Video Feedback Intervention to Enhance Parental Reflective Function in Primary Caregivers of Children With Severe Psychiatric Disorders. Feasibility Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of delivering the intervention
研究概览
简要总结
The objective of this study is to implement a Video Feedback (VF) intervention to enhance Parental Reflective Function in primary caregivers of inpatient psychiatric children. Because there is no published research using VF with parents of children with severe psychopathology and in hospitalized context, this study is a pilot study.
The research will include a qualitative and quantitative study; it will take place in a public hospital in Valparaíso, Chile. In the qualitative study, participants will be six primary caregivers who received the intervention and three stakeholders from Child Unit. For caregivers a semi-structured interview will be applied to know subjective experience gained by intervention regarding the perceived satisfaction. For health professional also a semi-structured interview will be applied to collect information pertinent to the feasibility of performing such intervention. The information obtained from the interviews will be analyzed with Grounded Theory model.
The quantitative study will be conducted amongst all tutors of children aged between 6 and 14 hospitalized in a child psychiatry ward between August 2017 and December 2018. The expected sample size is 30 subjects in total; 10 for the control group and 20 for the experimental group.
A four module of Video Intervention Therapy (VIT) was designed, each module includes a (video recorded) play session and a group VF session.
The evaluation of the caregivers at the beginning of the intervention will include a psychosocial questionnaire, GHQ-12 , Five Minutes Speech Sample (FMSS) where RF will be codified, Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD.SQ). The Strengths and Difficulties Questionnaire will be applied to children, in addition to the Children Global Assessment Scale, (CGAS). After every VF session a new FMSS, GHQ-12 and CGAS will be made. A follow-up will be performed three months after the beginning of the intervention with FMSS, GHQ-12 for caregivers and SDQ and CGAS for children.
To determine Effect Size and Intra Class Correlation, the results will be analyzed using a multiple linear regression.
详细描述
One of the challenges when a child is hospitalized is working with the family, there is an enormous evidence relating family factors with onset of psychopathology and pour outcomes in children. Usually treatment includes parental support or family therapy, but most parents attend to few sessions.
Mentalization is defined as the capacity to understand and interpret one's own behavior and those of others as an expression of mental states, such as feelings, thoughts, fantasies, beliefs and desires. Reflective function (RF) is the operational definition of mentalization. Parental mentalizing is considered to have important implications for the development of self-regulation in Children.
Video assisted therapy has demonstrated to be a powerful tool in promoting change in parent-child relationships with few sessions.
The present study
To assess a short program aimed at improving Parental Reflective Function (PRF) during the hospitalization of children and early adolescents admitted to a psychiatric unit, a randomized pilot psychotherapeutic intervention using video feedback has been designed as a clinical trial. There is ample evidence of the usefulness of video feedback to increase sensitivity and PRF in children up to 5 years, but in older children the evidence is limited. There are no known published randomized clinical trials using video feedback in parents of children admitted for psychiatric reasons.
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)
盲法说明
Interview analysis, for ascertaining the level of PRF will be done by an encoder highly trained in said techniques. Transcriptions will be anonymous in order to mask the identity of the caregiver. Whether the caregiver belongs to a control or intervened group will also be masked when working in transcriptions.
Due to the characteristics of the intervention, the main researcher will not be masked regarding who receives the intervention and who is in the control group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Figure as a tutor during hospitalization or,
- •Figure as the primary caregiver of the child or adolescent and,
- •Must have a (legal or biological) kinship with the hospitalized child or adolescent.
排除标准
- •Responsible adults that present a severe intellectual deficit or psychotic symptoms or,
- •Institutional caregivers or,
- •Parents that do not care for the child regularly (see the child lees than a week per month, has restraining orders, etc. )
研究组 & 干预措施
Control Group
Patients in control group will attend to four session of Play Therapy plus inpatient treatment as usual during four weeks
干预措施: Control Group (Behavioral)
Video Feedback
Once a week, after play therapy, individual or group video feedback session will be done.
干预措施: Video Feedback (Behavioral)
Video Feedback
Once a week, after play therapy, individual or group video feedback session will be done.
干预措施: Control Group (Behavioral)
结局指标
主要结局
Feasibility of delivering the intervention
时间窗: Through study completion, approximately 18 months
Estimate the proportion of the quantity of performed sessions against the quantity of planned VF sessions.
Feasibility of recruitment
时间窗: Through study completion, approximately 18 months
Estimate the proportion of caregivers who meet eligibility criteria and accept the invitation to participate in the study (recruiting rate)
Acceptability as measured by compliance-to-intervention rate
时间窗: Through study completion, approximately 18 months
proportion of caregivers that complete the intervention against the quantity of randomized.
Change over time in Caregiver's Parental Reflective Function
时间窗: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5)
Parental Reflective Function is obtained from a general codification of the Five Minutes Speech Sample transcription according to the Reflexive Function Evaluation Manual with a scale that goes from -1 (avoidance or rejection of the mentalization) to 9 score points (complete or exceptional RF). A score of 5 reflects a clear understanding of mental states.
Feasibility as measured by participant retention
时间窗: Through study completion, approximately 21 months
Number of participants who remain in the study at the 12 weeks follow up
次要结局
- Acceptability of the intervention by primary caregivers(Following completion of the intervention (4 weeks from allocation))
- Acceptability of the intervention by key stakeholders (a therapist, a psychiatrist and a nurse) of child inpatient unit(Through study completion, approximately 21 months)
- Change over time The General Health Questionnaire (GHQ-12) in Caregivers(Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5))
- Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD-SQ) 12 item version(Baseline (T0))
- Change over time in Strengths and Difficulties Questionnaire (SDQ) in Children(Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5))
- Change over time in Clinical Global Impression Scale (CGAS) in Children(Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5))
研究者
Fanny Leyton
Psychiatrist at Child Inpatient Unit, Principal Investigator
Universidad de Valparaiso