ParentingNCT03374904
Video Feedback to Enhance Parental Mentalization
A study testing Video Feedback in people with Parenting, run by Universidad de Valparaiso at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Video Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 2 Aug 2017to 23 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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. )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Video Feedback Intervention to Enhance Parental Reflective Function in Primary Caregivers of Children With Severe Psychiatric Disorders. Feasibility Randomized Trial
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.
Read more
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.
Read the detailed description
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.
A VF therapy like this will allow implementing a short and economic intervention, which has been used in older children and in parents with mental health problems, as is expected in parents of inpatient psychiatric children. This research also will contribute to explore how PRF relates to children psychopathology.
General objectives
- To assess the feasibility and acceptability of a psychotherapeutic intervention using video feedback in order to improve the PRF in primary caregivers of children and adolescents hospitalized in public inpatient unit.
- To provide data to estimate the parameters required to design a definitive Randomized Control Trial with a psychotherapeutic intervention using VF in order to improve the PRF in primary caregivers of children and adolescents hospitalized in public inpatient unit.
Method This project was approved by the Ethics Committee of the Valparaíso-San Antonio Health Service The research has the support of the head of the Child Psychiatry Unit and the Director of the Psychiatric Hospital.
Participants The research will take place in a public child/adolescent psychiatry ward in Valparaíso in "Hospital Psiquiátrico del Salvador"
In the qualitative study, participants will be a minimum of six primary caregivers of children hospitalized in a psychiatric ward receiving intervention between the ages of 6 and 14, as well as three key players (a therapist, a nurse and chief psychiatrist of the Special Care Unit).
The quantitative study will be conducted amongst all tutors of children hospitalized in a child psychiatry ward between August 2017 and December 2018. The sample will be all parents and/or caregivers that meet the inclusion criteria and wish to participate. The expected sample size is 30 subjects in total; 10 for the control group and 20 for the experimental group. If by December 2018 the total sample has not been met, more subjects will be recruited in order to achieve the sample size. A clinical essay having 30 subjects has been proposed because an intervention of these characteristics has not been performed in Chile; so the impact of the effect must first be estimated in order to assess the feasibility for a future multi-centric clinical trail. This is the reason behind piloting the present study.
Procedure
Qualitative study. Two semi-structured interview scripts will be performed.
- One script aims to gain full grasp of the subjective experience gained by intervention participants regarding the perceived workshop satisfaction and follow-up.
- The second script will be aimed at key institutional information holders, aiming to collect information pertinent to the feasibility of performing such an intervention. Questions will focus on analyzing the necessary resources needed and impact the workshop may have in the functioning of the child psychiatric ward.
The interviews will be performed by physicians undergoing a psychiatrist specialization and/or a psychologist who is not participating in the intervention.
Quantitative Study
At the onset of hospitalization, all caregivers meeting inclusion criteria must provide an informed consent form in order to participate in the study. Children must provide an informed approval after caregivers have provided their consent.
All caregivers that participate in the study will receive an array of instruments upon entering, subsequently randomized between the control groups and those intervened. If any mental health problem is detected in caregivers it will be made a referral for her or him to get special support according to the problem detected
Both groups of caregivers along with their child receive the same regular care and treatments they would normally receive from a inpatient unit. Since both groups will be subject to a larger intervention, the aim of a future randomized control trial will be to objectify how much VF boosts the improvement of PRF during a child's psychiatric hospitalization.
Intervention Interventions will be performed by the principal investigator and by a child clinical psychologist, both trained and supervised in Video Intervention Therapy (VIT). VIT is a technique for performing Video Feedback where behavior-oriented interventions and representational therapy elements are used. This provides a six-step video analysis framework. The video may be filmed at different settings, the only requirement being a visual interaction of the child with his parents.
A four module intervention was designed for this study, each module includes a play session and a VF session. The play session has a workshop format, it has a duration of 45 to 60 minutes, where the caregiver(s) plays freely with the child. During the play session, a five to ten minute video sessions of the dyads will be made. The therapeutic team will then pick approximately 1 minute long excerpts to display in the VF sessions. The VF sessions will occur during the same week and these could be group sessions.
Analysis plan
Qualitative Study The information obtained from the interviews will be analyzed with Grounded Theory model, obtained open codify data.
For the analysis the ATLAS.TI Software will be used, enabling managing and processing text data groups.
Quantitative Study
- A descriptive statistic will be performed to compare the control group and the intervened group regarding clinical and sociodemographic variables.
- It will be also presenting descriptive statistic on eligibility rate, recruitment rate, and compliance.
- To determine Effect Size and Intra Class Correlation results will be analyzed using a multiple linear regression, multi level model with randomized and fixed interception.
Quantitative data will be analyzed using STATA 14.
- Conditions
- Parenting
- Being tested
- Video Feedback, Control Group
- Keywords
- Parenting, Parental Mentalization, Parental Reflective Function, Child Psychopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video FeedbackBehavioural
Also called Video Intervention Therapy
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.
Control GroupBehavioural
Also called Treatment us Usual
Play therapy will be administered once a week plus inpatient treatment as usual for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in control group will attend to four session of Play Therapy plus inpatient treatment as usual during four weeks Receives: Behavioral: Control Group |
| Video Feedback | Experimental | Once a week, after play therapy, individual or group video feedback session will be done. Receives: Behavioral: Video Feedback; Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of delivering the intervention
Estimate the proportion of the quantity of performed sessions against the quantity of planned VF sessions.
Measured: Through study completion, approximately 18 months
Feasibility as measured by participant retention
Number of participants who remain in the study at the 12 weeks follow up
Measured: Through study completion, approximately 21 months
Feasibility of recruitment
Estimate the proportion of caregivers who meet eligibility criteria and accept the invitation to participate in the study (recruiting rate)
Measured: Through study completion, approximately 18 months
Acceptability as measured by compliance-to-intervention rate
proportion of caregivers that complete the intervention against the quantity of randomized.
Measured: Through study completion, approximately 18 months
Change over time in Caregiver's Parental Reflective Function
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.
Measured: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5)
Secondary outcomes (6)
Acceptability of the intervention by primary caregivers
Satisfaction and related factors from the caregivers perspective that participate in the VF intervention, it will be assessed through a qualitative semi-structured interview
Measured: 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
Acceptability of performing a novel intervention from health professionals it will be assessed through a qualitative semi-structured interview.
Measured: Through study completion, approximately 21 months
Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD-SQ) 12 item version
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.
Measured: Baseline (T0)
Change over time The General Health Questionnaire (GHQ-12) in Caregivers
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
Measured: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5)
Change over time in Strengths and Difficulties Questionnaire (SDQ) in Children
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
Measured: 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
Change in Severity of Psychopathology with Clinical Global Impression Scale (CGAS),
Measured: Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start2 Aug 2017
- Primary completion29 Jan 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to intervention or control group at a 2:1 ratio
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, University of Chile
- Responsible party
- Principal investigator, Fanny Leyton, Universidad de Valparaiso
- Investigators
- Fanny Leyton, Md, Principal investigator, Hospital Psiquiátrico del Salvador. Universidad de Valparaíso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374904
- Sponsor's protocol ID
- 0020173081
- Status last verified
- Apr 2019
- First submitted
- 19 Oct 2017
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bakermans-Kranenburg MJ, van IJzendoorn MH, Juffer F. Less is more: meta-analyses of sensitivity and attachment interventions in early childhood. Psychol Bull. 2003 Mar;129(2):195-215. doi: 10.1037/0033-2909.129.2.195.
PubMed 12696839Beebe B. Mother-infant research informs mother-infant treatment. Psychoanal Study Child. 2005;60:7-46. doi: 10.1080/00797308.2005.11800745.
PubMed 16649674Benbassat N, Priel B. Parenting and adolescent adjustment: the role of parental reflective function. J Adolesc. 2012 Feb;35(1):163-74. doi: 10.1016/j.adolescence.2011.03.004. Epub 2011 Apr 16.
PubMed 21497896Fukkink RG. Video feedback in widescreen: a meta-analysis of family programs. Clin Psychol Rev. 2008 Jul;28(6):904-16. doi: 10.1016/j.cpr.2008.01.003. Epub 2008 Feb 5.
PubMed 18359136Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.
PubMed 6639293Steele M, Steele H, Bate J, Knafo H, Kinsey M, Bonuck K, Meisner P, Murphy A. Looking from the outside in: the use of video in attachment-based interventions. Attach Hum Dev. 2014;16(4):402-15. doi: 10.1080/14616734.2014.912491.
PubMed 24972107Facchini S, Martin V, Downing G. Pediatricians, Well-Baby Visits, and Video Intervention Therapy: Feasibility of a Video-Feedback Infant Mental Health Support Intervention in a Pediatric Primary Health Care Setting. Front Psychol. 2016 Feb 16;7:179. doi: 10.3389/fpsyg.2016.00179. eCollection 2016.
PubMed 26909063Fonagy P, Target M. Bridging the transmission gap: an end to an important mystery of attachment research? Attach Hum Dev. 2005 Sep;7(3):333-43. doi: 10.1080/14616730500269278.
PubMed 16210243Ortuno-Sierra J, Aritio-Solana R, Fonseca-Pedrero E. Mental health difficulties in children and adolescents: The study of the SDQ in the Spanish National Health Survey 2011-2012. Psychiatry Res. 2018 Jan;259:236-242. doi: 10.1016/j.psychres.2017.10.025. Epub 2017 Oct 18.
PubMed 29091822Camoirano A. Mentalizing Makes Parenting Work: A Review about Parental Reflective Functioning and Clinical Interventions to Improve It. Front Psychol. 2017 Jan 20;8:14. doi: 10.3389/fpsyg.2017.00014. eCollection 2017.
PubMed 28163690Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
PubMed 27965879Setoya Y, Saito K, Kasahara M, Watanabe K, Kodaira M, Usami M. Evaluating outcomes of the child and adolescent psychiatric unit: A prospective study. Int J Ment Health Syst. 2011 Mar 31;5:7. doi: 10.1186/1752-4458-5-7.
PubMed 21453481Leyton F, Olhaberry M, Moran J, De la Cerda C, Leon MJ, Sieverson C, Alfaro A, Hernandez C, Alvardo R, Steele H. Video Intervention Therapy for primary caregivers in a child psychiatry unit: a randomized feasibility trial. Trials. 2021 Oct 30;22(1):754. doi: 10.1186/s13063-021-05668-w.
PubMed 34717750Leyton F, Olhaberry M, Alvarado R, Rojas G, Duenas LA, Downing G, Steele H. Video feedback intervention to enhance parental reflective functioning in primary caregivers of inpatient psychiatric children: protocol for a randomized feasibility trial. Trials. 2019 May 14;20(1):268. doi: 10.1186/s13063-019-3310-y.
PubMed 31088531
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Feedback Intervention to Enhance Parental Reflective Function in Primary Caregivers of Children With Severe Psychiatric Disorders. Feasibility Randomized Trial
- ClinicalTrials.gov ID
- NCT03374904
- Acronym / sponsor ID
- 0020173081
- Conditions
- Parenting
- Keywords
- Parenting, Parental Mentalization, Parental Reflective Function, Child Psychopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, University of Chile
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
A VF therapy like this will allow implementing a short and economic intervention, which has been used in older children and in parents with mental health problems, as is expected in parents of inpatient psychiatric children. This research also will contribute to explore how PRF relates to children psychopathology.
General objectives
- To assess the feasibility and acceptability of a psychotherapeutic intervention using video feedback in order to improve the PRF in primary caregivers of children and adolescents hospitalized in public inpatient unit.
- To provide data to estimate the parameters required to design a definitive Randomized Control Trial with a psychotherapeutic intervention using VF in order to improve the PRF in primary caregivers of children and adolescents hospitalized in public inpatient unit.
Method This project was approved by the Ethics Committee of the Valparaíso-San Antonio Health Service The research has the support of the head of the Child Psychiatry Unit and the Director of the Psychiatric Hospital.
Participants The research will take place in a public child/adolescent psychiatry ward in Valparaíso in "Hospital Psiquiátrico del Salvador"
In the qualitative study, participants will be a minimum of six primary caregivers of children hospitalized in a psychiatric ward receiving intervention between the ages of 6 and 14, as well as three key players (a therapist, a nurse and chief psychiatrist of the Special Care Unit).
The quantitative study will be conducted amongst all tutors of children hospitalized in a child psychiatry ward between August 2017 and December 2018. The sample will be all parents and/or caregivers that meet the inclusion criteria and wish to participate. The expected sample size is 30 subjects in total; 10 for the control group and 20 for the experimental group. If by December 2018 the total sample has not been met, more subjects will be recruited in order to achieve the sample size. A clinical essay having 30 subjects has been proposed because an intervention of these characteristics has not been performed in Chile; so the impact of the effect must first be estimated in order to assess the feasibility for a future multi-centric clinical trail. This is the reason behind piloting the present study.
Procedure
Qualitative study. Two semi-structured interview scripts will be performed.
- One script aims to gain full grasp of the subjective experience gained by intervention participants regarding the perceived workshop satisfaction and follow-up.
- The second script will be aimed at key institutional information holders, aiming to collect information pertinent to the feasibility of performing such an intervention. Questions will focus on analyzing the necessary resources needed and impact the workshop may have in the functioning of the child psychiatric ward.
The interviews will be performed by physicians undergoing a psychiatrist specialization and/or a psychologist who is not participating in the intervention.
Quantitative Study
At the onset of hospitalization, all caregivers meeting inclusion criteria must provide an informed consent form in order to participate in the study. Children must provide an informed approval after caregivers have provided their consent.
All caregivers that participate in the study will receive an array of instruments upon entering, subsequently randomized between the control groups and those intervened. If any mental health problem is detected in caregivers it will be made a referral for her or him to get special support according to the problem detected
Both groups of caregivers along with their child receive the same regular care and treatments they would normally receive from a inpatient unit. Since both groups will be subject to a larger intervention, the aim of a future randomized control trial will be to objectify how much VF boosts the improvement of PRF during a child's psychiatric hospitalization.
Intervention Interventions will be performed by the principal investigator and by a child clinical psychologist, both trained and supervised in Video Intervention Therapy (VIT). VIT is a technique for performing Video Feedback where behavior-oriented interventions and representational therapy elements are used. This provides a six-step video analysis framework. The video may be filmed at different settings, the only requirement being a visual interaction of the child with his parents.
A four module intervention was designed for this study, each module includes a play session and a VF session. The play session has a workshop format, it has a duration of 45 to 60 minutes, where the caregiver(s) plays freely with the child. During the play session, a five to ten minute video sessions of the dyads will be made. The therapeutic team will then pick approximately 1 minute long excerpts to display in the VF sessions. The VF sessions will occur during the same week and these could be group sessions.
Analysis plan
Qualitative Study The information obtained from the interviews will be analyzed with Grounded Theory model, obtained open codify data.
For the analysis the ATLAS.TI Software will be used, enabling managing and processing text data groups.
Quantitative Study
- A descriptive statistic will be performed to compare the control group and the intervened group regarding clinical and sociodemographic variables.
- It will be also presenting descriptive statistic on eligibility rate, recruitment rate, and compliance.
- To determine Effect Size and Intra Class Correlation results will be analyzed using a multiple linear regression, multi level model with randomized and fixed interception.
Quantitative data will be analyzed using STATA 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to intervention or control group at a 2:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Control GroupPatients in control group will attend to four session of Play Therapy plus inpatient treatment as usual during four weeks |
| Video Feedback | Experimental | Behavioral: Video Feedback, Behavioral: Control GroupOnce a week, after play therapy, individual or group video feedback session will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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. )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video FeedbackAlso: Video Intervention Therapyfirst, 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. | Behavioural | Video Feedback |
| Control GroupAlso: Treatment us UsualPlay therapy will be administered once a week plus inpatient treatment as usual for 4 weeks | Behavioural | Control Group, Video Feedback |
Primary outcome
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.
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
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)
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.
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.
6 secondary outcomes
Acceptability of the intervention by primary caregivers
Time frame: 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
Time frame: Through study completion, approximately 21 months
Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD-SQ) 12 item version
Time frame: Baseline (T0)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 12696839Bakermans-Kranenburg MJ, van IJzendoorn MH, Juffer F. Less is more: meta-analyses of sensitivity and attachment interventions in early childhood. Psychol Bull. 2003 Mar;129(2):195-215. doi: 10.1037/0033-2909.129.2.195.
- Background: PubMed 16649674Beebe B. Mother-infant research informs mother-infant treatment. Psychoanal Study Child. 2005;60:7-46. doi: 10.1080/00797308.2005.11800745.
- Background: PubMed 21497896Benbassat N, Priel B. Parenting and adolescent adjustment: the role of parental reflective function. J Adolesc. 2012 Feb;35(1):163-74. doi: 10.1016/j.adolescence.2011.03.004. Epub 2011 Apr 16.
- Background: PubMed 18359136Fukkink RG. Video feedback in widescreen: a meta-analysis of family programs. Clin Psychol Rev. 2008 Jul;28(6):904-16. doi: 10.1016/j.cpr.2008.01.003. Epub 2008 Feb 5.
- Background: PubMed 6639293Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.
- Background: PubMed 24972107Steele M, Steele H, Bate J, Knafo H, Kinsey M, Bonuck K, Meisner P, Murphy A. Looking from the outside in: the use of video in attachment-based interventions. Attach Hum Dev. 2014;16(4):402-15. doi: 10.1080/14616734.2014.912491.
- Background: PubMed 26909063Facchini S, Martin V, Downing G. Pediatricians, Well-Baby Visits, and Video Intervention Therapy: Feasibility of a Video-Feedback Infant Mental Health Support Intervention in a Pediatric Primary Health Care Setting. Front Psychol. 2016 Feb 16;7:179. doi: 10.3389/fpsyg.2016.00179. eCollection 2016.
- Background: PubMed 16210243Fonagy P, Target M. Bridging the transmission gap: an end to an important mystery of attachment research? Attach Hum Dev. 2005 Sep;7(3):333-43. doi: 10.1080/14616730500269278.
- Background: PubMed 29091822Ortuno-Sierra J, Aritio-Solana R, Fonseca-Pedrero E. Mental health difficulties in children and adolescents: The study of the SDQ in the Spanish National Health Survey 2011-2012. Psychiatry Res. 2018 Jan;259:236-242. doi: 10.1016/j.psychres.2017.10.025. Epub 2017 Oct 18.
- Background: PubMed 28163690Camoirano A. Mentalizing Makes Parenting Work: A Review about Parental Reflective Functioning and Clinical Interventions to Improve It. Front Psychol. 2017 Jan 20;8:14. doi: 10.3389/fpsyg.2017.00014. eCollection 2017.
- Background: PubMed 27965879Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
- Background: PubMed 21453481Setoya Y, Saito K, Kasahara M, Watanabe K, Kodaira M, Usami M. Evaluating outcomes of the child and adolescent psychiatric unit: A prospective study. Int J Ment Health Syst. 2011 Mar 31;5:7. doi: 10.1186/1752-4458-5-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny Leyton, Md principal investigator
Hospital Psiquiátrico del Salvador. Universidad de Valparaíso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Feedback in people with Parenting, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivering the intervention (time frame: Through study completion, approximately 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374904, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019; AzTrials last refreshed its copy on 30 Oct 2026.