Title: Helping Families: The Systematic Development and Pilot Randomised Controlled Trial of a Psychoeducational Intervention for Parents with Personality Disorders
Funder: Department of Health and Social Care

Abstract: Design: A phased design with iterative development of screening and intervention manuals (Phase 1), feasibility testing in linked case studies (Phase 2), and a pilot RCT (Phase 3). Setting: Outpatient child and adolescent mental health services (CAMHS) and adult services in two NHS Mental Health Trusts. Target population: Parents with personality disorders whose children have emotional and/or behavioural disorders. Inclusion criteria: Parent: (a) primary parental caregiver; (b) aged 18-65 years; (c) presence of any personality disorder, as identified by SCID-II [1]; (d) proficient in English; (e) capacity to consent. Child: (a) living with index parent; (b) aged 3-16 years; (c) referred to or attending CAMHS; (d) presence of emotional/behavioural disorder, as identified by DAWBA [2] or PAPA [76]. Exclusion criteria: Parent: (a) primary diagnosis of psychosis; (b) insufficient language or cognitive abilities to participate fully in trial procedures; (c) engaged in psychotherapy for own mental health; (d) engaged in focused parenting intervention. Child: (a) not residing with index parent; (b) presence of neurodevelopmental problems or psychosis. Health technologies: A screening manual will set out procedures for identifying and selecting eligible participants. A psychoeducational intervention manual will aim to (a) build rapport and motivation, (b) educate participants about personality disorders and parenting, (c) develop effective parenting skills, (d) reduce parental stress, and (e) improve child and family outcomes. Impacts will be compared against usual care. Outcomes: Child emotional and behavioural problems will be assessed using the Strengths and Difficulties Questionnaire [3], Eyberg Child Behavior Inventory [4], Child Behavior Checklist-Internalising Scale [5] and Concerns About My Child [6]. We will also assess parental mental health (SCL-27 [7]), parenting satisfaction (Kansas Parental Satisfaction Scale [8]), parenting practices (Parenting Scale [9]), family functioning (Family Assessment Device [10]) and treatment alliance (Working Alliance Inventory-SR [11]). Quality-adjusted life years (QALYs) will be measured on the EQ-5D [12]. Costs: Health service use will be measured using the Client Service Receipt Inventory [13] and costs calculated by combining data with appropriate unit costs. Sample size: Phase 1 will establish service and user consultation focus groups (each N=10). In Phase 2, there will be 12 single case studies and 24 key informant interviews. In Phase 3, N=70 will provide a sufficiently precise feasibility estimate (95% CI .67 -.93), based on an expected intervention completion rate of 80% and a minimum feasibility objective of >65%; and obtain stable estimates of population variances for future power calculations [15]. Process evaluation will include N=30 informants. Timetable: The project will run for 37 months. Phase 1 (9 months) will develop clinical manuals. Phase 2 (9 months) will train therapists, undertake feasibility testing and refine manuals. Phase 3 (19 months) will complete a pilot RCT, allowing 7 months for recruitment (5 participants per Trust/month), 3 months for treatment, 6 months for follow-up and 3 months for final analysis and dissemination. Team expertise: We have assembled a strong multidisciplinary team with expertise in parenting interventions, personality disorders, service user involvement, clinical trials, qualitative methods and health economics.

Lay abstract: This research will develop and test a new psychological intervention that spans two important fields in mental health: adult personality disorders and child emotional and behavioural difficulties. Personality disorder refers to the enduring problems that some people have in managing their feelings and in relating to others. People with a personality disorder are highly sensitive to stress and prone to extreme mood swings, self-harm, substance use and interpersonal challenges. Such difficulties affect 4% of all adults in the UK and 40% of adults in mental health services, with high associated costs to the NHS and social services. Emotional and behavioural problems affect nearly 1 in 10 children. Common examples are disruptive behaviour and anxiety. These can interfere with family life, friendships and school achievement, and increase long-term risks for poor adult mental health, substance use, unemployment and crime. The likelihood of severe and persistent problems is increased when a parent has a personality disorder. This is because personality difficulties can make it harder for a parent to provide the consistent care and nurture required for healthy child development. Having a child with emotional and behavioural difficulties is also stressful in itself, and may worsen a parent’s own mental health. Routinely available parenting interventions often achieve worse outcomes when parents have mental health problems. Our research aims to improve care for families with needs in both of these areas. We will focus on psychoeducation, which is a widely used approach in healthcare that teaches service users and carers about the nature of health conditions and useful ways of managing symptoms and impacts. Other research has shown that psychoeducational support is generally effective at helping parents to manage children’s difficulties. We have previously developed and evaluated a promising psychoeducational treatment for adults with personality disorder, and another for parents with complex psychosocial needs. Phase 1 of the proposed research will integrate these two existing treatments to create the new psychoeducational intervention manual required in the call. We will also produce a screening manual detailing suitable methods for identifying and selecting eligible parents. We will work closely with service users and clinicians to ensure that our methods are practical, acceptable to parents and alert to the ethical issues involved. In Phase 2, trained clinicians will deliver the intervention to 12 consenting parents. The parents will complete assessments and take part in interviews about their experiences. This information will then be used to refine our screening and intervention methods where necessary. Phase 3 will involve a pilot trial to compare the newly refined intervention with the usual care that parents receive in two NHS Mental Health Trusts. Seventy consenting parents will be allocated at random to receive (a) the new intervention or (b) usual care. Parents will complete follow-up assessments and interviews after the intervention and six months later. The pilot trial will carefully test research and clinical procedures to obtain reliable information about what is feasible, effective and acceptable for participants. The results will show whether the intervention can and should be tested in a larger, more definitive trial with a view to wider use in the NHS.

Research activity codes: 5.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH