NCT06195579

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

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

Study Start

First participant enrolled

June 27, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 5, 2024

Completed
Last Updated

August 5, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

December 22, 2023

Results QC Date

February 20, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

child behavioural problemsparent trainingNurtured Heart Approachguided self-helpsingle case design

Outcome Measures

Primary Outcomes (2)

  • Parent-reported Child Behavioural Problems

    Results state the number of children for whom parents reported an improvement in behaviour 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)

  • Idiographic Measure of Parent-perceived Problems

    Results state the number of children for whom parents reported an improvement on the ideographic goals set by parents. Measured using the PSYCHLOPS (Ainsworth et al., 2009)

    Measured at the beginning of the baseline and follow up (one month post intervention)

Secondary Outcomes (3)

  • Negative Parenting Practices

    Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)

  • Parental Reflective Functioning

    Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)

  • Parental Wellbeing

    Measured at the beginning of the baseline and follow up (one month post intervention)

Study Arms (1)

Intervention arm

EXPERIMENTAL

Participants receiving the intervention whilst on a waiting list for treatment as usual

Behavioral: Transforming the Intense Child Workbook (Glasser, 2016)

Interventions

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

Intervention arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lincoln

Lincoln, Lincolnshire, LN5 7AT, United Kingdom

Location

Limitations and Caveats

The study included no observational element, meaning there is no measure of the extent to which parents were using the NHA in interactions with their children. The study also highlights the limitations of measures used for the variables of interest e.g. the BPM has limited items related to externalizing behaviour but alternative measures were not appropriate for a single case design. The limitations of the measures require the results to be interpreted in the context of these shortcomings.

Results Point of Contact

Title
Dr Nima Moghaddam
Organization
University of Lincoln

Study Officials

  • Nima Moghaddam

    University of Lincoln

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single case design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2023

First Posted

January 8, 2024

Study Start

June 27, 2022

Primary Completion

February 28, 2023

Study Completion

September 30, 2023

Last Updated

August 5, 2024

Results First Posted

August 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations