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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06195579
Other study ID # 22004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2022
Est. completion date September 30, 2023

Study information

Verified date December 2023
Source University of Lincoln
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Behavioural problems are prevalent in children, yet the consequences can be significant for the child, family and wider society. Effective intervention is paramount in reducing the impact of childhood behavioural problems. The Nurtured Heart Approach (NHA; Glasser & Easley, 2016) is an atheoretical parenting intervention which aims to reduce childhood behavioural problems. Although used in clinical practice, there is little empirical research on the effectiveness of the NHA. The aims of the study were to examine whether the NHA reduced parent-reported child behavioural problems, reduced negative parenting practices, and increased parental reflective functioning. The study used a multiple baseline single case design. Parents of children with behavioural problems were recruited from CAMHS waiting lists. The NHA was delivered in a guided self-help format, using the Transforming the Intense Child workbook (Glasser, 2016) and weekly phone calls. Data collection involved psychometric measures of parent-reported child behavioural problems, parenting practices and parental reflecting functioning. Measures were repeated throughout baseline and intervention phases. A follow-up four weeks after the intervention included final measure administration and a change interview. The data were graphed and visually analysed. Supplementary analysis included reliable and clinically significant change, Tau-U and percentage exceeding the median. Framework analysis was used to analyse the change interview.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date September 30, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Participants will be parents/carers of children who have been referred to National Health Service (NHS) children's services for behavioural problems. Participants will be recruited from waiting lists of NHS children's services at the two research sites in the East Midlands. Inclusion criteria: - The referred child is aged between three and eleven years old. - The referred child is on a waiting list for an NHS children's service at the two research sites. - The referred child's behavioural problems are one of the primary reasons for referral to the NHS service. - The parent/carer identifies the referred child's behaviour as problematic. Exclusion Criteria: - The referred child has a diagnosis of developmental delay or learning disability. - The family is current receiving active multi-agency involvement (e.g. social care, police or youth offending in addition to NHS services). - The parent/carer is aged under 18. - The parent/carer is unable to read or speak English fluently.

Study Design


Intervention

Behavioral:
Transforming the Intense Child Workbook (Glasser, 2016)
The NHA was delivered in a guided self-help format, using the Transforming the Intense Child workbook (Glasser, 2016) and weekly phone calls.

Locations

Country Name City State
United Kingdom University of Lincoln Lincoln Lincolnshire

Sponsors (1)

Lead Sponsor Collaborator
University of Lincoln

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent-reported child behavioural problems Measured using the Brief Problem Monitor (Achenbach et al., 2011) Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Primary Idiographic measure of parent-perceived problems Measured using the PSYCHLOPS (Ainsworth et al., 2009) Measured at the beginning of the baseline and follow up (one month post intervention)
Secondary Negative parenting practices Measured using the Multidimensional Assessment of Parenting Scale (Parent and Forehand, 2017) Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Secondary Parental reflective functioning Measured using the Parental Reflective Functioning Questionnaire (Luyten et al., 2017) Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Secondary Parental wellbeing Measured using the SWEMWBS (Tennanet et al., 2007) Measured at the beginning of the baseline and follow up (one month post intervention)
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