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Trial record 12 of 1497 for:    child psychiatry

Video Feedback to Enhance Parental Mentalization

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ClinicalTrials.gov Identifier: NCT03374904
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
Pontificia Universidad Catolica de Chile
University of Chile
Information provided by (Responsible Party):
Fanny Leyton, Universidad de Valparaiso

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Parenting Behavioral: Video Feedback Behavioral: Control Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to intervention or control group at a 2:1 ratio
Masking: Single (Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Video Feedback Intervention to Enhance Parental Reflective Function in Primary Caregivers of Children With Severe Psychiatric Disorders. Feasibility Randomized Trial
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : January 29, 2019
Actual Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Parenting

Arm Intervention/treatment
Active Comparator: Control Group
Patients in control group will attend to four session of Play Therapy plus inpatient treatment as usual during four weeks
Behavioral: Control Group
Play therapy will be administered once a week plus inpatient treatment as usual for 4 weeks
Other Name: Treatment us Usual

Experimental: Video Feedback
Once a week, after play therapy, individual or group video feedback session will be done.
Behavioral: Video Feedback
first, a play interaction between the child and caregiver is recorded (5 to 10 minutes), then the therapist and caregivers watch together a selected part of the video (1 to 2 minutes) and provide feedback with a six step protocol.
Other Name: Video Intervention Therapy

Behavioral: Control Group
Play therapy will be administered once a week plus inpatient treatment as usual for 4 weeks
Other Name: Treatment us Usual




Primary Outcome Measures :
  1. Feasibility of delivering the intervention [ Time Frame: Through study completion, approximately 18 months ]
    Estimate the proportion of the quantity of performed sessions against the quantity of planned VF sessions.

  2. Feasibility as measured by participant retention [ Time Frame: Through study completion, approximately 21 months ]
    Number of participants who remain in the study at the 12 weeks follow up

  3. Feasibility of recruitment [ Time Frame: 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)

  4. Acceptability as measured by compliance-to-intervention rate [ Time Frame: Through study completion, approximately 18 months ]
    proportion of caregivers that complete the intervention against the quantity of randomized.

  5. Change over time in Caregiver's Parental Reflective Function [ Time Frame: 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.


Secondary Outcome Measures :
  1. Acceptability of the intervention by primary caregivers [ Time Frame: Following completion of the intervention (4 weeks from allocation) ]
    Satisfaction and related factors from the caregivers perspective that participate in the VF intervention, it will be assessed through a qualitative semi-structured interview

  2. Acceptability of the intervention by key stakeholders (a therapist, a psychiatrist and a nurse) of child inpatient unit [ Time Frame: Through study completion, approximately 21 months ]
    Acceptability of performing a novel intervention from health professionals it will be assessed through a qualitative semi-structured interview.

  3. Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD-SQ) 12 item version [ Time Frame: Baseline (T0) ]
    OPD-SQ Auto report instrument that measures the level of structural integration of personality in 12 items, in which people indicate the degree to which they feel accurately described in a 5 point Likert scale. Higher scores are indicators of less structural integration.

  4. Change over time The General Health Questionnaire (GHQ-12) in Caregivers [ Time Frame: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5) ]
    The well-being of parents will be measured using a 12-question questionnaire to measure overall psychological well-being. Total scores range from 0 to 36. Higher scores indicate more psychological problems

  5. Change over time in Strengths and Difficulties Questionnaire (SDQ) in Children [ Time Frame: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5) ]
    The parents' self-reported behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item questionnaire that assesses children's positive and negative attributes, each item uses a 3-point Likert ordinal scale. The answers have a score of 0-2 for the items written negatively and a reverse score of 2-0 for the items written positively. Thus, higher scores indicate more problematic attributes for all the 25 items

  6. Change over time in Clinical Global Impression Scale (CGAS) in Children [ Time Frame: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5) ]
    Change in Severity of Psychopathology with Clinical Global Impression Scale (CGAS),



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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. )

Information from the National Library of Medicine

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): NCT03374904


Locations
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Chile
Hospital Psiquiátrico del Salvador
Valparaíso, Chile
Sponsors and Collaborators
Universidad de Valparaiso
Pontificia Universidad Catolica de Chile
University of Chile
Investigators
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Principal Investigator: Fanny Leyton, Md Hospital Psiquiátrico del Salvador. Universidad de Valparaíso

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fanny Leyton, Psychiatrist at Child Inpatient Unit, Principal Investigator, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT03374904     History of Changes
Other Study ID Numbers: 0020173081
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fanny Leyton, Universidad de Valparaiso:
Parenting
Parental Mentalization
Parental Reflective Function
Child Psychopathology