in child's activities, adapts strategies to child) are rated on a 5 point scale, following a 20 minute observation of the parent or carer interacting with the child.

    Participants will be assessed at baseline and at 26 weeks

Secondary Outcomes (3)

  • The Ages and stages Questionnaire Social Emotional (ASQ:SE 2003)

    Participants will be assessed at baseline and at 26 weeks

  • Representational measures of Mindmindedness in preschoolers (Meins, 1998)

    Participants will be assessed at baseline and at 26 weeks

  • Child and Adolescent Service use Schedule (CASUS)

    Participants will be assessed at baseline and at 26 weeks

Study Arms (1)

Individual parent infant intervention

EXPERIMENTAL

Children and parents will be offered an assessment and then a tailored individual 10 to 15 week based attachment and parent intervention to promote parent child relationship.

Behavioral: Individual

Interventions

IndividualBEHAVIORAL

10 to 15 Individual parent child therapeutic intervention focusing on the quality of the parent child relationships using attachment theory and parent infant psychotherapy

Individual parent infant intervention

Eligibility Criteria

Age3 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who have newly come into care (CiC) where their parents have given informed consent and foster carers have given informed consent
  • Children whose parents have been referred to the Parental Mental Health team (PMH) where parents have been assessed by the PMH team and are engaged with an identified parental mental health worker.
  • Children who are new to a Child Protection Plan where their parents have given informed consent

You may not qualify if:

  • Children who have newly come into care (CiC) whose foster carers live so far away geographically as to make it impractical to deliver the intervention.
  • children whose families have been offered a place in the Family Drug and Alcohol Service.
  • when English language is not sufficient to engage in intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carelink, Lister Health Centre, 101 Peckham Road

London, London, SE15 5LJ, United Kingdom

Location

Study Officials

  • Elizabeth Murphy, MSc

    South London & Maudsley NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Child & Adolescent Psychotherapist

Study Record Dates

First Submitted

April 14, 2014

First Posted

June 2, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations