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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Reactive Attachment Disorder and Disinhibited Social Engagement Disorder Assessment (RADA)
时间窗: 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)
时间窗: 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%.
次要结局
未报告次要终点
研究者
Helen Minnis
Professor of Child and Adolescent Psychiatry
University of Glasgow
