Clinical trial NCT06099262: GenPMTO Evaluation
Official title: GenPMTO - Adaptation and Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Violence
Emotional Adjustment
Parenting
Parent-Child Relations
Keywords: young people
youth violence
parenting programme
Lead sponsor: The Behavioural Insights Team
Sponsor class: OTHER
Collaborators: name: Implementation Sciences International, Inc
name: Barnardos
First posted: 2023-10-25
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of practitioners recruited to deliver GenPMTO
timeFrame: Prior to delivery of the intervention
measure: Proportion of practitioners enrolled in training to deliver GenPMTO
timeFrame: Throughout delivery of the intervention - approximately 5 months
measure: Number of referrals received for caregivers to receive GenPMTO
timeFrame: Prior to delivery of the intervention
measure: Proportion of referred caregivers deemed eligible for GenPMTO
timeFrame: Prior to delivery of the intervention
measure: Proportion of eligible caregivers who are offered GenPMTO who accept this offer (take-up of services)
timeFrame: Prior to delivery of the intervention
measure: Retention / drop-out rates of caregivers receiving GenPMTO
timeFrame: Throughout delivery of the intervention - approximately 5 months
measure: Retention / drop-out rates of practitioners delivering GenPMTO
timeFrame: Throughout delivery of the intervention - approximately 5 months
measure: Attendance rate at GenPMTO sessions
timeFrame: Throughout delivery of the intervention - approximately 5 months
measure: Caregivers' perception of the quality of the content and delivery
timeFrame: Within 1 month after the end of the intervention
measure: Programme dosage data
timeFrame: Throughout delivery of the intervention - approximately 5 months
measure: Ratings of practitioner fidelity
timeFrame: Throughout delivery of the intervention - approximately 5 months
measure: Parenting approach
timeFrame: Within 1 month after the end of the intervention
measure: Parental self-efficacy
timeFrame: Within 1 month after the end of the intervention
measure: Behavioural problems
timeFrame: Within 1 month after the end of the intervention
measure: Behavioural problems
timeFrame: Within 1 month after the end of the intervention
measure: Offending behaviour - Variety
timeFrame: Within 1 month after the end of the intervention
measure: Offending behaviour - Volume
timeFrame: Within 1 month after the end of the intervention
measure: Victimisation
timeFrame: Within 1 month after the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Borough of Barking and Dagenham
city: London
country: United Kingdom
facility: London Borough of Brent
city: London
country: United Kingdom
facility: London Borough of Tower Hamlets
Study officials:
References: