Mental HealthRIGHTNCT04187911
Relationships in Good Hands - Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy
A study testing Dyadic Developmental Psychotherapy (DDP) and Services as Usual (SAU) in people with Mental Health and Psychiatric Problems, run by University of Glasgow at 16 sites in United Kingdom.
Trial summary
The research question is: Can the research recommend better ways for social care and health services to work work together to help adoptive and foster families? Can a therapy called DDP improve the mental health of 5-12 year old fostered or adopted children? Is DDP worth the commitment families need to give to it … Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Mental Health, Psychiatric Problems, Child Neglect
- What is being tested?
- Dyadic Developmental Psychotherapy (DDP) and Services as Usual (SAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- 1 May 2020to 31 Jul 2025
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Adoptive or permanent foster parents with children aged 5-12 years with symptoms of MAPP or co-occurring mental health conditions and non-psychotherapeutic treatments
Who cannot join
- Families, otherwise eligible, deemed by therapists as not ready for DDP (usually where therapists have concerns about the ability of carers/parents to create a safe/ nurturing enough environment within which DDP can operate)
- Children currently having another psychotherapy
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites, 14 recruiting
- Recruiting
Vale Valleys and Cardiff Adoption Collaborative
Barry
Angela Harris, apharris@valeofglamorgan.gov.uk
Claire Blackburn, cblackburn@valeofglamorgan.gov.uk
- Recruiting
Bedford Borough Council
Bedford
Claire Grady, claire.grady@bedford.gov.uk
- Recruiting
Birmingham Children's Trust
Birmingham
Jane Francis, jane.francis@birminghamchildrenstrust.co.uk
Lee Vince, lee.vince@birminghamchildrenstrust.co.uk
- Active, not recruiting
Bradford District Care Foundation Trust
Bradford
- Recruiting
One Adoption South Yorkshire
Doncaster
Ellen Holliday, ellen.holliday@doncaster.gov.uk
- Recruiting
Blaenau Gwent County Borough Council
Ebbw Vale
Becky Jones, becky.jones@blaenau-gwent.gov.uk
Luiza Bivolaru, luiza.bivolaru@blaenau-gwent.gov.uk
- Recruiting
Lanarkshire
Lanark, Scotland
Duncan Clark, duncan.clark@lanarkshire.scot.nhs.uk
- Recruiting
South London and Maudsley NHS Foundation Trust
London
Hannah Tobin, hannah.tobin@slam.nhs.uk
Rani Samuel, rani.samuel@slam.nhs.uk
- Recruiting
Norfolk and Suffolk NHS Foundation Trust
Norwich
Charlotte Granger, charlotte.granger@nsft.nhs.uk
- Recruiting
Norfolk County Council
Norwich
Rebecca Howard, rebecca.howard@norfolk.gov.uk
- Recruiting
Nottingham City Council
Nottingham
Matthew Jenkins, matthew.jenkins@nottinghamcity.gov.uk
Pallab Majumder, pallab.majumder@nottshc.nhs.uk
- Recruiting
Nottinghamshire County Council (Adoption East Midlands)
Nottingham
Jane Bolan, jane.bolan@adoptioneastmidlands.nottscc.gov.uk
Victoria Pike, victoria.pike@adoptioneastmidlands.nottscc.gov.uk
- Recruiting
Oxfordshire
Oxford
Mat Lister, mathew.lister@oxfordhealth.nhs.uk
Mina Fazel
- Recruiting
Central Bedfordshire Council
Shefford
Nickie Phillips, nickie.phillips@centralbedfordshire.gov.uk
Anne Devine, anne.devine@centralbedfordshire.gov.uk
- Recruiting
Hertfordshire County Council
Stevenage
Claire Frampton, claire.frampton@hertfordshire.gov.uk
Sarah Wicks, sarah.wicks@hertfordshire.gov.uk
- Withdrawn
Adoption@Heart
Wolverhampton
About this study
Official title: Relationships in Good Hands Trial: Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy for Abused and Neglected Young Children With Maltreatment-associated Problems and Their Parents
The research question is: Can the research recommend better ways for social care and health services to work work together to help adoptive and foster families? Can a therapy called DDP improve the mental health of 5-12 year old fostered or adopted children? Is DDP worth the commitment families need to give to it - and the extra cost to the services that deliver it? More than half of adopted or fostered children in the UK have mental health problems including ADHD (i.e. hyperactivity, impulsive behaviour and poor concentration), antisocial behaviour and problems with relationships. Abused and neglected children are more likely than others to have problems in school, become homeless, get involved in crime and even die young (e.g. from suicide), yet there are no fully tested treatments for such complex mental health problems. This is a huge problem because early treatment could greatly improve children's life chances - and reduce strain on health and social care budgets.
There is a Dyadic Developmental Psychotherapy (DDP) a parent-child therapy that takes around 20 sessions and focusses on "Playfulness, Acceptance, Curiosity and Empathy". There is not yet available really good evidence for or against it: many UK therapists like DDP, but it is a big commitment for families: once a week for about six months children will need time off school, the parents will need time off work - and this can be hard to explain to school friends, colleagues and bosses. Research team doesn't just need to know if DDP improves children's mental health - they also need to know if the commitment needed is worth it for families and whether the costs to services outweigh the benefits.
Read more
In PHASE 1 the research team will find out whether DDP can work smoothly in the three different settings where it is usually delivered: the NHS, Social Care and Private Practice. Many abused children need other medical and psychiatric support so, the research will assess whether children can get any additional assessments or referrals they may need .
In PHASE 2, the research team plans to find out if it is practically possible to run a high quality trial of DDP. This phase will involve 60 families to find out if they are happy to take part (whether offered DDP or usual services). If all goes to plan, these 60 families will contribute to the final results, along with the 180 families involved in the next PHASE 3 when the research team will test whether DDP is better than usual services and, if it is, whether the improvements in child mental health outweigh the costs.
What impact will the research have? This study will make recommendations about how services should work together to help abused and neglected children and their families. If the researcher team finds that DDP is worth the time and money, it could improve the mental health of abused and neglected children across the world.
Read the detailed description
Abused and neglected children are at extremely high lifetime risk of psychiatric disorder placing a huge burden on health/social care services and society. Virtually all 92,000 children adopted or fostered in the UK have suffered abuse or neglect, therefore risking profoundly negative outcomes in important areas of development including problematic social relationships, academic underachievement and involvement in crime. These disadvantages can lead to negative spirals of poor health and social inequality. Early intervention can greatly improve their life chances, yet there are no adequate psychosocial treatment strategies or care pathways to address the needs of maltreated children. Psychiatric problems of maltreated children are characterised by complexity. They have experienced extreme environmental risk and are at higher genetic risk than peers. Many also struggle to develop and maintain healthy family relationships. Neurodevelopmental disorders such as Attention Deficit/Hyperactivity Disorder (ADHD) and Autism often co-exist with disorders arising from the abuse and neglect such as Conduct Disorder, Attachment Disorders and Post Traumatic Stress Disorder (PTSD) with devastating consequences for lifelong mental health and development. To reflect this complexity, research team uses the overarching term Maltreatment-Associated Psychiatric Problems (MAPP).
The proposed project is a three-phase development and exploratory trial of Clinical and cost-effectiveness of Dyadic Developmental Psychotherapy (DDP) for abused and neglected children with MAPP and their parents compared to Service as Usual (SAU). The data will be collected in 3 phase trial, through a mixture of qualitative and quantitative methods.
Phase 1 Months 1-9 (9 months)
The first phase will focus on intervention and context optimisation that will take place in 3 sites, each representing one of the UK DDP service delivery contexts: NHS, Social Services and Private Practice. The research questions will be addressed through 24-36 qualitative interviews, and focus groups as well as review meetings at each site, with practitioners and managers involved in delivery of DDP and SAU. The research team will require input from the services practitioners and managers but also Young Peoples' Advisory Groups (YPAG) and Patient, Public, Commissioner Involvement (PPCI) groups.
Phase 2 Months 10-26 (17 months)
To examine the research questions, and minimise bias, the proposed design is a single-blind randomised controlled trial, with two-groups. The aim of this phase will be to respond to research questions such as what are recruitment and retention rates over 6 months; are the trial assessments and interventions acceptable to parents and professionals; are there functional data collection systems enabling future cost effectiveness analysis. This phase will also assess fidelity to the DDP model and whether the care pathways to CAMHS are maintained throughout.
The research team will aim to recruit around 60 families. The potential participants will be identified and approached by their usual service provider. The usual service research administrator will ensure eligible families receive the study participant information leaflet to learn about the study. Once the interest of the family to take part in the trial is confirmed, a research nurse will contact interested families 24 hours later, to discuss the study further and seek consent. Families that confirm their willingness to participate will be invited for two study visits one at baseline, shortly after joining study and second visit after 12 months.
On completion of the baseline data collection, consenting families will be individually randomised 1:1 to DDP or SAU, stratified by site. Individuals who consent to take part will have an equal chance of being randomised to either group. One group will be included in the DDP intervention. The second group will take part in the Services as Usual. The research assistant with responsibility for collecting the data will not know which group participants have been allocated to until the end of the study. The intervention will be delivered by the participant's usual health care team.
Beside the randomised controlled trial, the data will be collected through qualitative research activities to explore social context supporting/hindering child mental health, optimising the contexts of, and processes for, DDP delivery.
Process evaluation
Qualitative work in phase 2 has three main aims:
- To keep abreast of issues and themes uncovered in Phase 1 in the three feasibility trial sites, to ensure ongoing compliance with guidelines for safe DDP delivery and to explore the social context supporting/hindering child mental health in each site including drivers and barriers to optimal DDP/SAU delivery. 6-10 interviews/focus groups will be conducted with therapists, managers and families across the sites.
- To explore the same topics from Phase 1 in the seven putative Phase 3 trial sites - optimising the contexts of, and processes for, DDP delivery in those sites and examining compliance with the DDP delivery guidelines established in Phase 1. 18-26 interviews/focus groups will be conducted across the sites.
- To allow selection of 2-4 additional sites for Phase 3. The number of additional sites required for Phase 3 will be decided based on Phase 2 conversion rates from eligible to consented families and on statistical power considerations based on the standard deviation, in Phase 2, of our principle outcome measure.
Phase 2 will also adopt case study methodology to focus more specifically on the impact of DDP and SAU. The research team will learn through a more in-depth investigation (individual interviews) about participant experience of DDP/SAU and of journeys through service landscapes from the perspectives of the family, therapists, and other key stakeholders involved in the treatment of and care pathways. A small selection of families (2-3 families) will be invited to take part.
Phase 3 Months 27-53 (27 month RCT; (6 month analysis/write-up).
The third phase will continue as a single-blind individually randomised controlled superiority definitive trial. The aim of this phase will be to examine the clinical and cost-effectiveness of DDP for improving child mental health, compared to SAU. The principle outcome will be child's mental health at 12 months post randomisation. The research team will aim to recruit additional 180 families, including phase 2. The study population, interventions, randomisation, data collection, measures, model fidelity and procedures will be as described for Phase 2 unless findings from the process evaluation suggest modifications.
Qualitative evaluation (process evaluation) will continue at the same intensity as Phase 2, with a similar number of interviews/focus groups (24-36 across all sites), to explore delivery drivers/barriers in each service context. The case studies will continue, involving a further 10-12 interviews, to track development over time. The PPCI group and YPAG will have a crucial role in the Process Evaluation, during this phase, in reviewing the qualitative findings with the Process Evaluation Team (PET) and considering how these findings pragmatically feed into future service delivery. Whether or not DDP is eventually found to be cost-effective over services as usual, the process evaluation will yield important information about how mental health services can be safely delivered for maltreated children in different services contexts (i.e. NHS CAMHS, Social Care and Private Practice).
- Conditions
- Mental Health, Psychiatric Problems, Child Neglect, Maltreatment, Adoption, Child Behaviour Problem
- Being tested
- Dyadic Developmental Psychotherapy (DDP), Services as Usual (SAU)
- Keywords
- Feasibility, Randomised, Optimisation, Partnerships, Cost effectiveness, Clinical effectiveness
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic Developmental Psychotherapy (DDP)Behavioural
DDP involves approximately twenty 1 hour sessions (usually over 6-9 months) with the adoptive parent/foster carer and child, facilitated by a specifically trained therapist. The role of the therapist during sessions is to maintain an attuned relationship with both child and parent - modelling and encouraging development of a similarly attuned relationship between the child and parent. Therapists are trained to use Playfulness, Acceptance, Curiosity and Empathy (PACE). Our research suggests that key mechanisms of action in DDP might include the active participation of the parents and increased carer empathy and emotional warmth for the child. DDP experts believe this helps build parental capacity for attuned dialogue with the child, co-creation of the meanings underlying child behaviour, and co-regulation of experienced emotions aiming to address four main problem areas: 1. child emotional regulation 2. parental stress 3. the parent-child relationship 4. child mental health.
Services as Usual (SAU)Behavioural
SAU tends to be case-dependent with therapists and social workers attempting to respond to the sometimes changeable needs of the family as needs arise. At the time of our UK mapping and modelling work, these services were usually CAMHS based. This may have changed, at least for adoptive families, with the advent of the Adoption Support Fund, which, since May 2015, has allowed local authorities / adoption agencies to apply for funding for "essential therapeutic services". A wide range of interventions, many with a scant evidence base, have been purchased - sometimes from private practitioners - since 2015. In addition, relevant NICE guidelines, particularly those on Looked After and Accommodated Children, Attachment and Child Abuse and Neglect, have been published or updated.Our detailed qualitative and quantitative process evaluation throughout all study Phases will be crucial to carefully characterise SAU in all study sites.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Dyadic Developmental Psychotherapy (DDP) | Experimental | DDP involves approximately twenty 1 hour sessions (usually over 6-9 months) with the adoptive parent/foster carer and child, facilitated by a specifically trained therapist. DDP aims to treat trauma-related problems and Attachment Disorders over about 20 1-hour sessions using the core communication techniques of Playfulness, Acceptance, Curiosity and Empathy (PACE) Receives: Behavioral: Dyadic Developmental Psychotherapy (DDP) |
| Control - Services as Usual (SAU) | Active comparator | SAU tends to be case-dependent with therapists and social workers attempting to respond to the sometimes changeable needs of the family as needs arise. Receives: Behavioral: Services as Usual (SAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA)
The Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA) is the only measure of Attachment Disorder symptoms that is well validated against clinician diagnosis in middle childhood. Ii is a diagnostic measure that has algorithms compliant with DSM 5 for Reactive Attachment Disorder (RAD) and Disinhibited Social Engagement Disorder (DSED), and it can also be used as a continuous measure (33-items; scoring range 0-66). Previous research suggests a standard deviation of 10.4 for the RADA. Applying the same assumption as for SDQ (correlation between baseline and follow-up of 0.4, correlation within clusters of 0.03, cluster size of 10, retention rate of 0.72), there will be 90% power to detect a difference in RADA of at least 7.25 with a sample size of 190. Typically developing children usually have very low or zero scores on measures for Attachment Disorders so would consider such a change in RADA to be clinically significant.
Measured: 12 months from baseline
Strengths and Difficulties Questionnaire (SDQ)
Strengths and Difficulties Questionnaire (SDQ) has good sensitivity to change in RCTs. Candidate measures are included for the four problem areas in our logic model: child emotion regulation, parental stress, parent-child relationship functioning and child mental health. The research team estimates that 190 families will be required to determine clinical- and cost effectiveness based on findings from an ongoing trial of maltreated pre-school children, information from clinics using the SDQ to evaluate DDP and SDQ population norms. This aims for 90% power, assumes a clinical difference in SDQ of 4 points, a baseline and 1-year follow-up correlation in SDQ of 0.4, a standard deviation in SDQ of 5.8, an intra-cluster correlation of 0.03 (between families who see the same therapist) and a retention rate of 72%.
Measured: 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 May 2020
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 2 Months 10-26 (17 months) To examine the research questions, and minimise bias, we propose to use a single-blind randomised controlled design, with two-groups. The aim of this phase will be to respond to what recruitment and retention rates are over 6 months and trial assessments and intervention acceptability. We will aim to recruit around 60 families. Consenting families will be individually randomised 1:1 to DDP or SAU, stratified by site. Individuals who consent to take part will have an equal chance of being randomised to either group. Phase 3 (27 months RCT) The third phase will continue as a single-blind individually randomised control superiority definitive trial and will examine clinical and cost-effectiveness of DDP for improving child mental health, compared to SAU. We will aim to recruit additional 180 families. All the procedures will be same as during Phase 2 as explained in details above.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Oxford, University of Nottingham
- Responsible party
- Principal investigator, Helen Minnis, University of Glasgow
- Investigators
- Helen Minnis, Professor, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187911
- Sponsor's protocol ID
- NIHR127801
- Other IDs
- L19083
- Acronym
- RIGHT
- Status last verified
- May 2024
- First submitted
- 3 Dec 2019
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vasileva M, Petermann F. Attachment, Development, and Mental Health in Abused and Neglected Preschool Children in Foster Care: A Meta-Analysis. Trauma Violence Abuse. 2018 Oct;19(4):443-458. doi: 10.1177/1524838016669503. Epub 2016 Sep 22.
PubMed 27663993Harkess-Murphy E, Macdonald J, Ramsay J. Self-harm and psychosocial characteristics of looked after and looked after and accommodated young people. Psychol Health Med. 2013;18(3):289-99. doi: 10.1080/13548506.2012.712706. Epub 2012 Aug 6.
PubMed 22867514Font SA, Maguire-Jack K. Pathways from childhood abuse and other adversities to adult health risks: The role of adult socioeconomic conditions. Child Abuse Negl. 2016 Jan;51:390-9. doi: 10.1016/j.chiabu.2015.05.013. Epub 2015 Jun 6.
PubMed 26059537Duncan AE, Auslander WF, Bucholz KK, Hudson DL, Stein RI, White NH. Relationship between abuse and neglect in childhood and diabetes in adulthood: differential effects by sex, national longitudinal study of adolescent health. Prev Chronic Dis. 2015 May 7;12:E70. doi: 10.5888/pcd12.140434.
PubMed 25950577Rivenbark JG, Odgers CL, Caspi A, Harrington H, Hogan S, Houts RM, Poulton R, Moffitt TE. The high societal costs of childhood conduct problems: evidence from administrative records up to age 38 in a longitudinal birth cohort. J Child Psychol Psychiatry. 2018 Jun;59(6):703-710. doi: 10.1111/jcpp.12850. Epub 2017 Dec 2.
PubMed 29197100Burt SA, Hyde LW, Frick PJ, Jaffee SR, Shaw DS, Tremblay R. Commentary: Childhood conduct problems are a public health crisis and require resources: a commentary on Rivenbark et al. (). J Child Psychol Psychiatry. 2018 Jun;59(6):711-713. doi: 10.1111/jcpp.12930.
PubMed 29808490Denham SA, Bassett HH, Sirotkin YS, Brown C, Morris CS. "No-o-o-o Peeking": Preschoolers' Executive Control, Social Competence, and Classroom Adjustment. J Res Child Educ. 2015 Apr 1;29(2):212-225. doi: 10.1080/02568543.2015.1008659.
PubMed 26166925Li D, Chng GS, Chu CM. Comparing Long-Term Placement Outcomes of Residential and Family Foster Care: A Meta-Analysis. Trauma Violence Abuse. 2019 Dec;20(5):653-664. doi: 10.1177/1524838017726427. Epub 2017 Aug 31.
PubMed 29333987Luchenski S, Maguire N, Aldridge RW, Hayward A, Story A, Perri P, Withers J, Clint S, Fitzpatrick S, Hewett N. What works in inclusion health: overview of effective interventions for marginalised and excluded populations. Lancet. 2018 Jan 20;391(10117):266-280. doi: 10.1016/S0140-6736(17)31959-1. Epub 2017 Nov 12.
PubMed 29137868Dozier M, Peloso E, Lewis E, Laurenceau JP, Levine S. Effects of an attachment-based intervention on the cortisol production of infants and toddlers in foster care. Dev Psychopathol. 2008 Summer;20(3):845-59. doi: 10.1017/S0954579408000400.
PubMed 18606034Nelson CA, Fox NA, Zeanah CH. Developmental Psychopathology 2016:1-37.
Wright B, Barry M, Hughes E, et al. Health Technology Assessment 2015;19 (52) ISSN 1366- 5278. https://www.ncbi.nlm.nih.gov/books/NBK305116/
National Collaborating Centre for Mental Health (UK). Children's Attachment: Attachment in Children and Young People Who Are Adopted from Care, in Care or at High Risk of Going into Care. London: National Institute for Health and Care Excellence (NICE); 2015 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK338143/
PubMed 26741018Looked-after children and young people. London: National Institute for Health and Care Excellence (NICE); 2021 Oct 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK575858/
PubMed 34941234Dinkler L, Lundstrom S, Gajwani R, Lichtenstein P, Gillberg C, Minnis H. Maltreatment-associated neurodevelopmental disorders: a co-twin control analysis. J Child Psychol Psychiatry. 2017 Jun;58(6):691-701. doi: 10.1111/jcpp.12682. Epub 2017 Jan 17.
PubMed 28094432
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships in Good Hands Trial: Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy for Abused and Neglected Young Children With Maltreatment-associated Problems and Their Parents
- ClinicalTrials.gov ID
- NCT04187911
- Acronym / sponsor ID
- RIGHT / NIHR127801
- Conditions
- Mental Health, Psychiatric Problems, Child Neglect, Maltreatment, Adoption, Child Behaviour Problem
- Keywords
- Feasibility, Randomised, Optimisation, Partnerships, Cost effectiveness, Clinical effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, University of Oxford, University of Nottingham
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research question is: Can the research recommend better ways for social care and health services to work work together to help adoptive and foster families? Can a therapy called DDP improve the mental health of 5-12 year old fostered or adopted children? Is DDP worth the commitment families need to give to it - and the extra cost to the services that deliver it? More than half of adopted or fostered children in the UK have mental health problems including ADHD (i.e. hyperactivity, impulsive behaviour and poor concentration), antisocial behaviour and problems with relationships. Abused and neglected children are more likely than others to have problems in school, become homeless, get involved in crime and even die young (e.g. from suicide), yet there are no fully tested treatments for such complex mental health problems. This is a huge problem because early treatment could greatly improve children's life chances - and reduce strain on health and social care budgets.
There is a Dyadic Developmental Psychotherapy (DDP) a parent-child therapy that takes around 20 sessions and focusses on "Playfulness, Acceptance, Curiosity and Empathy". There is not yet available really good evidence for or against it: many UK therapists like DDP, but it is a big commitment for families: once a week for about six months children will need time off school, the parents will need time off work - and this can be hard to explain to school friends, colleagues and bosses. Research team doesn't just need to know if DDP improves children's mental health - they also need to know if the commitment needed is worth it for families and whether the costs to services outweigh the benefits.
In PHASE 1 the research team will find out whether DDP can work smoothly in the three different settings where it is usually delivered: the NHS, Social Care and Private Practice. Many abused children need other medical and psychiatric support so, the research will assess whether children can get any additional assessments or referrals they may need .
In PHASE 2, the research team plans to find out if it is practically possible to run a high quality trial of DDP. This phase will involve 60 families to find out if they are happy to take part (whether offered DDP or usual services). If all goes to plan, these 60 families will contribute to the final results, along with the 180 families involved in the next PHASE 3 when the research team will test whether DDP is better than usual services and, if it is, whether the improvements in child mental health outweigh the costs.
What impact will the research have? This study will make recommendations about how services should work together to help abused and neglected children and their families. If the researcher team finds that DDP is worth the time and money, it could improve the mental health of abused and neglected children across the world.
Detailed description
Abused and neglected children are at extremely high lifetime risk of psychiatric disorder placing a huge burden on health/social care services and society. Virtually all 92,000 children adopted or fostered in the UK have suffered abuse or neglect, therefore risking profoundly negative outcomes in important areas of development including problematic social relationships, academic underachievement and involvement in crime. These disadvantages can lead to negative spirals of poor health and social inequality. Early intervention can greatly improve their life chances, yet there are no adequate psychosocial treatment strategies or care pathways to address the needs of maltreated children. Psychiatric problems of maltreated children are characterised by complexity. They have experienced extreme environmental risk and are at higher genetic risk than peers. Many also struggle to develop and maintain healthy family relationships. Neurodevelopmental disorders such as Attention Deficit/Hyperactivity Disorder (ADHD) and Autism often co-exist with disorders arising from the abuse and neglect such as Conduct Disorder, Attachment Disorders and Post Traumatic Stress Disorder (PTSD) with devastating consequences for lifelong mental health and development. To reflect this complexity, research team uses the overarching term Maltreatment-Associated Psychiatric Problems (MAPP).
The proposed project is a three-phase development and exploratory trial of Clinical and cost-effectiveness of Dyadic Developmental Psychotherapy (DDP) for abused and neglected children with MAPP and their parents compared to Service as Usual (SAU). The data will be collected in 3 phase trial, through a mixture of qualitative and quantitative methods.
Phase 1 Months 1-9 (9 months)
The first phase will focus on intervention and context optimisation that will take place in 3 sites, each representing one of the UK DDP service delivery contexts: NHS, Social Services and Private Practice. The research questions will be addressed through 24-36 qualitative interviews, and focus groups as well as review meetings at each site, with practitioners and managers involved in delivery of DDP and SAU. The research team will require input from the services practitioners and managers but also Young Peoples' Advisory Groups (YPAG) and Patient, Public, Commissioner Involvement (PPCI) groups.
Phase 2 Months 10-26 (17 months)
To examine the research questions, and minimise bias, the proposed design is a single-blind randomised controlled trial, with two-groups. The aim of this phase will be to respond to research questions such as what are recruitment and retention rates over 6 months; are the trial assessments and interventions acceptable to parents and professionals; are there functional data collection systems enabling future cost effectiveness analysis. This phase will also assess fidelity to the DDP model and whether the care pathways to CAMHS are maintained throughout.
The research team will aim to recruit around 60 families. The potential participants will be identified and approached by their usual service provider. The usual service research administrator will ensure eligible families receive the study participant information leaflet to learn about the study. Once the interest of the family to take part in the trial is confirmed, a research nurse will contact interested families 24 hours later, to discuss the study further and seek consent. Families that confirm their willingness to participate will be invited for two study visits one at baseline, shortly after joining study and second visit after 12 months.
On completion of the baseline data collection, consenting families will be individually randomised 1:1 to DDP or SAU, stratified by site. Individuals who consent to take part will have an equal chance of being randomised to either group. One group will be included in the DDP intervention. The second group will take part in the Services as Usual. The research assistant with responsibility for collecting the data will not know which group participants have been allocated to until the end of the study. The intervention will be delivered by the participant's usual health care team.
Beside the randomised controlled trial, the data will be collected through qualitative research activities to explore social context supporting/hindering child mental health, optimising the contexts of, and processes for, DDP delivery.
Process evaluation
Qualitative work in phase 2 has three main aims:
- To keep abreast of issues and themes uncovered in Phase 1 in the three feasibility trial sites, to ensure ongoing compliance with guidelines for safe DDP delivery and to explore the social context supporting/hindering child mental health in each site including drivers and barriers to optimal DDP/SAU delivery. 6-10 interviews/focus groups will be conducted with therapists, managers and families across the sites.
- To explore the same topics from Phase 1 in the seven putative Phase 3 trial sites - optimising the contexts of, and processes for, DDP delivery in those sites and examining compliance with the DDP delivery guidelines established in Phase 1. 18-26 interviews/focus groups will be conducted across the sites.
- To allow selection of 2-4 additional sites for Phase 3. The number of additional sites required for Phase 3 will be decided based on Phase 2 conversion rates from eligible to consented families and on statistical power considerations based on the standard deviation, in Phase 2, of our principle outcome measure.
Phase 2 will also adopt case study methodology to focus more specifically on the impact of DDP and SAU. The research team will learn through a more in-depth investigation (individual interviews) about participant experience of DDP/SAU and of journeys through service landscapes from the perspectives of the family, therapists, and other key stakeholders involved in the treatment of and care pathways. A small selection of families (2-3 families) will be invited to take part.
Phase 3 Months 27-53 (27 month RCT; (6 month analysis/write-up).
The third phase will continue as a single-blind individually randomised controlled superiority definitive trial. The aim of this phase will be to examine the clinical and cost-effectiveness of DDP for improving child mental health, compared to SAU. The principle outcome will be child's mental health at 12 months post randomisation. The research team will aim to recruit additional 180 families, including phase 2. The study population, interventions, randomisation, data collection, measures, model fidelity and procedures will be as described for Phase 2 unless findings from the process evaluation suggest modifications.
Qualitative evaluation (process evaluation) will continue at the same intensity as Phase 2, with a similar number of interviews/focus groups (24-36 across all sites), to explore delivery drivers/barriers in each service context. The case studies will continue, involving a further 10-12 interviews, to track development over time. The PPCI group and YPAG will have a crucial role in the Process Evaluation, during this phase, in reviewing the qualitative findings with the Process Evaluation Team (PET) and considering how these findings pragmatically feed into future service delivery. Whether or not DDP is eventually found to be cost-effective over services as usual, the process evaluation will yield important information about how mental health services can be safely delivered for maltreated children in different services contexts (i.e. NHS CAMHS, Social Care and Private Practice).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 2 Months 10-26 (17 months) To examine the research questions, and minimise bias, we propose to use a single-blind randomised controlled design, with two-groups. The aim of this phase will be to respond to what recruitment and retention rates are over 6 months and trial assessments and intervention acceptability. We will aim to recruit around 60 families. Consenting families will be individually randomised 1:1 to DDP or SAU, stratified by site. Individuals who consent to take part will have an equal chance of being randomised to either group. Phase 3 (27 months RCT) The third phase will continue as a single-blind individually randomised control superiority definitive trial and will examine clinical and cost-effectiveness of DDP for improving child mental health, compared to SAU. We will aim to recruit additional 180 families. All the procedures will be same as during Phase 2 as explained in details above.
| Arm | Type | Receives |
|---|---|---|
| Intervention - Dyadic Developmental Psychotherapy (DDP) | Experimental | Behavioral: Dyadic Developmental Psychotherapy (DDP)DDP involves approximately twenty 1 hour sessions (usually over 6-9 months) with the adoptive parent/foster carer and child, facilitated by a specifically trained therapist. DDP aims to treat trauma-related problems and Attachment Disorders over about 20 1-hour sessions using the core communication techniques of Playfulness, Acceptance, Curiosity and Empathy (PACE) |
| Control - Services as Usual (SAU) | Active comparator | Behavioral: Services as Usual (SAU)SAU tends to be case-dependent with therapists and social workers attempting to respond to the sometimes changeable needs of the family as needs arise. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Adoptive or permanent foster parents with children aged 5-12 years with symptoms of MAPP or co-occurring mental health conditions and non-psychotherapeutic treatments
Key exclusion criteria (2 listed)
- Families, otherwise eligible, deemed by therapists as not ready for DDP (usually where therapists have concerns about the ability of carers/parents to create a safe/ nurturing enough environment within which DDP can operate)
- Children currently having another psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic Developmental Psychotherapy (DDP)DDP involves approximately twenty 1 hour sessions (usually over 6-9 months) with the adoptive parent/foster carer and child, facilitated by a specifically trained therapist. The role of the therapist during sessions is to maintain an attuned relationship with both child and parent - modelling and encouraging development of a similarly attuned relationship between the child and parent. Therapists are trained to use Playfulness, Acceptance, Curiosity and Empathy (PACE). Our research suggests that key mechanisms of action in DDP might include the active participation of the parents and increased carer empathy and emotional warmth for the child. DDP experts believe this helps build parental capacity for attuned dialogue with the child, co-creation of the meanings underlying child behaviour, and co-regulation of experienced emotions aiming to address four main problem areas: 1. child emotional regulation 2. parental stress 3. the parent-child relationship 4. child mental health. | Behavioural | Intervention - Dyadic Developmental Psychotherapy (DDP) |
| Services as Usual (SAU)SAU tends to be case-dependent with therapists and social workers attempting to respond to the sometimes changeable needs of the family as needs arise. At the time of our UK mapping and modelling work, these services were usually CAMHS based. This may have changed, at least for adoptive families, with the advent of the Adoption Support Fund, which, since May 2015, has allowed local authorities / adoption agencies to apply for funding for "essential therapeutic services". A wide range of interventions, many with a scant evidence base, have been purchased - sometimes from private practitioners - since 2015. In addition, relevant NICE guidelines, particularly those on Looked After and Accommodated Children, Attachment and Child Abuse and Neglect, have been published or updated.Our detailed qualitative and quantitative process evaluation throughout all study Phases will be crucial to carefully characterise SAU in all study sites. | Behavioural | Control - Services as Usual (SAU) |
Primary outcome
Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA)
Time frame: 12 months from baseline
The Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA) is the only measure of Attachment Disorder symptoms that is well validated against clinician diagnosis in middle childhood. Ii is a diagnostic measure that has algorithms compliant with DSM 5 for Reactive Attachment Disorder (RAD) and Disinhibited Social Engagement Disorder (DSED), and it can also be used as a continuous measure (33-items; scoring range 0-66). Previous research suggests a standard deviation of 10.4 for the RADA. Applying the same assumption as for SDQ (correlation between baseline and follow-up of 0.4, correlation within clusters of 0.03, cluster size of 10, retention rate of 0.72), there will be 90% power to detect a difference in RADA of at least 7.25 with a sample size of 190. Typically developing children usually have very low or zero scores on measures for Attachment Disorders so would consider such a change in RADA to be clinically significant.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 12 months from baseline
Strengths and Difficulties Questionnaire (SDQ) has good sensitivity to change in RCTs. Candidate measures are included for the four problem areas in our logic model: child emotion regulation, parental stress, parent-child relationship functioning and child mental health. The research team estimates that 190 families will be required to determine clinical- and cost effectiveness based on findings from an ongoing trial of maltreated pre-school children, information from clinics using the SDQ to evaluate DDP and SDQ population norms. This aims for 90% power, assumes a clinical difference in SDQ of 4 points, a baseline and 1-year follow-up correlation in SDQ of 0.4, a standard deviation in SDQ of 5.8, an intra-cluster correlation of 0.03 (between families who see the same therapist) and a retention rate of 72%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 27663993Vasileva M, Petermann F. Attachment, Development, and Mental Health in Abused and Neglected Preschool Children in Foster Care: A Meta-Analysis. Trauma Violence Abuse. 2018 Oct;19(4):443-458. doi: 10.1177/1524838016669503. Epub 2016 Sep 22.
- Background: PubMed 22867514Harkess-Murphy E, Macdonald J, Ramsay J. Self-harm and psychosocial characteristics of looked after and looked after and accommodated young people. Psychol Health Med. 2013;18(3):289-99. doi: 10.1080/13548506.2012.712706. Epub 2012 Aug 6.
- Background: PubMed 26059537Font SA, Maguire-Jack K. Pathways from childhood abuse and other adversities to adult health risks: The role of adult socioeconomic conditions. Child Abuse Negl. 2016 Jan;51:390-9. doi: 10.1016/j.chiabu.2015.05.013. Epub 2015 Jun 6.
- Background: PubMed 25950577Duncan AE, Auslander WF, Bucholz KK, Hudson DL, Stein RI, White NH. Relationship between abuse and neglect in childhood and diabetes in adulthood: differential effects by sex, national longitudinal study of adolescent health. Prev Chronic Dis. 2015 May 7;12:E70. doi: 10.5888/pcd12.140434.
- Background: PubMed 29197100Rivenbark JG, Odgers CL, Caspi A, Harrington H, Hogan S, Houts RM, Poulton R, Moffitt TE. The high societal costs of childhood conduct problems: evidence from administrative records up to age 38 in a longitudinal birth cohort. J Child Psychol Psychiatry. 2018 Jun;59(6):703-710. doi: 10.1111/jcpp.12850. Epub 2017 Dec 2.
- Background: PubMed 29808490Burt SA, Hyde LW, Frick PJ, Jaffee SR, Shaw DS, Tremblay R. Commentary: Childhood conduct problems are a public health crisis and require resources: a commentary on Rivenbark et al. (). J Child Psychol Psychiatry. 2018 Jun;59(6):711-713. doi: 10.1111/jcpp.12930.
- Background: PubMed 26166925Denham SA, Bassett HH, Sirotkin YS, Brown C, Morris CS. "No-o-o-o Peeking": Preschoolers' Executive Control, Social Competence, and Classroom Adjustment. J Res Child Educ. 2015 Apr 1;29(2):212-225. doi: 10.1080/02568543.2015.1008659.
- Background: PubMed 29333987Li D, Chng GS, Chu CM. Comparing Long-Term Placement Outcomes of Residential and Family Foster Care: A Meta-Analysis. Trauma Violence Abuse. 2019 Dec;20(5):653-664. doi: 10.1177/1524838017726427. Epub 2017 Aug 31.
- Background: PubMed 29137868Luchenski S, Maguire N, Aldridge RW, Hayward A, Story A, Perri P, Withers J, Clint S, Fitzpatrick S, Hewett N. What works in inclusion health: overview of effective interventions for marginalised and excluded populations. Lancet. 2018 Jan 20;391(10117):266-280. doi: 10.1016/S0140-6736(17)31959-1. Epub 2017 Nov 12.
- Background: PubMed 18606034Dozier M, Peloso E, Lewis E, Laurenceau JP, Levine S. Effects of an attachment-based intervention on the cortisol production of infants and toddlers in foster care. Dev Psychopathol. 2008 Summer;20(3):845-59. doi: 10.1017/S0954579408000400.
- BackgroundNelson CA, Fox NA, Zeanah CH. Developmental Psychopathology 2016:1-37.
- BackgroundWright B, Barry M, Hughes E, et al. Health Technology Assessment 2015;19 (52) ISSN 1366- 5278. https://www.ncbi.nlm.nih.gov/books/NBK305116/
- Individual participant dataSharing planned: No
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Minnis, Professor principal investigator
University of Glasgow
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic Developmental Psychotherapy (DDP) and Services as Usual (SAU) in people with Mental Health and Psychiatric Problems, run by University of Glasgow at 16 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?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Helen Minnis, Professor (01412010233, helen.minnis@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA) (time frame: 12 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187911, which also lists 19 linked publications.
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 3 Jun 2024.