Relationships in Good Hands - Clinical and Cost-effectiveness of Dyadic Developmental Psychotherapy (RIGHT)
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|ClinicalTrials.gov Identifier: NCT04187911|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : December 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Psychiatric Problems Child Neglect Maltreatment Adoption Child Behaviour Problem DDP||Behavioral: Dyadic Developmental Psychotherapy (DDP) Behavioral: Services as Usual (SAU)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
|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|
|Estimated Study Start Date :||March 1, 2020|
|Estimated Primary Completion Date :||January 30, 2024|
|Estimated Study Completion Date :||January 30, 2024|
Experimental: 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)
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. 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.
Active Comparator: 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.
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. 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.
- 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%.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187911
|Contact: Helen Minnis, Professorfirstname.lastname@example.org|
|Contact: Marcela Gaviganemail@example.com|
|Principal Investigator:||Helen Minnis, Professor||University of Glasgow|