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ViolenceNCT06099262

GenPMTO Evaluation

An observational study of Violence and Emotional Adjustment, run by The Behavioural Insights Team at 3 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This project is a multi-stage evaluation of GenPMTO (Generation Parent Management Training - Oregon Model). GenPMTO is a parenting programme which involves trained practitioners using active teaching approaches (such as group problem-solving, role-play, and video modelling) to support caregivers in using positive… Read more about this study

Who is it for?
Ages 8 to 14 years
Conditions the study is for
Violence, Emotional Adjustment, Parenting
What is being tested?
GenPMTO
How many people
36 participants
Where
3 sitesUnited Kingdom
Study dates
11 Sep 2023to Mar 2024
Phase
Observational
Are there results?
None posted in the registry

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 8 to 14 years
  • All sexes
  • Child

Study population: Caregivers of young people aged 8-14, who have been identified as being at risk of committing violent acts and/or entering into the criminal justice system.

Inclusion Criteria - Caregivers are eligible to participate in the feasibility study (including receiving GenPMTO) if they:

  • Have a child or young person (CYP) between the ages of 8-14.
  • Are the primary caregiver (i.e. spend the most time with the CYP and are available to care for them).
  • Live within one of the boroughs in which GenPMTO is being delivered (during the feasibility study).

And, if one of or more of the following is present:

  • CYPs have engaged in criminal behaviour, such as breaking the law or "offending behaviour" - for both non-violent and violent crimes.
  • CYPs have engaged in violent and challenging behaviour (including within the home, e.g. against parents and/or siblings).
  • CYPs have been reported as bullying other individual(s) in or outside of school settings.
  • CYPs have low attendance at school (<50% within the last academic year).
  • CYPs have been excluded from school within the last academic year.
  • CYPs are engaged in substance abuse/misuse (e.g. drugs, alcohol)
  • CYPs are at risk of involvement by gangs.
  • CYPs are at risk of exploitation, or negative influence, by criminal peers.
  • CYPs have a sibling(s) that has entered into the criminal justice system.

Exclusion Criteria - Caregivers will be excluded from the feasibility study it at least any of the following are present:

  • Caregiver(s) have received a parenting programme in the last two months, or are currently receiving one.
  • Caregiver(s) and CYP does not have working proficiency in English, such that participation in GenPMTO and research activities would be unfeasible.
  • Family has plans to move out of the borough within the 10-14 week delivery timeline, and thus may not be available for full delivery of GenPMTO during the feasibility study phase.
  • Severe developmental delay for caregiver or CYP which may prevent caregiver from attending GenPMTO delivery sessions, implementing GenPMTO parenting strategies, or participating in evaluation.
  • Caregiver(s) and/or CYPs are actively homicidal, suicidal or psychotic.
  • Problem sexual behaviour is the central behavioural concern for child/young person.
  • Significant child protection concern (i.e. basic needs of children are not being met by caregivers.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites, 3 recruiting
  • London Borough of Barking and Dagenham

    London

    Recruiting
  • London Borough of Brent

    London

    Recruiting
  • London Borough of Tower Hamlets

    London

    Recruiting

Other trials in United Kingdom

About this study

Official title: GenPMTO - Adaptation and Feasibility Study

This project is a multi-stage evaluation of GenPMTO (Generation Parent Management Training - Oregon Model). GenPMTO is a parenting programme which involves trained practitioners using active teaching approaches (such as group problem-solving, role-play, and video modelling) to support caregivers in using positive parenting strategies at home. The programme is designed to improve parenting practices, as well as a range of outcomes for young people, including improving academic performance, reducing school exclusions, and reducing offending and criminal behaviour. The version of the programme investigated in this project is delivered to groups of parents.

Read the detailed description

This project represents the first attempt to deliver and evaluate GenPMTO in the UK. To do so, the Ending Youth Violence Lab, at the Behavioural Insights Team, is conducting a multi-stage evaluation, involving delivering the intervention across three London boroughs, with a focus on caregivers of 8-14-year-old children and young people (CYPs), who are identified to have risk factors associated with involvement in violence.

To design this project, the Lab has collaborated with two partners. The first is ISII (Implementation Sciences International, Inc.), a research-based, non-profit organisation based in the USA, which implements the GenPMTO programme, in partnership with the programme developers. ISII also trains community practitioners in its use across the world. The second partner is Barnardo's, the UK's largest children's charity, and the delivery partner for the project.

This entry refers to the first 2 stages of the project, which will run concurrently:

Stage 1 - Adaptation and training

  • The purpose of this Stage is to prepare for initial delivery and the feasibility testing of delivery, by making any adaptations that may be necessary for the UK context and beginning practitioner training.
  • The research objectives of this Stage firstly focus on identifying whether the programme may require adaptations to fit into the UK context and identifying and justifying appropriate adaptations. Secondly, the investigators want to identify whether sufficient numbers of practitioners can be recruited and trained within the budget of the project, and to identify the optimal approach to recruitment and training of future practitioner cohorts to allow delivery at a larger scale.

Stage 2 - Feasibility study

The purpose of this Stage is to understand the feasibility of delivering GenPMTO to the caregivers of children who have been identified as being at risk of violence, through testing recruitment, retention, fidelity, etc. The investigators will also conduct further adaptation to the programme as necessary, responding to what we learn from practitioners and caregivers who have experienced the programme for the first time.

The specific research objectives here focus on:

  • Feasibility - Can Barnardo's recruit and retain caregivers of children who meet inclusion criteria and are at risk of youth violence, and deliver the programme withfidelity?
  • Acceptability - Is the GenPMTO programme seen as acceptable and valuable by caregivers and practitioners in a UK context?
  • Evaluability - Firstly, is there sufficient demand and capacity to deliver GenPMTO at a scale required for a randomised control trial? Secondly, is it feasible to collect outcome data from participants, which would support robust outcome data collection procedures during a pilot and/or efficacy trial?

This will involve delivering the programme in 3 London boroughs, and collecting a range of survey data and conducting qualitative interviews with caregivers and with practitioners to explore the above questions. The investigators will collect pre- and post-programme outcome data using a range of self-report measures, to explore the potential for future robust evaluation (rather than to assess programme impact).

Being tested
GenPMTO
Keywords
young people, youth violence, parenting programme

What participants receive

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

  • GenPMTOBehavioural

    GenPMTO is a parenting programme which involves trained practitioners using active teaching approaches (such as group problem-solving, role-play, and video modelling) to support caregivers in using positive parenting strategies at home. The programme is designed to improve parenting practices, as well as a range of outcomes for young people, including improving academic performance, reducing school exclusions, and reducing offending and criminal behaviour. The version of the programme investigated in this project is delivered to groups of parents.

Study groups in NCT06099262
Study groupRoleWhat they receive
Tower Hamlets 1Delivering the GenPMTO programme to one group of caregivers within the Tower Hamlets borough.
Receives: Behavioral: GenPMTO
Tower Hamlets 2Delivering the GenPMTO programme to a second group of caregivers within the Tower Hamlets borough.
Receives: Behavioral: GenPMTO
Brent 1Delivering the GenPMTO programme to one group of caregivers within the Brent borough.
Receives: Behavioral: GenPMTO
Brent 2Delivering the GenPMTO programme to a second group of caregivers within the Brent borough.
Receives: Behavioral: GenPMTO
Barking & Dagenham 1Delivering the GenPMTO programme to one group of caregivers within the Barking \& Dagenham borough.
Receives: Behavioral: GenPMTO
Barking & Dagenham 2Delivering the GenPMTO programme to a second group of caregivers within the Barking \& Dagenham borough.
Receives: Behavioral: GenPMTO

What is being measured

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

  1. Proportion of practitioners recruited to deliver GenPMTO

    This will involve calculating, as a percentage, the number of recruited practitioners, compared to the target.

    Measured: Prior to delivery of the intervention

  2. Proportion of practitioners enrolled in training to deliver GenPMTO

    This will involve calculating, as a percentage, the number of practitioners enrolled in training, compared to the target.

    Measured: Throughout delivery of the intervention - approximately 5 months

  3. Number of referrals received for caregivers to receive GenPMTO

    This will involve identifying the total count of referrals received during the feasibility study, as well the mean and standard deviation of monthly referral totals across the feasibility study.

    Measured: Prior to delivery of the intervention

  4. Proportion of referred caregivers deemed eligible for GenPMTO

    This will involve calculating, as a percentage, the number of caregivers deemed eligible for GenPMTO, compared to to the total number of referred caregivers.

    Measured: Prior to delivery of the intervention

  5. Proportion of eligible caregivers who are offered GenPMTO who accept this offer (take-up of services)

    This will involve calculating, as a percentage, the number of caregivers who consent to take part in the feasibility study, compared to to the total number of caregivers who are considered eligible to receive and are offered the programme.

    Measured: Prior to delivery of the intervention

  6. Retention / drop-out rates of caregivers receiving GenPMTO

    This will involve calculating, as a percentage, the number of caregivers who complete a program, compared to the total number of caregivers who consent to receiving GenPMTO

    Measured: Throughout delivery of the intervention - approximately 5 months

  7. Retention / drop-out rates of practitioners delivering GenPMTO

    This will involve calculating, as a percentage, the number of practitioners who have completed relevant training and are able to deliver GenPMTO, compared to the total number of practitioners who were enrolled in training.

    Measured: Throughout delivery of the intervention - approximately 5 months

  8. Attendance rate at GenPMTO sessions

    This will involve calculating, as a percentage, the number of caregivers who attended each GenPMTO session, compared to the number of caregivers who were expected (i.e. based on caregiver take-up/enrollment) to attend these sessions, as well the mean and standard deviation across the feasibility study.

    Measured: Throughout delivery of the intervention - approximately 5 months

  9. Caregivers' perception of the quality of the content and delivery

    This will involve calculating the mean and standard deviation of scores, based on a short feedback survey.

    Measured: Within 1 month after the end of the intervention

  10. Programme dosage data

    This will involve calculating the mean percentage of actual content delivered in GenPMTO sessions to a cohort of caregivers, compared to the amount of planned content to be delivered.

    Measured: Throughout delivery of the intervention - approximately 5 months

  11. Ratings of practitioner fidelity

    This will involve calculating the mean of practitioners' fidelity scores whilst delivering a full GenPMTO programme. Fidelity is measured using the Fidelity of Implementation (FIMP) Rating System system (expert assessment of videotaped sessions). Each session is assessed on a 9 point scale (1 referring to 'needs work', and 9 referring to 'good work').

    Measured: Throughout delivery of the intervention - approximately 5 months

  12. Parenting approach

    Parenting Practices Interview (self-reported measure)

    This is a 64 item measure, with responses measured on a 1-7 Likert scale. Total scores range from 64 to 448, with higher scores indicating improved parenting practices.

    Measured: Within 1 month after the end of the intervention

  13. Parental self-efficacy

    Parental Locus of Control-Short Form Revised (self-report)

    This is a 24 item measure, with responses measured on a 1-5 Likert scale. Total scores range from 24 to 120, with higher scores indicating greater parental self-efficacy.

    Measured: Within 1 month after the end of the intervention

  14. Behavioural problems

    Strengths and Difficulties Questionnaire (parent report of child)

    The overall (five-subscale) SDQ score ranges from 0 to 50, with a higher score indicating abnormal behaviours. The Total Difficulties score ranges from 0 to 40. The externalising score ranges from 0 to 20 and is the sum of the conduct and hyperactivity scales. The internalising score ranges from 0 to 20 and is the sum of the emotional and peer problems scales. Higher scores indicate abnormal behaviours.

    Measured: Within 1 month after the end of the intervention

  15. Behavioural problems

    Eyberg Child Behaviour Inventory (parent report of child)

    7-point Likert scale, from 1 ('Never Occurs') to 7 ('Always Occurs') and a Yes/No Problem scale. Individual Intensity Score items are summed up, with resultant scores ranging from 36 to 252. For each item, the parents' response regarding whether the behaviour is a problem for them ('Yes' = 1 , 'No' = 0) is also summed to create the Problem Score, ranging from 0 to 36.

    Measured: Within 1 month after the end of the intervention

  16. Offending behaviour - Variety

    Young people are asked to report on offending behaviours they have participated in.

    Variety of delinquency score:

    Sum the number of items the respondent answers 'yes' to:

    Yes = 1 No = 0

    Produces a score that ranges from 0-19, where a higher score indicates a higher variety of delinquency.

    Measured: Within 1 month after the end of the intervention

  17. Offending behaviour - Volume

    Self-reported delinquency scale (child self-report measure)

    Young people are asked to report on offending behaviours they have participated in.

    Volume of delinquency score:

    Summing the point values when respondents report a number of times. Point values are assigned as follows:

    Once = 1 Twice = 2 3 times = 3 4 times = 4 5 times = 5 Between 6 and 10 times = 6 More than 10 times = 11

    Produces a score that ranges from 0 to 11 for each delinquent behaviour, where a higher score indicates a higher volume of delinquency

    Measured: Within 1 month after the end of the intervention

  18. Victimisation

    Victimisation sub-scale of the Problem Behaviour Frequency Scale (child self-report measure)

    Produces a score ranging from 6-36 achieved by summing scores of the two subscales, where a higher score indicates a higher frequency of problem behaviours

    Measured: Within 1 month after the end of the intervention

Timeline

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

  1. First posted25 Oct 2023
  2. Study start11 Sep 2023
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06099262
Sponsor's protocol ID
2023056
Status last verified
Oct 2023
First submitted
26 Sep 2023
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Violence and Emotional Adjustment, run by The Behavioural Insights Team at 3 sites 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?

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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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

Contact Elizabeth Brailsford (+44 7732 800589, elizabeth.brailsford@barnardos.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of practitioners recruited to deliver GenPMTO (time frame: Prior to delivery of the intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Oct 2023.

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