34863912 true Enhancing the quality of interactions between parents with psychosis and their young children: a feasibility randomised controlled trial of video feedback EMBRACE The primary objective is to assess the feasibility and acceptability of conducting a randomised controlled trial of a brief video feedback intervention (Video Interaction Guidance [VIG]), versus usual care, in parents with a psychotic disorder who are a caregiver of a child aged 2-36 months. The secondary objective is to collect data on pre-post changes on the following clinical outcomes: 1. Parent-child interaction 2. Parental mental health 3. Parenting stress 4. Child social and emotional wellbeing for participants receiving VIG versus participants receiving usual care. Background and study aims Psychosis is a severe mental health problem characterised by unusual sensory experiences and distressing beliefs, difficulties with motivation, and mood problems. Many patients with psychosis are parents, and their symptoms can impact on their ability to tune into their child’s communication and respond sensitively. This impacts on the parent’s and child’s wellbeing and increases the risk of future child mental health problems. There are no interventions supported by research to help this group of parents to interact with their children. We plan to evaluate an approach called video feedback. It involves the therapist and parent watching brief videotaped interactions between the parent and child, to help parents notice moments of positive interaction where they respond sensitively to their child’s communication. This approach helps parents to build on their strengths. While we know that video feedback works with other parent groups, we do not know whether it helps parents with psychosis. Before carrying out a trial to test video feedback with this patient group, this study will pilot the intervention and study procedures to determine if a larger trial is feasible. Who can participate? People aged 16-65 years with a diagnosed psychotic disorder, who are under the care of an NHS mental health team, and who have caregiving responsibilities for a child aged 2-48 months. What does the study involve? People taking part in the study will be divided into two groups. A computer will decide at random if participants are in group 1 (video feedback) or group 2 (treatment as usual), and there is a 50% chance of being put in either group. Those in the video feedback group will receive eight 1-hour video feedback sessions with a trained therapist in their home or the clinic, spaced every 1-2 weeks. The therapist will video the parent and their child playing for a few minutes during some visits. In other visits, the parent will watch short clips from these videos that show positive moments of the parent and their child together, and parents will be asked about what is going well in the videos. Everyone taking part will continue to receive their usual mental health treatment and support in the team. Everyone who takes part will be asked to meet with a research assistant at the beginning of the study, after 4 months and after 7 months. This research assistant does not know which group participants are in. During these research meetings, participants will be asked to complete questionnaires about their mental health, stress, wellbeing of their child, sources of support, and quality of life. The research assistant will also take a brief film clip of the parent and child playing together. At the end of the study some participants will be invited to take part in an interview with a member of the research team to talk about their experiences of the study. The researchers will also interview the therapists about their experience of delivering video feedback, and survey other health practitioners in the recruiting teams to explore their views of the intervention and study. What are the possible benefits and risks of participating? It is not possible at this stage to say whether taking part will be of benefit to participants. We know from other research studies that parents have found video feedback helpful to build on their strengths and increase their parenting confidence. The information we get from this study will help us to improve the support offered to parents with psychosis in the future. The risks of taking part are likely to be small. The research assessments involve parents talking about their mental health and their children, which they may find upsetting. Parents randomised to receive video feedback would need to put some time aside for these appointments. Some people can feel self-conscious watching clips of themselves and can worry whether others will judge them. The therapists are specially trained to help people deal with these feelings if they arise. Where is the study run from? Oxford Health NHS Foundation Trust and Leicestershire Partnership NHS Trust (UK) When is the study starting and how long is it expected to run for? March 2026 to March 2028 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Dr Louise Johns, louise.johns@oxfordhealth.nhs.uk The primary outcome measures relate to the feasibility and acceptability of the trial procedures and intervention. The primary efficacy outcome is parent-child interaction (parental responsiveness), assessed using video clips coded using the Emotional Availability (EA) Scales by trained independent raters, at baseline, 16 weeks, and 28 weeks. The video clips of parents and infants up to 15 months will also be rated on the CARE-index by a trained independent rater at baseline, 16 weeks and 28 weeks. Feasibility parameters measured at baseline, 16 and 28 weeks: 1. Number of patients eligible, approached, and consented to participate 2. Number recruited, recruitment rate, and proportion of mothers and fathers recruited 3. Range and average number of sessions attended 4. Proportion of participants completing all planned intervention sessions 5. Number of participants who withdraw from the study and when they withdraw 6. Any adverse effects of participating in the study 7. Acceptability of the intervention, assessed qualitatively post-intervention 8. Reasons for participants not completing the intervention as planned, assessed qualitatively post-intervention 9. Number of participants who complete the outcome measures at each time point and the completeness of their data, and acceptability of the measures assessed qualitatively post-intervention 1. Parent-child interaction is assessed using video clips coded on the Emotional Availability (EA) Scales by trained independent raters at baseline, 16 weeks, and 28 weeks. Video clips of parents and infants up to 15 months are also coded by independent raters on the CARE-index at baseline, 16 weeks, and 28 weeks. 2. Parental mental health is measured using the Depression, Anxiety and Stress Scale at baseline, 16 and 28 weeks 3. Parenting stress is measured using the Parental Stress Scale at baseline, 16 and 28 weeks 4. Social and emotional wellbeing of children is assessed using the parent-reported Ages and Stages Questionnaire: Social and Emotional at baseline, 16 and 28 weeks 5. Health and social care use by the parent and child is assessed using the Client Service Receipt Inventory (CSRI), adapted for this patient group, at baseline and 28 weeks 6. Parental quality of life is measured using the EQ-5D-5L at baseline, 16 and 28 weeks 7. NHS treatments and service use are extracted from the electronic patient record at baseline and 28 weeks Old ethics approval format Approved 17/10/2025, North of Scotland Research Ethics Committee 2 (North of Scotland Research Ethics Service, Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; gram.nosres@nhs.scot), ref: 25/NS/0120 10.1186/ISRCTN34863912 345724 CPMS: 63188, NIHR: 207967 345724 63188 207967 Interventional Randomized controlled trial Blinded (masking used) Active Single Treatment Not applicable Treatment 2027-12-31T00:00:00.000Z United Kingdom England Slade Site

Horspath Driftway Headington

Oxford England OX3 7JH RNUHE@2.16.840.1.113883.2.1.3.2.4.18.48 Warneford Hospital

Warneford Lane Headington

Oxford England OX3 7JX RNU33@2.16.840.1.113883.2.1.3.2.4.18.48 Whiteleaf Centre

Bierton Road

Aylesbury England HP20 1EG RNUGP@2.16.840.1.113883.2.1.3.2.4.18.48 Leicestershire Partnership NHS Trust Mental Health Services

George Hine House Gipsy Lane Humberstone

Leicester England LE5 0TD RT502@2.16.840.1.113883.2.1.3.2.4.18.48 Merlyn Vaz Health and Social Care Centre

1 Spinney Hill Road

Leicester England LE5 3GH RT5NQ@2.16.840.1.113883.2.1.3.2.4.18.48 Patient false Current inclusion criteria as of 20/07/2026: Parent: 1. Patient of mental health services (at the time of referral to the trial) 2. A clinical diagnosis of schizophrenia spectrum psychosis (non-affective psychosis) (ICD 10 codes F20–29) or bipolar disorder (F31) with psychotic symptoms (affective psychosis) 3. Caregiving responsibilities for child aged 2-48 months 4. Able to speak English or, if not, willing to involve an interpreter to engage in the trial 5. Willing and able to give informed consent Child: 1. Aged between 2 and 48 months at the time of the parent's referral to the trial 2. In regular contact with the participating parent 3. The child’s parent or legal guardian has provided informed consent for their participation in the study procedures Parent qualitative study: 1. Consent to have interviews audio recorded 2. Participation in the study (n = 5); randomised to the intervention arm and having received at least one cycle of VIG (n = 10) Clinician qualitative study: 1. Consent to have interviews audio recorded 2. Experience of either delivering VIG to study participants, or referring a parent to the study, or working with parents with psychosis and young children in the recruiting Trusts Previous inclusion criteria: Parent: 1. Patient of mental health services (at the time of referral to the trial) 2. A clinical diagnosis of schizophrenia spectrum psychosis (non-affective psychosis) (ICD 10 codes F20–29) or bipolar disorder (F31) with psychotic symptoms (affective psychosis) 3. Caregiving responsibilities for child aged 2-36 months 4. Able to speak English or, if not, willing to involve an interpreter to engage in the trial 5. Willing and able to give informed consent Child: 1. Aged between 2 and 36 months at the time of the parent's referral to the trial 2. In regular contact with the participating parent 3. The child’s parent or legal guardian has provided informed consent for their participation in the study procedures Parent qualitative study: 1. Consent to have interviews audio recorded 2. Participation in the study (n = 5); randomised to the intervention arm and having received at least one cycle of VIG (n = 10) Clinician qualitative study: 1. Consent to have interviews audio recorded 2. Experience of either delivering VIG to study participants, or referring a parent to the study, or working with parents with psychosis and young children in the recruiting Trusts Adult All 40 0 Parent: 1. A co-parent is participating in the trial 2. The parent is engaged in another parenting intervention 3. The eligible parent has psychotic symptoms or cognitive difficulties or substance misuse problems that are sufficiently severe to prevent them engaging with the intervention or completing study measures 4. Contact between the parent and child is not permitted by social services 5. Any other factor (for example, current active suicidal plans) which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures. Child: 1. Contact with the participating parent is prohibited by social services or a court order 2. The child is already enrolled in another parenting study 3. A sibling is participating in the trial 2026-03-03T00:00:00.000Z 2027-08-01T00:00:00.000Z Psychosis Mental and Behavioural Disorders Video Interaction Guidance (VIG): VIG is a brief, strengths-based video feedback intervention that uses videotaped interactions of the parent and child to enhance parental responsiveness to the child’s cues. The VIG therapist films parent-child interactions for 5 minutes and then edits the footage to produce three short video clips (up to 30 seconds) of successful interaction that link to the parent’s goals. In the subsequent ‘shared review’ session, the parent and VIG therapist review the selected clips together. Seeing the videos with the therapist allows the parent to build on moments of positive interaction with their child. One cycle of VIG involves filming (session 1), editing (between sessions), and reviewing video clips (session 2). Parents will receive an introductory session, 3 cycles of VIG (one cycle = two sessions, over 2-3 weeks), and a review session. The intervention will be delivered over 8-10 weeks. Sessions last 45-60 minutes and are delivered in the parent’s home or the clinic. Usual Care: All participants will continue to receive usual care from their treating team. Usual care includes care-coordination, psychiatric review, medication, psychological therapy, family therapy and carer support (for the patient’s caregivers), physical health monitoring, peer support, and, in perinatal teams, parenting skills support. We will not ask referrers or clinicians to withhold any treatment offered as part of usual care in either trial arm. Behavioural The datasets generated during and/or analysed during the current study will be available upon reasonable request from Dr Louise Johns (louise.johns@oxfordhealth.nhs.uk). De-identified data will be made available to external researchers subject to the constraints of the consent under which data were collected, with an appropriate data sharing agreement, and after publication of the main study report. Available on request aaf7a521-011a-4a6f-981c-4713a637b8ee 8c0efb40-c810-410f-aeeb-abb174948d36 4598c0db-93b7-4227-8d22-deab6e13e115 Yes Louise Johns https://orcid.org/0000-0003-3355-3202 Scientific

Oxford Early Intervention Service John Sharich House, Slade Site Horspath Driftway

Oxford United Kingdom OX3 7JH - louise.johns@oxfordhealth.nhs.uk Public Oxford Health NHS Foundation Trust Hospital/treatment centre https://ror.org/04c8bjx39 Non-commercial National Institute for Health and Care Research http://dx.doi.org/10.13039/501100000272