Parenting Clinical Trial
Official title:
Video Feedback Intervention to Enhance Parental Reflective Function in Primary Caregivers of Children With Severe Psychiatric Disorders. Feasibility Randomized Trial
Verified date | April 2019 |
Source | Universidad de Valparaiso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 23, 2019 |
Est. primary completion date | January 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. ) |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Psiquiátrico del Salvador | Valparaíso |
Lead Sponsor | Collaborator |
---|---|
Universidad de Valparaiso | Pontificia Universidad Catolica de Chile, University of Chile |
Chile,
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. — View Citation
Beebe B. Mother-infant research informs mother-infant treatment. Psychoanal Study Child. 2005;60:7-46. — View Citation
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. — View Citation
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. Review. — View Citation
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. eCollection 2016. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Ortuño-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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: Attach Hum Dev. 2014;16(6):656. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | Following completion of the intervention (4 weeks from allocation) | |
Secondary | 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. | Through study completion, approximately 21 months | |
Secondary | 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. | Baseline (T0) | |
Secondary | 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 | Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5) | |
Secondary | 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 | Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5) | |
Secondary | Change over time in Clinical Global Impression Scale (CGAS) in Children | Change in Severity of Psychopathology with Clinical Global Impression Scale (CGAS), | Baseline (T0), weekly during 4 weeks after allocation (T1, T2, T3, T4) and 12 weeks follow up (T5) |
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