Nurtured Heart Parenting Intervention for Child Behavioural Problems

February 20, 2024 updated by: University of Lincoln

The Nurtured Heart Parenting Intervention for Children's Behavioural Problems: A Single Case Design

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Lincolnshire
      • Lincoln, Lincolnshire, United Kingdom, LN5 7AT
        • University of Lincoln

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention arm
Participants receiving the intervention whilst on a waiting list for treatment as usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parent-reported Child Behavioural Problems
Time Frame: Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
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
Time Frame: Measured at the beginning of the baseline and follow up (one month post intervention)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Negative Parenting Practices
Time Frame: Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Parents whose negative parenting practices reduced, 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)
Parental Reflective Functioning
Time Frame: Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Parents whose parental reflective function improved due to the intervention, 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)
Parental Wellbeing
Time Frame: Measured at the beginning of the baseline and follow up (one month post intervention)
Number of parents whose wellbeing improved when measured using the SWEMWBS (Tennanet et al., 2007).
Measured at the beginning of the baseline and follow up (one month post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Lincoln

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nima Moghaddam, University of Lincoln

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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