Trial Outcomes & Findings for Nurtured Heart Parenting Intervention for Child Behavioural Problems (NCT NCT06195579)

NCT ID: NCT06195579

Last Updated: 2024-08-05

Results Overview

Results state the number of children for whom parents reported an improvement in behaviour using the Brief Problem Monitor (Achenbach et al., 2011).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

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

Results posted on

2024-08-05

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention Arm
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Overall Study
STARTED
6
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention Arm
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Arm
n=5 Participants
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Age, Customized
Age of referred child - 8 years
1 participants
n=5 Participants
Age, Customized
Age of referred child - 9 years
1 participants
n=5 Participants
Age, Customized
Age of referred child - 10 years
1 participants
n=5 Participants
Age, Customized
Age of referred child - 11 years
2 participants
n=5 Participants
Sex/Gender, Customized
Sex of referred child - male
1 participants
n=5 Participants
Sex/Gender, Customized
Sex of referred child - female
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Intervention Arm
n=5 Participants
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Parent-reported Child Behavioural Problems
1 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Intervention Arm
n=5 Participants
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Idiographic Measure of Parent-perceived Problems
3 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Intervention Arm
n=5 Participants
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Negative Parenting Practices
1 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Intervention Arm
n=5 Participants
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Parental Reflective Functioning
3 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Intervention Arm
n=5 Participants
Participants receiving the intervention whilst on a waiting list for treatment as usual 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.
Parental Wellbeing
2 participants

Adverse Events

Intervention Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Nima Moghaddam

University of Lincoln

Phone: 01522882000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place