Condition category
Mental and Behavioural Disorders
Date applied
25/07/2019
Date assigned
30/07/2019
Last edited
30/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Triple P-Positive Parenting Program is a multi-layered series of parenting interventions focused on developing positive parenting skills and techniques, including parental self-efficacy and self-management. Of particular relevance to this project is that Triple P draws heavily upon the work of Hart & Risley in the parental influence on child language and communication. Triple P strongly emphasises incidental teaching and promoting natural use of language at home. Children are more likely to develop their language ability in a safe, positive, low-conflict environment where they feel comfortable initiating conversation. However, all of the previous evaluations on Triple P measure behavioural or parenting outcomes as opposed to the impact on children’s language learning outcomes. The effect for language are unknown; hence the need for this study. As such, there is substantial value in understanding whether a programme primarily intended to improve family relationships and behaviour can have an impact on children's language acquisition, as measured through expressive language. To the researchers' knowledge, this will be one of the largest independent evaluations of Triple P in terms of the number of families included in the study, and the first study of its kind to test effects on language.

Who can participate?
Children in nursery (aged 3 to 4) from a number of areas across the UK, including Greater Manchester, Liverpool City region; Wakefield; Kirklees; Darlington; North Tyneside; South Tyneside; Northumberland; Stockton-On-Tees; Hartlepool; East Riding of Yorkshire; York and North Yorkshire; Cheshire and Chester and Blackpool.

What does the study involve?
Teachers nominate up to 12 parents of 3 or 4 years old children with language delay or other reported concerns around their behavioural, emotional and/or social development who are willing to take part in an eight-week Level 4 Group Triple P parenting programme in Spring 2020. The settings are randomly allocated to one of two groups to either receive the Triple P Intervention programme or to not receive it. The parents or carers of selected children in the intervention group settings then receive the programme for 8 weeks. Once the programme has been completed, children in all settings are assessed on their expressive language skills. Additionally, all practitioners are surveyed at the start and at the end of the study on child behaviour. The language of children in intervention group schools is compared to those in control group schools to see how much the children who took part have improved as a result of the Triple P programme.

What are the possible benefits and risks of participating?
Practitioners from settings in the intervention group will receive training and accreditation in Level 4 Group Triple P for two members of staff, and will be provided with the resources required to deliver the programme to families. Families taking part in the intervention will benefit from participation in parental group sessions and will receive one-to-one feedback. Settings in the control group will receive monetary compensation and can choose to implement the Triple P programme once the study is completed. There are no anticipated risks of participation.

Where is the study run from?
Nursery settings across the UK

When is the study starting and how long is it expected to run for?
November 2018 to December 2020

Who is funding the study?
Education Endowment Foundation (UK)

Who is the main contact?
Dr Sashka Dimova
sdimova@rand.org

Trial website

https://educationendowmentfoundation.org.uk/projects-and-evaluation/projects/level-4-group-triple-p-positive-parenting-program/

Contact information

Type

Public

Primary contact

Dr Sashka Dimova

ORCID ID

http://orcid.org/0000-0001-9587-2220

Contact details

Westbrook Centre
Milton Road
Cambridge
CB4 1YG
United Kingdom
+44 (0)1223353329
sdimova@rand.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

19024

Study information

Scientific title

Evaluation of the Level 4 Group Triple P: Positive Parenting Program®

Acronym

Triple P

Study hypothesis

This is a cluster-randomised controlled to evaluate the effectiveness of the Triple P-Positive Parenting Program. This is a multi-layered series of parenting interventions focused on developing positive parenting skills and techniques, including parental self-efficacy and self-management, through five core principles of positive parenting. During Triple P programmes, parents learn strategies to apply these principles to their family interactions. This project offers an opportunity to identify the specific effects of the intervention on language outcomes because, at present, there is no direct evidence of this relating to Triple P.

The impact evaluation is designed to investigate the following research hypotheses:
H1. Children in the intervention group, Triple P, will have higher levels of expressive language compared to children in the control (business as usual) condition.
H2. Children in the intervention group, Triple P, will have fewer behaviour problems compared to children in the control (business as usual) condition.

Ethics approval

Approval pending, RAND U.S. Human Subjects Protection Committee (HSPC) (1776 Main Street, PO Box 2138, Santa Monica, CA, 90407-2138, USA; Tel: +1 (0)866 697 5620; Email: hspcinfo@rand.org)

Study design

Two-group parallel stratified cluster-randomised control trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

https://educationendowmentfoundation.org.uk/public/files/Projects/School_Information_Sheets/Level_4_Triple_P_School_Information_Sheet.pdf

Condition

Language difficulties

Intervention

The Education Endowment Foundation (EEF) has granted funding to RAND Europe and Triple P UK to conduct a cluster-randomized trial in approximately 100-150 nursery settings in the UK assessing the effectiveness of the Level 4 Group Triple P: Positive Parenting Program ®. RAND are the EEF’s independent evaluators and are responsible for the evaluation study. Triple P are the intervention delivery team and are responsible for school recruitment and intervention delivery. Settings are expected to be recruited from the following regions: Greater Manchester, Liverpool City region; Wakefield; Kirklees; Darlington; North Tyneside; South Tyneside; Northumberland; Stockton-On-Tees; Hartlepool; East Riding of Yorkshire; York and North Yorkshire; Cheshire and Chester and Blackpool.

Triple P will be implemented by multi-disciplinary practitioners working in the early years settings who have at least an NVQ level 3 qualification or a higher qualification in health or education or early childhood education or social services. Triple P practitioners are nominated practitioners from the settings who have attended training and became accredited to deliver the programme to parents, Triple P training addresses the importance of delivery fidelity whilst also exploring permissible flexibility.
The implementation of Triple P will involve the following activities:
- Practitioners training: Two practitioners from each setting will receive training on how to deliver the programme between November 2019 and January 2020. Training will be delivered by Triple P (TP) trainers.
- Triple P Sessions: Trained practitioners will commence programme delivery in the last week of February 2020 and will include eight weekly sessions with maximum of 12 parents
Session 1: In the first group session practitioner give an introduction to parents on positive parenting, and explain why children behave as they do, and how they can stimulate positive change.
Session 2: In the second group session, parents will learn what is important for developing good relationships with children, how to teach their children new skills and behaviours and how to award good behaviour.
Session 3: During the third group session, the practitioner provides parents with more strategies that will help them manage any misbehaviour by their child. Parents will also learn to develop parenting routines to promote compliance and manage non-compliance from their children. They have an opportunity to rehearse these routines during the session.
Session 4: In this session practitioners discuss family survival tips, and how to develop planning ahead routines to promote good child behaviour in high-risk situations (e.g. shopping, learning how to take turns, fighting with siblings, getting ready for school). In the final session parents prepare for their forthcoming individual consultations.
Session 5-7: In session 5 to 8 practitioners will give one-to-one feedback to parents on their implementation routines for the high-risk situations. This will help parents refine some of their practices, if needed.
Session 8: The final session is delivered in group and the main aim is to review progress, plan for ways to maintain change in the future, and finally to close the program.

Support will be provided for practitioners in early years settings in the treatment group that will support programme adoption, implementation and sustainability. This implementation support will also focus on how to tailor the programme and processes to suit the local context. For this project, an emphasis on the aspects of Triple P related to language and communication development will be included in both training and ongoing implementation support.

Triple P programmes are manualised, meaning that practitioners follow manuals with detailed information on the programme content and principles when implementing the programme. Practitioners will receive Practitioner Kits for Group Triple P and Primary Care Triple P. These kits contain the programme manuals, copies of the parent workbooks, Presentation CD and DVD (Group Triple P), and tip sheets (Primary Care Triple P). Practitioners will also receive access to the Triple P Provider Network where they can download assessment measures and access FAQs. Practitioners will need laptops, data projectors for programme delivery. Parents will receive programme workbooks and communication tip sheets.

Early years settings in the intervention group will not receive any monetary payment. However, each will receive training and accreditation in Level 4 Group Triple P for two members of staff, and be provided with the resources required to deliver the programme to parents on the trial without any of the usual associated costs (usually approximately £3,500 per site for two people per site). Settings assigned to the control group will not take part in Level 4 Group Triple P. However, they will receive a payment of £750 that will be dependent on the setting taking part in the post-test data collection. Settings in the control group must not deliver any parenting programmes up until this point of payment.

Early years settings will be recruited by the Triple P team but will be allocated to either the intervention or control group by RAND Europe. Randomisation will be conducted using Stata in October 2019. Geographical area will be the only stratifying variable. Allocation will be revealed to settings once each has completed teacher SDQ and parent information baseline data has been collected.

The outcome analysis will be on an intention-to-treat (ITT) basis. Once randomised, early years settings and children will be analysed according to the allocation of the setting regardless of whether the early years setting complied with the intervention or not. The analysis will include all randomized schools/pupils in the groups to which they were randomly assigned, regardless of the treatment actually received, withdrawal from the intervention post-randomisation, or deviations in programme implementation. This principle is key to ensuring an unbiased analysis of intervention effects. This approach compares outcome means for the treatment and comparison groups, and subjects are analysed according to their randomised group allocation. The ITT approach is inherently conservative as it captures the averaged effect of offering the intervention. The analysis will follow the EEF’s stated preference for using multilevel modelling for clustered designs (EEF, 2018).

The effects of the intervention will be measured by an appropriate effect size such as standardized differences in means for a group dummy variable comparing pupils in treatment and control schools.

The primary outcome for this evaluation is the child’s expressive language. The rationale for having a particular focus on expressive language is two-fold. Existing research shows that challenges for lower-attainment language learners are particularly significant in the area of expressive skills and it is more sensitive to changes than receptive language (Gibson et al., 2012; Rogde et al., 2016). To measure expressive language, the researchers will use the Clinical Evaluation of Language Fundamentals for Preschool, Second Edition (CELF-P2). The general expressive language ability will be based on the level 1 core language score of the CELF-P2. This is a measure of general language ability based on the following subtests: (i) Sentence Structure; (ii) Word Structure; (iii) Expressive Vocabulary (Wiig, E. et. al, 2006). Standardised values of these three subtests will be used to define the composite expressive language score at post-trial testing. However, the researchers will also present results from each component by treatment and control groups to assess the relative importance of each component. All sub-test component measures are standardised in the UK, are age-appropriate and were selected by the evaluation and delivery team in collaboration with language experts advising the evaluation team.

The secondary outcome will be child behaviour, as this is a key outcome measure in other trials of Triple P (De Graaf et al., 2008; Sanders et al., 2003), and the working assumption is that both behaviour and expressive language should improve. The researchers propose surveying all practitioners in order to gain data on child behaviour in early years settings. As agreed with Triple P, we will use the Strength and Difficulties Questionnaire Teacher (SDQ-T) to assess child behaviour focusing on the Total Difficulties score (Goodman 1997). The SDQ –T is a well-known, short and structured instrument measuring child behaviours and can be used by parents and educators. It has 25 items each rated on three-point scale (not true, somewhat true and certainly true). The total difficulty score can range between 0 and 40 and is based on the answers of all scales (emotional problem scale; conduct problem scale; hyperactivity scale; peer problem scale) except the prosocial scale. The teacher version SDQ- T has been validated as reliable instrument for identifying behavioural problems in children aged 3-4 years, including children born in the United Kingdom (it was based on data from 16 659 families) (Croft et al., 2015; Ezpeleta et al, 2013).

The primary outcome will be measured on completion of the study in June 2020, while the secondary outcomes will be measured at pretest (baseline) in September/October 2019 and at posttest (1-2- months after completion of the 8-week intervention in June/July 2020).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Child’s expressive language measured using the level 1 core language score of the Clinical Evaluation of Language Fundamentals for Preschool, Second Edition (CELF-P2) on completion of the study in June 2020

Secondary outcome measures

Child behaviour measured using the Total Difficulties score of the Strength and Difficulties Questionnaire Teacher (SDQ-T) at pretest (baseline) in September/October 2019 and at posttest (1-2- months after completion of the 8-week intervention in June/July 2020)

Overall trial start date

30/11/2018

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Settings:
1. The setting is located in the areas for recruitment determined by the EEF and the Delivery team
2. The setting has not had Triple P or Incredible Years delivered to 3 and 4 year olds since 1 January 2018
3. The setting is not actively involved in any other EEF Home Learning Environment Trial

Children:
1. Children are 3 or 4 years old
2. The teacher is concerned about a delay in a child's language/communication development. The SDQ-T will be used to support the identification of children as appropriate for Level 4 Group Triple P (more details on the SDQ-T follow in the section on Outcome measures); OR
3. The teacher or parent is concerned about a child’s behavioural, emotional or social development; OR
4. The practitioners decide that there is an indicator of increased family vulnerability, such as: family social disadvantage, financial stress, housing insecurity, adverse life events. In many early years settings, there is a home visit by setting staff before the start of the academic year, meaning that practitioners will have a better idea about the family’s situation. Many early years staff will also have “at-the-door” conversations when children are picked up/dropped off where parents may also discuss any concerns about the child

Parents/Carers:
1. They understand and speak English
2. They have not attended either Triple P or Incredible Years parenting programmes since January 2018
3. They agree that they and their child can participate in the research and that they will attend the eight-week programme in the Spring term 2020, if allocated to the intervention group

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

The exact numbers of children and settings in the trial is not known until recruitment is completed. Triple P will seek to recruit at least 120 settings, and would expect each school to identify 10-12 participating families in each setting. It is anticipated that between 100 and 130 settings will be recruited. In total between 1100 and 1300 families will participate in the study.

Participant exclusion criteria

Parents with severe psychological illness cannot be excluded prior to initial contact with practitioner, as the practitioner may be unaware of their psychological state. However, it is suggested that their inclusion is avoided if this information later comes to light as these parents will have difficulties engaging in the programme.

Recruitment start date

01/05/2019

Recruitment end date

10/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nursery settings across the UK
-
United Kingdom

Sponsor information

Organisation

Education Endowment Foundation

Sponsor details

9th Floor
Millbank Tower
21-24 Millbank
London
SW1P 4QP
United Kingdom
+44 (0)2078021920
diotima.rapp@eefoundation.org.uk

Sponsor type

Charity

Website

https://educationendowmentfoundation.org.uk/

Funders

Funder type

Charity

Funder name

Education Endowment Foundation

Alternative name(s)

EEF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol is under review, and it will be published on the EEF webpage by September 2019. The statistical analysis plan will be completed in March 2020. Upon completion it will be published on the EEF webpage. Results of the study will first be published by RAND Europe in a report for the EEF.

IPD sharing statement
For the purpose of research, following the completion of the trial, outcome data (child’s expressive language and child’s behaviour (teacher report)) will be shared with the EEF archive's manager, at which point the EEF will act as the data controller (https://educationendowmentfoundation.org.uk/public/files/Evaluation/Data_protection/Data_protection_statement_EEF_evaluations.pdf)

Intention to publish date

02/03/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/07/2019: Trial's existence confirmed by funder.