Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02151955
Status:
COMPLETED
Last Update Posted:
2016-11-11
First Post:
2014-04-14
Brief Title:
Social-emotional Under 4s Screening Intervention SUSI
Sponsor:
South London and Maudsley NHS Foundation Trust
Organization:
South London and Maudsley NHS Foundation Trust
Study Overview
Official Title:
Social-emotional Under 4s Screening Intervention A Study of Emotional Health and Development in Babies and Young Children
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUSI
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 4s 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 childs current caregivers in relation to the child
The three groups of children aged 3 months to 3 years 4s 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 childs 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 Childrens 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 eg 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 childs current home setting
Procedure
In Group 1 birth parents will be invited to complete the Ages and Stages Questionnaire Social Emotional ASQSE to gain their view on their childs needs
The home visit screening will include the ASQ-SE interview with the childs 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 carerparent 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 childs 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 childs 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 childs 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 childs 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 participants 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 ASQSE 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 parentscarers 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 p005 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
Recruitment This research will take place in the Carelink CAMHS Looked after Childrens 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 eg 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 childs current home setting
Procedure
In Group 1 birth parents will be invited to complete the Ages and Stages Questionnaire Social Emotional ASQSE to gain their view on their childs needs
The home visit screening will include the ASQ-SE interview with the childs 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 carerparent 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 childs 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 childs 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 childs 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 childs 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 participants 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 ASQSE 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 parentscarers 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 p005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None