Relationships in Good Hands - Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy
NCT ID: NCT04187911
Last Updated: 2024-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2020-05-01
2025-07-31
Brief Summary
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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.
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Detailed Description
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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:
1. 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.
2. 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.
3. 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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Intervention - 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)
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.
Control - 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children currently having another psychotherapy
5 Years
12 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University of Oxford
OTHER
University of Nottingham
OTHER
University of Glasgow
OTHER
Responsible Party
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Helen Minnis
Professor of Child and Adolescent Psychiatry
Principal Investigators
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Helen Minnis, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Lanarkshire
Lanark, Scotland, United Kingdom
Vale Valleys and Cardiff Adoption Collaborative
Barry, , United Kingdom
Bedford Borough Council
Bedford, , United Kingdom
Birmingham Children's Trust
Birmingham, , United Kingdom
Bradford District Care Foundation Trust
Bradford, , United Kingdom
One Adoption South Yorkshire
Doncaster, , United Kingdom
Blaenau Gwent County Borough Council
Ebbw Vale, , United Kingdom
South London and Maudsley NHS Foundation Trust
London, , United Kingdom
Norfolk and Suffolk NHS Foundation Trust
Norwich, , United Kingdom
Norfolk County Council
Norwich, , United Kingdom
Nottingham City Council
Nottingham, , United Kingdom
Nottinghamshire County Council (Adoption East Midlands)
Nottingham, , United Kingdom
Oxfordshire
Oxford, , United Kingdom
Central Bedfordshire Council
Shefford, , United Kingdom
Hertfordshire County Council
Stevenage, , United Kingdom
Adoption@Heart
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Harkess-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.
Font 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.
Duncan 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.
Rivenbark 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.
Burt 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.
Denham 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.
Li 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.
Luchenski 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.
Dozier 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.
Nelson CA, Fox NA, Zeanah CH. Developmental Psychopathology 2016:1-37.
Wright B, Barry M, Hughes E, Trepel D, Ali S, Allgar V, Cottrill L, Duffy S, Fell J, Glanville J, Glaser D, Hackney L, Manea L, McMillan D, Palmer S, Prior V, Whitton C, Perry A, Gilbody S. Clinical effectiveness and cost-effectiveness of parenting interventions for children with severe attachment problems: a systematic review and meta-analysis. Health Technol Assess. 2015 Jul;19(52):vii-xxviii, 1-347. doi: 10.3310/hta19520.
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/
Looked-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/
Dinkler 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.
Cecil CA, Viding E, Fearon P, Glaser D, McCrory EJ. Disentangling the mental health impact of childhood abuse and neglect. Child Abuse Negl. 2017 Jan;63:106-119. doi: 10.1016/j.chiabu.2016.11.024. Epub 2016 Nov 30.
. Van der Kolk BA. Psychiatric annals 2017;35:401-8.
Kay C, Green J. Reactive attachment disorder following early maltreatment: systematic evidence beyond the institution. J Abnorm Child Psychol. 2013 May;41(4):571-81. doi: 10.1007/s10802-012-9705-9.
Minnis H. Maltreatment-associated psychiatric problems: an example of environmentally triggered ESSENCE? ScientificWorldJournal. 2013 Apr 17;2013:148468. doi: 10.1155/2013/148468. Print 2013.
Other Identifiers
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L19083
Identifier Type: OTHER
Identifier Source: secondary_id
NIHR127801
Identifier Type: -
Identifier Source: org_study_id
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