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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 22 February 2021
Main ID:  ISRCTN13644600
Date of registration: 03/06/2015
Prospective Registration: No
Primary sponsor: Maynooth University
Public title: An evaluation of a wraparound intervention for families whose children are at risk of abuse and/or neglect
Scientific title: A randomised controlled trial evaluation, cost-effectiveness study and process evaluation of a wraparound programme to improve psychosocial outcomes for families whose children at risk of abuse and/or neglect.
Date of first enrolment: 15/05/2015
Target sample size: 150
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN13644600
Study type:  Interventional
Study design:  Randomised controlled trial, process evaluation and analysis (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Ireland
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Sinead     McGilloway
Address:  Department of Psychology John Hume Building (Floor 2) North Campus Maynooth University - Maynooth, Co. Kildare Ireland
Telephone: 00353 1 7086052
Email: Sinead.McGilloway@nuim.ie
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. Participants are parents/caregivers (both genders) of children aged 3-10 years (both genders) where:
1.1. The child has been identified by a child welfare professional within a collaborating agency (e.g. social work team) as being at risk of abuse or neglect; or
1.2. Where it is known by the social work team that a level of child maltreatment has occurred, but the child is still living within the home (i.e. not placed in state care)

The child’s level of risk will be judged according to Levels 2 to 4 in line with the guidance contained in the document entitled ‘Thresholds for referral to Tusla Social Work services’. This document is based on the Hardiker model.

2. Parents/caregivers must be judged by the social work team to be stable in terms of substance use, domestic violence or mental illness so that they have the capacity to engage for the duration of the intervention
3. In cases where families, and particularly high risk families, are on mandatory child protection plans and are allocated to the control group, they must be provided with interim support from their allocated social care leader/key worker until they receive the wraparound intervention. This support may involve usual services such as individual therapy, as well as referral to services that are not part of the ‘core’ wraparound intervention
4. Parents/families must be willing and able to attend the services offered
5. Parents/families must agree to participate in the research

Exclusion criteria:
1. Families who display unstable substance use or mental illness will be excluded as will those who are considered to be unstable due to domestic violence issues
2. Families who have had prior exposure to an evidence-based parenting programme will be excluded


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Child abuse and neglect
Mental and Behavioural Disorders
Intervention(s)
The Children At Risk Model (ChARM) is a wraparound programme that combines a range of supports to address the health and social care needs of families where children (3-10 years) are at risk of abuse and/or neglect. The supports involve a ‘core’ programme which comprises a life skills programme, parent-training, and home visiting by a mental health professional. Other additional services will also be provided as necessary (e.g. substance abuse clinic; referral of child to Child and Adult Mental Health Services, and so forth).
Primary Outcome(s)

1. Improvement in child wellbeing and behaviour - measured by the Strengths and Difficulties questionnaire (SDQ), completed by parent (and child, where appropriate) at baseline, 6-, 12- and 18-month follow up
2. Reduction in incidences of child abuse and neglect - Conflict Tactics Scale Parent Child, completed by parent at baseline, 6-, 12- and 18-month follow up
3. Reduction in child abuse potential - measured by the Brief Child Abuse Potential Inventory, competed by parent/caregiver at baseline, 6-, 12- and 18-month follow up
Secondary Outcome(s)

1. Improvement in parental mental health - measured by the Depression, Anxiety and Stress scale (DASS) and the Parenting Stress Index, both completed by parent at baseline, 6-, 12- and 18-month follow up
2. Improvement in parental alcohol and drug use - measured by the CAGE and Drug Abuse Screening Test (DAST-10) questionnaires, both completed by parent at baseline, 6-, 12- and 18-month follow up
3. Improvement in the relationship between parent and children - measured by the Parenting Stress Index (PSI) and the HOME observation. The PSI is completed by parents. The HOME is conducted by researchers observing parent-child interaction. Both measures are administered at baseline, 6-, 12- and 18-month follow up
4. Improvement in parenting competencies - measured by the HOME observation, completed by researchers observing parent-child interaction at 6-, 12-, and 18-month follow up
Secondary ID(s)
Collaborative Applied Research Grants 2012 ( CARG/2012/17 )
Source(s) of Monetary Support
Health Research Board
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
The Social Research Ethics Sub-committee in Maynooth University, Ireland, 06/02/2015, ref: SRESC-201x-xxxxx )
Results
Results available: Yes
Date Posted:
Date Completed: 10/12/2018
URL:
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