Condition category
Mental and Behavioural Disorders
Date applied
20/10/2014
Date assigned
28/10/2014
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This project will find out the effectiveness of the Inspiring Futures parent programme provided by Malachi, currently delivered in Birmingham and Somerset in the UK. The effect of the Inspiring Futures programme was studied with a small group of parents using Interpretive Phenomenological Analysis. This indicated that parents felt supported by the Malachi workers and that their parenting skills and family relationships had improved. However, without comparing it with those who did not receive this, it is difficult to draw firm conclusions about how well the programme works. This study will assess the Inspiring Futures programme to see how well it works with the children. The main aims of the study are to find out the extent to which behaviour and emotional wellbeing differs for children whose parent(s) receive Malachi’s Inspiring Futures programme compared with similar children whose parents do not receive it.

Who can participate?
Primary schools and children’s centres across Birmingham and Somerset, UK. Participants will be the parents of children aged 7-11 years with behavioural difficulties who are referred by school/children’s centre staff.

What does the study involve?
Once a child is referred to Malachi’s service by a member of school or children’s centre staff, the initial assessments with the main caregiver will take place during two appointments: first, at a parent information session at the school hosted by Malachi (i.e., a coffee morning) to see if they are eligible and interested to take part, and second, at a home visit to collect the additional parent questionnaire data. They will be randomly allocated to either the intervention or the control group. The parents in the intervention group will receive Malachi’s Inspiring Futures programme, while the control group will receive services as usual, meaning services to which they are entitled and could potentially receive in the absence of the trial. The questionnaires for the main caregivers will be repeated for the intervention and control groups at two follow-up points. The first follow-up will take place about 14 weeks after being allocated to one of the groups. The second will take place about 32 weeks after being allocated.

What are the possible benefits and risks of participating?
The potential benefit to participating families is the reduction of the child’s emotional and behavioural problems. There are no known risks to participating families.

Where is the study run from?
The study is run from the Social Research Unit at Dartington, UK.

When is the study starting and how long is it expected to run for?
October 2014 to March 2017.

Who is funding the study?
The Big Lottery Fund (UK).

Who is the main contact?
Dr Nick Axford
naxford@dartington.org.uk

Trial website

http://dartington.org.uk/HOPE

Contact information

Type

Scientific

Primary contact

Dr Nick Axford

ORCID ID

Contact details

The Social Research Unit at Dartington
Lower Hood Barn
Dartington
TQ9 6AB
United Kingdom
+44 (0)1803 762400
naxford@dartington.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effectiveness of Malachi's Inspiring Futures parenting programme in improving behavioural and emotional outcomes in primary school children with behavioural difficulties: a randomised controlled trial

Acronym

HOPE

Study hypothesis

It is hypothesised that, when compared with children whose parent(s) have not received the programme (the control arm), children whose parent(s) have received Malachi's Inspiring Futures programme (the intervention arm) will demonstrate fewer emotional and behavioural difficulties at follow-up (as reported by parents).

It is further hypothesised that, at follow-up, parents in the intervention arm will demonstrate less maladaptive coping strategies, greater empathy in parenting, and better parenting skills than parents in the control arm (as reported by parents). In addition, it is hypothesised that there will be a positive relationship between fidelity of delivery and outcomes.

Ethics approval

Warren House Group Research Ethics committee; 20/10/2014; ref. WHG2014-002

Study design

Two-arm randomised controlled parallel-group superiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Emotional and behavioural problems

Intervention

Date of Trial Registration Application: 20/10/2014

The Inspiring Futures programme comprises two parts, one taking place after the other: (1) a group-based element for parents, and, after that ends, (2) one-to-one sessions with selected parents from the group-based element. Parents are initially invited to attend 10 to 12 (90-minute) weekly group sessions at their child's school/children's centre facilitated by a pair of Malachi workers. The group sessions run during a school term and the number of sessions depends on the length of the term, but the same content is covered across all groups. A minimum of 5 and maximum of 10 parents form each group. The course can include partners who are parents of the same child. The sessions first identify early adverse experiences of the parents and aim to raise awareness of how these past experiences can influence current behaviour. Maladaptive coping strategies are identified and parents are made aware of how these can affect parenting behaviour. A combination of child development education and solution-focused therapy is used to improve parenting skills. A key underlying mechanism related to parenting skills that Inspiring Futures attempts to address is the empathy parents feel towards their child. Malachi anticipates improved parental empathy and parenting skills, which, in turn, are considered to improve the behaviour and emotional wellbeing of the child.

The one-to-one component of the Inspiring Futures programme is delivered to a selection of parents who attended the group-based element. This takes place during the term following the group programme delivery. The following factors are considered by Malachi when determining eligibility for this further support: a) difficulty in applying the 'homework' tasks; b) examples of the parent having difficulty connecting past experiences to the present day; c) examples of parent difficulty in recognising the impact of their parenting behaviour on the child; and d) self-disclosure of an issue that suggests the parent has unresolved emotional issues. The additional support initially runs for 6 weeks (with one 60-minute session per week) and recaps sessions 2 to 7 of the Inspiring Futures programme; no new content is introduced but the one-to-one delivery is intended to allow for deeper levels of discussion with the parent. At week 6 a review takes place with the Malachi worker and the parent to decide whether further input is needed for the remainder of the school term (i.e., a further 4-6 weeks depending on term length); support does not extend beyond the end of the school term.

The control group will receive services as usual, meaning services to which they are entitled and could potentially receive in the absence of the trial. (For ethical reasons, referrers will be signposted to a standard universal children's services directory available in Birmingham or Somerset. They may - but are not required or being asked to - refer families to other services. Further, if parents in either arm of the trial request additional support after randomisation or during the course of the study the research team will signpost the family to the children's services directory.)

Added 11/12/2014:
The number of parents expected in each group is between 5 and 10; however, groups can run with a minimum of 4 parents.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The study will primarily measure changes in children's behaviour and emotional functioning from the main caregiver's perspective. These measures will be administered/collected at baseline and then at two follow-up points - the first after the parent group part of the programme (or equivalent), and the second after the one-to-one part of the programme (or equivalent).
1. Strengths and Difficulties Questionnaire - parent report (SDQ; Goodman, 1997 (Total difficulties score - this combines ratings of the child's difficulties in four domains of functioning: emotional symptoms, conduct problems, hyperactivity, and peer relationship problems).

Secondary outcome measures

Secondary assessments will include an additional measure of child behavioural conduct. In addition, measures will be used to capture changes in parent coping strategies, empathy in parenting and parenting skills, which are the key mediators through which the programme core components are theorised to impact on children's behaviour and emotional wellbeing. These measures will be administered/collected at baseline and then as two follow-up points - the first after the parent group part of the programme (or equivalent), and the second after the one-to-one part of the programme (or equivalent). Supplementary data will also be collected on family demographics (at baseline only). A service use questionnaire will establish other services that the child or family receives during the course of the study (administered at post-test only).
1. Eyberg Child Behaviour Inventory (ECBI; Eyberg, 1978)
2. Ways of Coping Questionnaire (WCQ; Folkman & Lazarus, 1988)
3. Adult-Adolescent Parenting Inventory (AAPI-2; Bavolek & Keene, 2001) Empathy subscale
4. Alabama Parenting Questionnaire (APQ; Frick, 1991)
5. Family Demographics Questionnaire (FDQ; used in Little et al., 2012 and based on the work of Herbert (1993) and previous research on predictors of socio-economic disadvantage (Dumas & Wahler, 1983; Rutter & Quinton, 1977))
6. Family Service Use Questionnaire (used in Little et al., 2012 and based on the Client Service Receipt Inventory (CSRI) (Chisholm et al., 2000; Beecham, 1995))

Overall trial start date

24/10/2014

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1.The child is aged between 7 and 11 years old at point of referral
2.The child attends a mainstream primary school or a children's centre in Birmingham or Somerset (specifically Bridgwater, Taunton or Yeovil)
3.The child scores 14 or above on the Total Difficulties score of the parent-reported SDQ
4.The parent is willing to take part in the programme and the study (information sessions will be held at the schools/children's centres and parents made aware that involvement in the Inspiring Futures programme constitutes involvement in the study)

Added 11/12/2014:
Malachi accept referrals from school years 2 to 6; therefore, some children will be 6 years old at point of referral.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

280 children to be randomised (140 intervention, 140 control)

Participant exclusion criteria

1.The parent has a mental health issue, substance abuse issue, or significant self-esteem and/or confidence issue that would seriously affect their involvement in the therapeutic group to the point that it is deemed impossible to include them
2.The family situation does not allow the parent to fully engage in the process (e.g., they have enough access to their children to impact change). For example, one of the ‘homework’ tasks in the programme involves the parent spending several minutes of quality time with the child on a daily basis, which would not be possible to implement if the parent only has weekend access to the child
3.The parent does not have a proficient understanding of English, to the level necessary to engage in the group sessions

Recruitment start date

24/10/2014

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Social Research Unit at Dartington
Dartington
TQ9 6AB
United Kingdom

Sponsor information

Organisation

The Big Lottery Fund (UK)

Sponsor details

Big Lottery Fund
1 Plough Place
London
EC4A 1DE
United Kingdom
-
general.enquiries@biglotteryfund.org.uk

Sponsor type

Charity

Website

http://www.biglotteryfund.org.uk

Funders

Funder type

Charity

Funder name

Big Lottery Fund (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes