Social-emotional Under 4's Screening & Intervention S.U.S.I.
Condition: Parent Child Relationships; Parent Child Interactions; Child Development
Study type: Interventional

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. Children who become newly looked after (CiC)

        2. Children of parents referred to Parental Mental Health team (PMH)

        3. Children on Child Protection (CP) Plans

      Parents will be invited to take part in the study if their children are eligible within the
      groups above. Informed consent will be obtained at the outset.

      Hypothesis;

      The investigators aim to implement a method of screening that will identify socioemotional
      and mental health needs in infants and young children, aged 0-3 years of age, across three
      high risk cohorts (Children in Care, children on a Child Protection Plan, children of parents
      with mental health difficulties).

      Is it feasible to deliver an early treatment intervention that positively impacts on the
      difficulties identified, by providing specific emotional, social and mental health support
      and advice to the child's current caregivers in relation to the child.
    

Detailed description: 
      The purpose of the feasibility study is to evaluate the impact of specific mental health
      interventions for the children, parents and carers in three high risk groups of children
      under the age of 4 years.

      Recruitment This research will take place in the Carelink, CAMHS Looked after Children's
      team.

      A brief introduction to the research will be sent with relevant appointment information to
      the parents in all groups stating that they may be approached by a researcher at a particular
      time (e.g at a scheduled Contact, a CP conference, appointment with their keyworker). The
      letter will say that the researcher will be making contact to discuss details of the research
      at an agreed and convenient date for the parents. It will make clear that participation is
      voluntary. We have made the letter as brief and clear as possible because parents may have
      difficulty processing information like this at a stressful time.

      If the birth parents agree to meet with a CAMHS research practitioner, it will give them an
      opportunity to ask any questions and to discuss the study in detail to facilitate informed
      consent. Also at the meeting we will set up a time for the first screening visit to take
      place once parent have confirmed their participation.

      We will inform all keyworkers when a family gives informed consent to participate in the
      study.

      For all the groups, screening will take place over two home visits (unless parents or carers
      particularly wish to meet in an alternative location) that will last approximately one hour
      each. The screening visits will take place in the child's current home setting.

      Procedure:

      In Group 1 birth parents will be invited to complete the Ages and Stages Questionnaire:
      Social Emotional (ASQ:SE) to gain their view on their child's needs.

      The home visit screening will include the ASQ-SE interview with the child's foster or kinship
      carer (Group 1) or parent (Groups 2 and 3) followed by the Keys to Interactive Parenting
      Scale (KIPS) free play observation of the child and carer/parent. The KIPS observation will
      be videoed, if we gain specific consent to do so, or will be coded from the live observation
      if the parent or carer does not wish to be videoed. We will also administer the
      Mind-mindedness measure (MM) and a language scale. The DASS will also be completed with the
      birth parents in Groups 2 and 3.

      Additional information may be gained regarding the child's health and development from the
      Child Health service, gathered in either the child statutory initial health assessment (IHA)
      for Group 1, or if a child has been referred for a health or developmental check for Groups 2
      and 3.

      Interventions:

      The detailed information from the screening process will be used to inform specific strengths
      and needs in relation to both the individual child and the parents or caregivers which will
      then guide the intervention plan to be agreed with the parent or caregiver according to the
      cohort (Groups 1-3). The intervention will primarily aim to promote healthy child
      development, responsive parenting behaviours and positive cycles of carer-child relations.

      Six month review screenings will take place with all families; the children and their carers
      who join the study and have completed the screening in the first 9 month period will have two
      review screenings and those joining after this time will have one review. The review
      screenings will follow the same structure as the initial screening and all the measures will
      be completed in order that outcomes for the child and child-carer relationship can be
      obtained.

      In addition, information on the child's use of health and social care services will be
      collected from families, using the CA-SUS, at the 6 and 12-month follow-up points, to allow
      assessment of the cost of the screening and intervention and exploration of factors that
      influence the economic burden.

      Evaluation:

      We hypothesize that screening may pick up undetected or misunderstood social-emotional,
      developmental and attachment difficulties, and in a small number of cases specific mental
      health disorders in the children. We also expect to gain a greater understanding of the areas
      of difficulty in key aspects of the child's relationship with primary caregivers. By
      intervening early to specifically address the issues identified in the screening we hope the
      intervention will impact positively on both the quality of the carer-child relationship as
      well as the child's social-emotional development. In addition, we anticipate that the close
      interagency collaboration developed in the study will positively impact on the care planning
      and decision-making around the child taking place in a timely fashion.

      Data already collected from the parent or the child will be retained in identifiable form and
      used in the research. This is important as it will give the research team further information
      about this high risk group and their vulnerable parents. This will be made clear in the
      consent procedure.

      Study participants will be assigned an alphanumerical study identification number at the time
      of providing consent. The ID number will be used on study electronic databases,
      questionnaires and report forms. The study identification number will be recorded on the
      consent form (which will have the participant's full name). Participant contact details will
      be needed for the duration of the study and will be kept together with the paper study
      records in locked cabinets of locked offices of a secure NHS building.

      Copies of written reports, correspondence and process recordings from the screening and
      intervention will be stored on the password protected 'u' drive of Trust computers.

      A Research Consultant and Health Economics Consultant will coordinate the analysis of the
      data by research staff employed in the study. All information will be stored on a secure data
      base.

      Differences on level of uptake of the screening, the proportion of families and carers who
      engage in treatments offered and the prevalence and types of difficulties in all three groups
      will be examined using Chi Square tests of association. Comparison of scores on the KIPS,
      ASQ:SE and Mind mindedness measures will be made between high risk groups before and after
      the intervention using t-tests and both univariate and multivariate analyses of variance.
      Comparisons of scores will be made between type of intervention offered using t-tests. Other
      outcomes, such as a comparison of the views of contact workers before and after the new
      system is implemented and decision timescales before and during the project will be made
      using the Chisquare tests of association and t-tests.

      Qualitative feedback from birth parents, foster carers, kinship carers and professionals on
      the usefulness of the screening process and interventions will be analysed using information
      collected on feedback questionnaires designed for the study.

      The economic evaluation will involve: 1) Calculation of the cost of all interventions
      provided as part of the proposed work; 2) Description of and calculation of the total cost of
      all other health and social care services used; and 3) Exploration of characteristics of the
      participants and their family that influence the economic burden.

      Data on the use of all hospital and community health and social care services will be
      collected using the Child and Adolescent Service Use Schedule (CASUS), administered in
      interview with parents/carers at the 6 and 12month followups.

      Information on the use of the intervention in each of the three groups will be collected
      directly from therapist records. The interventions under evaluation will be costed using a
      standard microcosting approach (Drummond et al, 2005) on the basis of the salary of the
      therapist plus appropriate overhead expenses (administrative, managerial and capital).
      Calculation of indirect time, including preparation and supervision, will be based on
      information provided by the therapists on the ratio of direct face to face contact to other
      activities Nationally applicable unit costs will be applied to all other services used
      (Curtis, 2012).

      Service use and cost for each of the three populations will be reported descriptively (mean,
      standard deviation, median and range) to explore the cost burden of each. Prior to
      statistical analysis we will generate hypotheses about factors likely to influence service
      use and cost drawing on evidence from a review of the literature and expert opinion from the
      research team. Only a limited number of hypothesis driven predictors will be selected from
      the available baseline characteristics of study participants in order to avoid finding
      associations by chance. In line with previous research (Byford et al, 2001; Barrett et al,
      2012), univariate associations between the specified factors and total health and social care
      costs will be examined using linear regression. Multiple regression will then be used to
      reduce the variable set to those factors independently associated with cost. This will
      initially include those variables found to have significant univariate associations and
      discarding those that cease to be important. Each variable that does not have a univariate
      association with costs will be added, one at a time, and retained if it adds significantly to
      the model or otherwise discarded. This will ensure that none of the excluded factors would
      add significantly to the model. We will use a significance level of p≤0.05 (5%). Standard
      ordinary least squares regression will be used on untransformed costs, despite the skewed
      distribution of the cost data, because this enables inferences to be made about the
      arithmetic mean (Barber & Thompson, 1998). The results of the model will be checked through
      comparison with a nonparametric bootstrap regression, to assess the robustness of the
      confidence intervals and p values to non-normality of the cost distribution, and with a
      generalised linear model, with a non-normal gamma distribution assumed for costs (Blough et
      al, 1999).
    

Intervention name(s): Individual
Intervention type(s): Behavioral
Intervention description(s): 10 to 15 Individual parent child therapeutic intervention focusing on the quality of the parent child relationships using attachment theory and parent infant psychotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment