Relationships in Good Hands - Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy

NCT04187911 | Recruiting DMC

• 2 other identifiers: NIHR127801L19083
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 16

Brief 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 - 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.

Conditions

Mental Health; Psychiatric Problems; Child Neglect; Maltreatment; Adoption; Child Behaviour Problem; DDP

Keywords

Feasibility; Randomised; Optimisation; Partnerships; Cost effectiveness; Clinical effectiveness

Outcome Measures

Primary Outcomes (2)

• 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.

  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%.

  12 months from baseline

Study Arms (2)

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)

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.

Behavioral: Services as Usual (SAU)

Interventions

Dyadic Developmental Psychotherapy (DDP) BEHAVIORAL

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.

Intervention - Dyadic Developmental Psychotherapy (DDP)

Services as Usual (SAU) BEHAVIORAL

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.

Control - Services as Usual (SAU)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Oxford: collaborator
• University of Nottingham: collaborator

Study Sites (16)

Lanarkshire

Lanark, Scotland, United Kingdom

RECRUITING

Vale Valleys and Cardiff Adoption Collaborative

Barry, United Kingdom

RECRUITING

Bedford Borough Council

Bedford, United Kingdom

RECRUITING

Birmingham Children's Trust

Birmingham, United Kingdom

RECRUITING

Bradford District Care Foundation Trust

Bradford, United Kingdom

ACTIVE NOT RECRUITING

One Adoption South Yorkshire

Doncaster, United Kingdom

RECRUITING

Blaenau Gwent County Borough Council

Ebbw Vale, United Kingdom

RECRUITING

South London and Maudsley NHS Foundation Trust

London, United Kingdom

RECRUITING

Norfolk and Suffolk NHS Foundation Trust

Norwich, United Kingdom

RECRUITING

Norfolk County Council

Norwich, United Kingdom

RECRUITING

Nottingham City Council

Nottingham, United Kingdom

RECRUITING

Nottinghamshire County Council (Adoption East Midlands)

Nottingham, United Kingdom

RECRUITING

Oxfordshire

Oxford, United Kingdom

RECRUITING

Central Bedfordshire Council

Shefford, United Kingdom

RECRUITING

Hertfordshire County Council

Stevenage, United Kingdom

RECRUITING

Adoption@Heart

Wolverhampton, United Kingdom

WITHDRAWN

Related Publications (19)

• 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.

  PMID: 27663993 BACKGROUND

• 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.

  PMID: 22867514 BACKGROUND

• 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.

  PMID: 26059537 BACKGROUND

• 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.

  PMID: 25950577 BACKGROUND

• 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.

  PMID: 29197100 BACKGROUND

• 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.

  PMID: 29808490 BACKGROUND

• 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.

  PMID: 26166925 BACKGROUND

• 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.

  PMID: 29333987 BACKGROUND

• 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.

  PMID: 29137868 BACKGROUND

• 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.

  PMID: 18606034 BACKGROUND

• Nelson CA, Fox NA, Zeanah CH. Developmental Psychopathology 2016:1-37.

  BACKGROUND

• 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.

  PMID: 26177494 BACKGROUND

• 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/

  PMID: 26741018 BACKGROUND

• 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/

  PMID: 34941234 BACKGROUND

• 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.

  PMID: 28094432 BACKGROUND

• 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.

  PMID: 27914236 BACKGROUND

• . Van der Kolk BA. Psychiatric annals 2017;35:401-8.

  BACKGROUND

• 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.

  PMID: 23250477 BACKGROUND

• 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.

  PMID: 23710133 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Helen Minnis, Professor

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Minnis, Professor

CONTACT

01412010233; helen.minnis@glasgow.ac.uk

Lorna Ginnell

CONTACT

07478293914; Lorna.Ginnell@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Child and Adolescent Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: May 1, 2020
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (16)