Video Feedback to Enhance Parental Mentalization

NCT03374904 | Completed DMC

• 1 other identifier: 0020173081
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parenting

Keywords

Parenting; Parental Mentalization; Parental Reflective Function; Child Psychopathology

Outcome Measures

Primary Outcomes (5)

• Feasibility of delivering the intervention

  Estimate the proportion of the quantity of performed sessions against the quantity of planned VF sessions.

  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

  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)

  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.

  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.

  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

  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

• Operationalized Psychodynamic Diagnosis - Structure Questionnaire (OPD-SQ) 12 item version

  Baseline (T0)

• 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)

• 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)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in control group will attend to four session of Play Therapy plus inpatient treatment as usual during four weeks

Behavioral: Control Group

Video Feedback

EXPERIMENTAL

Once a week, after play therapy, individual or group video feedback session will be done.

Behavioral: Video Feedback; Behavioral: Control Group

Interventions

Video Feedback BEHAVIORAL

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.

Also known as: Video Intervention Therapy

Video Feedback

Control Group BEHAVIORAL

Play therapy will be administered once a week plus inpatient treatment as usual for 4 weeks

Also known as: Treatment us Usual

Control Group; Video Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. )

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Pontificia Universidad Catolica de Chile: collaborator
• University of Chile: collaborator

Study Sites (1)

Hospital Psiquiátrico del Salvador

Valparaíso, Chile

Location

Related Publications (14)

• 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.

  PMID: 12696839 BACKGROUND

• Beebe B. Mother-infant research informs mother-infant treatment. Psychoanal Study Child. 2005;60:7-46. doi: 10.1080/00797308.2005.11800745.

  PMID: 16649674 BACKGROUND

• Benbassat 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.

  PMID: 21497896 BACKGROUND

• Fukkink 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.

  PMID: 18359136 BACKGROUND

• Shaffer 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.

  PMID: 6639293 BACKGROUND

• Steele 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.

  PMID: 24972107 BACKGROUND

• Facchini 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.

  PMID: 26909063 BACKGROUND

• Fonagy 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.

  PMID: 16210243 BACKGROUND

• Ortuno-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.

  PMID: 29091822 BACKGROUND

• Camoirano 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.

  PMID: 28163690 BACKGROUND

• Eldridge 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.

  PMID: 27965879 BACKGROUND

• Setoya 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.

  PMID: 21453481 BACKGROUND

• Leyton 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.

  PMID: 34717750 DERIVED

• Leyton 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.

  PMID: 31088531 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fanny Leyton, Md

  Hospital Psiquiátrico del Salvador. Universidad de Valparaíso

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist at Child Inpatient Unit, Principal Investigator

Model Details: Participants will be randomized to intervention or control group at a 2:1 ratio

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: December 15, 2017
• Study Start: August 2, 2017
• Primary Completion: January 29, 2019
• Study Completion: April 23, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)