Randomised feasibility trial of the helping families programme-modified: an intensive parenting intervention for parents affected by severe personality difficulties

Background: Specialist parenting intervention could improve coexistent parenting and child mental health difficulties of parents affected by severe personality difficulties. Objective: Conduct a feasibility trial of Helping Families Programme-Modified (HFP-M), a specialist parenting intervention. Design: Pragmatic, mixed-methods trial, 1:1 random allocation, assessing feasibility, intervention acceptability and outcome estimates. Settings: Two National Health Service health trusts and local authority children’s social care. Participants: Parents: (i) primary caregiver, (ii) 18 to 65 years, (iii) severe personality difficulties, (iv) proficient English and (v) capacity for consent. Child: (i) 3 to 11 years, (ii) living with index parent and (iii) significant emotional/behavioural difficulties. Intervention: HFP-M: 16-session home-based intervention using parenting and therapeutic engagement strategies. Usual care: standard care augmented by single psychoeducational parenting session. Outcomes: Primary feasibility outcome: participant retention rate. Secondary outcomes: (i) rates of recruitment, eligibility and data completion, and (ii) rates of intervention acceptance, completion and alliance (Working Alliance Inventory-Short Revised). Primary clinical outcome: child behaviour (Eyberg Child Behaviour Inventory). Secondary outcomes: child mental health (Concerns About My Child, Child Behaviour Checklist-Internalising Scale), parenting (Arnold-O’Leary Parenting Scale, Kansas Parental Satisfaction Scale) and parent mental health (Symptom-Checklist-27). Quantitative data were collected blind to allocation. Results: Findings broadly supported non-diagnostic selection criterion. Of 48 participants recruited, 32 completed post-intervention measures at mean 42 weeks later. Participant retention exceeded a priori rate (HFP-M=18; Usual care=14; 66.7%, 95% CI 51.6% to 79.6%). HFP-M was acceptable, with delivery longer than planned. Usual care had lower alliance rating. Child and parenting outcome effects detected across trial arms with potential HFP-M advantage (effect size range: 0.0 to 1.3). Conclusion: HFP-M is an acceptable and potentially effective specialist parenting intervention. A definitive trial is feasible, subject to consideration of recruitment and retention methods, intervention efficiency and comparator condition. Caution is required in interpretation of results due to reduced sample size. No serious adverse events reported. Trial registration number: ISRCTN1457323