Parent-Child RelationsNCT06195579

Nurtured Heart Parenting Intervention for Child Behavioural Problems

A study testing Transforming the Intense Child Workbook (Glasser, 2016) in people with Parent-Child Relations and Child Behavior Problem, run by University of Lincoln at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Parent-Child Relations, Child Behavior Problem
What is being tested?: Transforming the Intense Child Workbook (Glasser, 2016)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited Kingdom
Study dates: 27 Jun 2022to 30 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Lincoln
Lincoln, Lincolnshire, LN5 7AT

Other trials in United Kingdom

About this study

Official title: 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.

Conditions: Parent-Child Relations, Child Behavior Problem
Being tested: Transforming the Intense Child Workbook (Glasser, 2016)
Keywords: child behavioural problems, parent training, Nurtured Heart Approach, guided self-help, single case design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06195579
Study group	Role	What they receive
Intervention arm	Experimental	Participants receiving the intervention whilst on a waiting list for treatment as usual Receives: Behavioral: Transforming the Intense Child Workbook (Glasser, 2016)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Negative Parenting Practices
Parents whose negative parenting practices reduced, measured using the Multidimensional Assessment of Parenting Scale (Parent and Forehand, 2017)
Measured: Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Parental Reflective Functioning
Parents whose parental reflective function improved due to the intervention, measured using the Parental Reflective Functioning Questionnaire (Luyten et al., 2017)
Measured: Measure across the baseline phase (3 weeks), intervention phase (6 weeks) and follow up (one month post intervention)
Parental Wellbeing
Number of parents whose wellbeing improved when measured using the SWEMWBS (Tennanet et al., 2007).
Measured: Measured at the beginning of the baseline and follow up (one month post intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 202230 Sep 2023

First posted8 Jan 2024
Study start27 Jun 2022
Primary completion28 Feb 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single case design
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06195579
Sponsor's protocol ID: 22004
Status last verified: Feb 2024
First submitted: 22 Dec 2023
Last updated: 5 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Nurtured Heart Parenting Intervention for Children's Behavioural Problems: A Single Case Design
ClinicalTrials.gov ID: NCT06195579
Acronym / sponsor ID: 22004
Conditions: Parent-Child Relations, Child Behavior Problem
Keywords: child behavioural problems, parent training, Nurtured Heart Approach, guided self-help, single case design
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: University of LincolnUniversity, hospital or other
Study start: 27 Jun 2022 (actual)
Primary completion: 28 Feb 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 8 Jan 2024 (actual)
Results: Posted 5 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single case design

Arm	Type	Receives
Intervention arm	Experimental	Behavioral: Transforming the Intense Child Workbook (Glasser, 2016)Participants receiving the intervention whilst on a waiting list for treatment as usual

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Intervention arm

Primary outcome

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).
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)

3 secondary outcomes

Negative Parenting Practices
Time frame: 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)
Parental Wellbeing
Time frame: Measured at the beginning of the baseline and follow up (one month post intervention)

Results and safety

Results posted to the registry on 5 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	6	5

Primary outcome: 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). Number. Unit: participants

Measure	Intervention Arm n = 5
Value	1

Primary outcome: Idiographic Measure of Parent-perceived Problems

Time frame: Measured at the beginning of the baseline and follow up (one month post intervention). Number. Unit: participants

Measure	Intervention Arm n = 5
Value	3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The data collection preiod - 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nima Moghaddam principal investigator

University of Lincoln

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transforming the Intense Child Workbook (Glasser, 2016) in people with Parent-Child Relations and Child Behavior Problem, run by University of Lincoln at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06195579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.