Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
When a child has a behaviour problem, the first treatment that is usually tried is a parenting programme or sessions on child behaviour management techniques. These work for many people but they don’t work for everyone. Some children have what are called ‘hard to treat behaviour problems’. Currently, there is little research looking into how best to help these children. Some researchers think a therapy called ‘Child Psychotherapy’ might help. This is already available in the NHS, but the therapy itself takes a long time. This study is looking at a brief version of this Child Psychotherapy treatment so that children and their parents/carers don’t have to go to so many sessions. The aim of these study is to find out whether it is feasible to carry out a larger study investigating whether this brief version of Child Psychotherapy is better than the ‘usual treatment’ offered.

Who can participate?
Children aged 5-11 years old, and their main caregiver, who have been referred to CAMHS with a behaviour problem.

What does the study involve?
Participants are randomly allocated to one of two groups. The children (and their caregivers) in the first group take part in 12 weekly 50 minute therapy sessions. The children (and their caregivers) in the second group continue to receive usual care for the duration of the study. At the end of the study, the amount of participants who agreed to take part and those who completed the study are recorded.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The study is run from the Clinical Trials Unit at the University of Leeds (UK)

When is the study starting and how long is it expected to run for?
March 2016 to September 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Ms Liz Graham

Trial website

Contact information



Primary contact

Dr Sadie Reed


Contact details

Clinical Trials Research Unit (CTRU)
Leeds Institute of Clinical Trials Research
University of Leeds
United Kingdom
+44 (0)113 3439421

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Trial on Improving Inter-Generational Attachment for Children Undergoing Behaviour Problems



Study hypothesis

The aim of this study is to investigate the practicability of implementing a confirmatory, randomised controlled trial (RCT) comparing Child Psychotherapy (CP) to Treatment as Usual (TaU), as a second-line intervention for children aged 5-11 with treatment resistant conduct disorders and inter-generational attachment difficulties and for their primary carers.

Ethics approval

Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 17/03/2016, ref: 16/YH/0055

Study design

Interventional; Design type: Treatment, Psychological & Behavioural, Complex Intervention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


Specialty: Children, Primary sub-specialty: Neurosciences; UKCRC code/ Disease: Mental Health/ Behavioural syndromes associated with physiological disturbances and physical factors


Participants will be randomised on a 1:1 basis to receive either Manualised Child Psychotherapy or Treatment as Usual.

Child Psychotherapy: Both the primary carer and child will each attend 12, weekly 50 minute therapy sessions, as prescribed by the TIGA-CUB Child Psychotherapy manual.

Treatment as Usual: Participants receive the usual care offered by local CAMHS teams. This treatment is likely to be highly diverse and may involve group and/or individual and/or primary carer and/or family based work, delivered by a range of practitioners from a variety of professional backgrounds and theoretical orientations.

Participants will be contacted for follow-up at 4 months post-randomisation.

Intervention type



Drug names

Primary outcome measure

1. Recruitment rate is measured by recording the proportion of dyads who consented to participate at the study end
2. Attrition rate is measured by recording the proportion of dyads completing the study out of those randomised to follow-up at the study end
3. Adherence is measured by recording the proportion of dyads randomised to the intervention arm successfully completing the required number of therapy sessions specified in the manual (or fewer, as determined by the CAPT) at the study end

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Children aged 5-11 years old at baseline
2. Presenting to CAMHS, or re-referred within CAMHS, with a clinical conduct disorder (≥4 on Strengths and Difficulties (SDQ) conduct sub-scale)
3. Child’s current primary carer* has been offered a first line group or individual parenting programme or other structured parenting intervention in primary care or within CAMHS, and has attended at least one session, but the child’s conduct disorder persists and the child has been referred to CAMHS or re-referred within CAMHS for further treatment.

*The term ‘primary carer’ denotes the adult most involved in parenting the child.

Participant type


Age group




Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Children with a clinical diagnosis of Autistic Spectrum Disorder (ASD), including Asperger’s
2. Children with a clinical diagnosis of severe Learning Difficulties (LD)
3. Children medicated for Attention Deficit Hyperactivity Disorder (ADHD), unless they have been on a stable medication dose for 3 months or more (children with un-medicated ADHD are eligible if other inclusion criteria met)
4. Looked After Children (LAC) (including adopted children):
4.1. who are not in kinship foster care or special guardianship, or
4.2. who are not in kinship foster care or special guardianship which is stable (> 6 months)
5. Children under/at risk of Safeguarding or Court procedures
6. Children whose primary carer has severe mental health difficulties, determined by usual CAMHS procedures using clinical judgement (baseline GHQ-12 will be monitored for primary carers with severe mental health difficulties not identified by CAMHS)
7. Sibling has been randomised to the TIGA-CUB trial (as CP involving two CAPTs, which would be required for two children, may not be available in some of the services involved in the trial)
8. Primary carer is actively receiving a parenting programme within CAMHS for the child’s sibling
9. Primary carer lacks capacity to comply with trial requirements, e.g. as a result of a LD, due to research burden or due to insufficient proficiency in English
10. Primary carer has severe adverse parental functioning e.g. alcohol dependence (≥20 on Alcohol-Use Disorders Identification Test) or drug dependence (≥3 on Drug Abuse Screening Test), determined by the study Researcher on initial screening visit

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Clinical Trials Research Unit Leeds Institute of Clinical Trials Research
United Kingdom

Sponsor information


Leeds and York Partnership NHS Foundation Trust

Sponsor details

First Floor
South Wing
St Mary’s House
St Mary’s Road
LS15 8ZB
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are not expected to be made available as participants have not consented for their data to be used in further research.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2017 protocol in:

Publication citations

Additional files

Editorial Notes

19/10/2017: Publication and dissemination plan, IPD sharing statement and publication reference added. 18/10/2017: The overall trial end date was changed from 15/12/2017 to 01/09/2017. 04/10/2016: The study contact has been changed from Ms Liz Graham to Dr Sadie Reed.