Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604988
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Effectiveness of Video-feedback for Positive Parenting with Children At Risk of ASD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Video-feedback to Promote Positive Parenting in Families with Children At Risk of Autism Spectrum Disorder ASD
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIFEPOPA
Brief Summary:
Improving parent-child interactions benefits child development and parents perception of their competencies for childrearing and support for child learning and development which in turns positively impacts on parental emotional well-being and Family Qualiy of Life
This intervention protocol aims to improve the quality of parent-child interactions in daily-routine activities bath time dressing mails specially during play interactions at home increasing the frequency and consistency of the 29 positive parental behaviors included in the PICCOLO PICCOLO is an observational tool for assessing positive parental behaviors in caregiver-child interactions that have been positively related to child cognitive socioemotional and linguistic development It was developed and published in the United States and it was validated in Spain with mothers and fathers An Spanish handbook has been also published
Guiding principles of the intervention protocol are an emphasis on the parents strengths a focus on daily routines in family context and a non-directive intervention style based on video feedback and coaching strategies as self-appraisal and reflection
Although the protocol could be applied to different populations this study is implemented with mothers and fathers with a young child aged 24-36 months at risk of Autism Spectrum Disorder ASD All children and their families are being cared for by professionals in Early Intervention Centers in Spain Inclusion criteria for receiving this intervention are a child at medium-high risk of ASD b primary caregiver at risk of anxiety depression or parental stress c primary caregiver with a low or medium-low level of positive parental behaviors in the PICCOLO
The protocol includes bimonthly sessions of 60 minutes duration for six months with the main caregiver who participates in the program Sessions are conducted by videoconference Every session focuses on three different PICCOLO behaviors that have been identified in a previously recorded caregiver-child interaction during play at home book-reading symbolic play or manipulative play A new video is auto recorded every month by parents so that each video is analyzed together with the caregiver in two sessions After each session the parents receive a written reminder of the aspects that have been worked on in the video feedback session and of the agreements regarding the situations of daily life in which these aspects could be put into practice
Family picture-books are progressively created including selected frames from the videotapes that illustrate the positive parental behaviors that have been discussed Six new images are included every month Caregivers are encouraged to look at and talk about the book with their children at home and to share it with other family members
The primary aim of the proposed study is to assess the efficacy of an intervention to improve caregiver competencies through the observation of caregiver-child interaction using video-feedback coaching strategies based on parental strengths from a collaborative model
It is hypothesized that 1 developmentally supportive parental behaviors of mothers and fathers measured with PICCOLO after the intervention will be significantly higher in the intervention group IG than in the control group CG 2 levels of anxiety or depression andor stress of mothers and fathers after intervention will be significantly lower in the IG than in the CG 3 Parental self-efficacy of mothers and fathers after the intervention will be significantly higher in the IG than in the CG and 4 family quality of life after intervention will be significantly higher in the IG than in the CG Also it is hypothesized that individual trajectories in families within the IG will show changes in the outcome variables consistent with these expectations during the intervention period it is hypothesized that these positive changes will not be observed in the CG who will continue receiving the usual early intervention services
With respect to intervention assessment it is hypothesized that there will be significant and positive associations between key outcomes of the study and the scores obtained on the HOVRS-3 measure of four evidence-based home visiting practices relationship building with families responsiveness to family strengths facilitating family interaction collaboration with caregivers
Finally it is expected to find a secondary benefit on childs development assessed with the DP-3 Developmental Profile-3 particularly in the communication and social adaptation areas
This intervention protocol aims to improve the quality of parent-child interactions in daily-routine activities bath time dressing mails specially during play interactions at home increasing the frequency and consistency of the 29 positive parental behaviors included in the PICCOLO PICCOLO is an observational tool for assessing positive parental behaviors in caregiver-child interactions that have been positively related to child cognitive socioemotional and linguistic development It was developed and published in the United States and it was validated in Spain with mothers and fathers An Spanish handbook has been also published
Guiding principles of the intervention protocol are an emphasis on the parents strengths a focus on daily routines in family context and a non-directive intervention style based on video feedback and coaching strategies as self-appraisal and reflection
Although the protocol could be applied to different populations this study is implemented with mothers and fathers with a young child aged 24-36 months at risk of Autism Spectrum Disorder ASD All children and their families are being cared for by professionals in Early Intervention Centers in Spain Inclusion criteria for receiving this intervention are a child at medium-high risk of ASD b primary caregiver at risk of anxiety depression or parental stress c primary caregiver with a low or medium-low level of positive parental behaviors in the PICCOLO
The protocol includes bimonthly sessions of 60 minutes duration for six months with the main caregiver who participates in the program Sessions are conducted by videoconference Every session focuses on three different PICCOLO behaviors that have been identified in a previously recorded caregiver-child interaction during play at home book-reading symbolic play or manipulative play A new video is auto recorded every month by parents so that each video is analyzed together with the caregiver in two sessions After each session the parents receive a written reminder of the aspects that have been worked on in the video feedback session and of the agreements regarding the situations of daily life in which these aspects could be put into practice
Family picture-books are progressively created including selected frames from the videotapes that illustrate the positive parental behaviors that have been discussed Six new images are included every month Caregivers are encouraged to look at and talk about the book with their children at home and to share it with other family members
The primary aim of the proposed study is to assess the efficacy of an intervention to improve caregiver competencies through the observation of caregiver-child interaction using video-feedback coaching strategies based on parental strengths from a collaborative model
It is hypothesized that 1 developmentally supportive parental behaviors of mothers and fathers measured with PICCOLO after the intervention will be significantly higher in the intervention group IG than in the control group CG 2 levels of anxiety or depression andor stress of mothers and fathers after intervention will be significantly lower in the IG than in the CG 3 Parental self-efficacy of mothers and fathers after the intervention will be significantly higher in the IG than in the CG and 4 family quality of life after intervention will be significantly higher in the IG than in the CG Also it is hypothesized that individual trajectories in families within the IG will show changes in the outcome variables consistent with these expectations during the intervention period it is hypothesized that these positive changes will not be observed in the CG who will continue receiving the usual early intervention services
With respect to intervention assessment it is hypothesized that there will be significant and positive associations between key outcomes of the study and the scores obtained on the HOVRS-3 measure of four evidence-based home visiting practices relationship building with families responsiveness to family strengths facilitating family interaction collaboration with caregivers
Finally it is expected to find a secondary benefit on childs development assessed with the DP-3 Developmental Profile-3 particularly in the communication and social adaptation areas
Detailed Description:
The main objective of the study is to analyze the efficacy of a video feedback intervention in a group of mothers and fathers with children at risk of autism spectrum disorders ASD The interventions impact on four variables will be assessed parenting 1 the emotional distress of mothers and fathers anxiety depression and stress 2 parental self-efficacy 3 and family quality of life 4 The differential change in individual trajectories will be analyzed for the four variables based on belonging to the experimental group The aim is to develop an intervention guide for the use of coaching strategies based on observation and video feedback
Participants in the study will be 60 families comprised of a main caregiver mother or father of a child at risk of ASD between 24 and 36 months of age with adequate internet access who will be recruited from early intervention centers in Spain The inclusion criteria are a the children have M-Chat scores compatible with medium-high risk of ASD scores equal to or greater than 8 b the main caregiver has high scores in at least one of the following variables b1 anxiety quantified using the HADS scale scores equal to or greater than 7 b2 depression quantified using the HADS scale scores equal to or greater than 7 b3 stress measured using the stress dimension of the PSI-F tool scores equal to or greater than 86 c the main caregiver has low parenting scores quantified by the total score on the PICCOLO an observational tool to score parental behaviors that support child development score equal to or less than 40 The exclusion criteria are that the family a is currently receiving or has received in the last 12 months an intervention to improve parental interactions similar to the one proposed in this project or protocol b does not have a good level of written and spoken Spanish or c has mental health problems or children with serious physical problems or multiple disabilities
The 60 families that meet the inclusion criteria will be randomly distributed into two groups of 30 families intervention group and control group
All the participants both in the intervention group and the control group will answer the questionnaires on emotional distress anxiety depression and parental stress parental self-efficacy and family quality of life before and after the intervention Child development will be evaluated before and after the intervention with the DP-3 instrument Families will make an audiovisual recording of 10 minutes of play interaction at home with their child under the conditions to which we will refer later
For all the cases in the intervention group the same protocol will be followed which combines coaching strategies based on observation and video feedback
Biweekly sessions will be conducted for 6 months a total of 12 sessions per family via videoconference with the family at home Each session will last approximately between 1 hour and 1 hour 30 minutes and it will work with the main caregiver following the following procedure
Before the first session the family is asked to record a 10-minute video of play interaction with their child at home in relation to three possible situations i reading books ii symbolic or fictional play or iii manipulative games for example puzzles and shape fitting using their own materials or games to be evaluated with PICCOLO The analysis of this video recording assesses compliance with the inclusion criteria that refer to parental behaviors
PICCOLO is an observational tool made up of 29 items that correspond to 29 developmental support parenting behaviors organized into four subscales or domains affection responsiveness encouragement teaching The recording of a new video will be requested every two sessions that is at end of the evenly numbered sessions 2 4 6 etc Thus each audiovisual record will be worked on during two sessions
Before the first intervention session a preliminary or reception session will be held In this session the first contact with the caregiver will be established to find out their concerns interests and needs to share with himher what PICCOLO is with an emphasis on positive parental behaviors and how these behaviors benefit and promote child development and to explain the intervention procedure to the family The main caregiver will be told that the focus of the intervention is positive parental behaviors observed in the videos and that in the sessions we will talk to the caregivers about these behaviors The caregiver will be informed that in the first intervention session we will have seen the video that she sent us and we will focus on discussing some aspects of the interaction with her son or daughter In the final part of this first reception session the DP-3 development scale will be applied in an interview format approximately 20 minutes with the aim of collecting data about the childs development It will be explained to the caregiver that collecting this information about the development of her son or daughter will help us to get to know him or her a little better This scale of development is designed to be able to be applied virtually in an interview format with the main caregiver
The procedure that will be followed in the other intervention sessions is as follows
Each session will focus on three parental behaviors that support child development that have appeared clearly frequently and consistently in the video PICCOLO score of 2 in any of the 4 dimensions affection responsiveness encouragement teaching Other aspects of parental behaviors that have scored 1 or 0 on the PICCOLO will also be taken into account to increase their frequency or encourage their appearance It is to be expected that all the behaviors collected in PICCOLO appear in one or more of the recordings even if only occasionally Behaviors that do not appear can be introduced through linking strategies with other behaviors in which parents show strength for example if a caregiver tends to name objects a lot a link can be established between naming and asking the child the name of objects if questions are behavior that does not appear in the logs
In each session the caregiver is shown video clips that clearly show the positive parenting behaviors and how they relate to what the child is doing to give the primary caregiver the opportunity to observe themselves performing a positive parenting strategy or behavior It is important to provide reflective feedback to caregivers To give feedback to caregivers we will choose three of the parenting behaviors and give the following message to parents
When I watched the video I noticed that you what the parent did and thats PICCOLO item label in the PICCOLO domain name domain and I noticed how the child responded and that helps your childs development because how it helps the childs development Lets talk about other times when you do these things and how you might be able to do them more often Giving feedback with PICCOLO is simple if we plan our feedback focusing on three strong PICCOLO behaviours
It is also important to give parents reflective feedback We could use the following questions
What do you think of this behaviour that we have been discussing Had you noticed this Do you think you could continue to do this Continue to ask questions based on the caregivers responses and link them to the needs andor concerns expressed by the family and to the childs development
At what other times do you think you could do what we have discussed family routinesHow do you think you could do this At the end of the session we will close it with a brief summary of what was discussed and make an appointment for the next session
At the end of the session the intervener designs in collaboration with the parents an individualized biweekly family support programme PIAFQ in which they specify what other parental behaviours they can continue to carry out at home in their daily routines to promote the development of their children before the next intervention session
The PIAFQ will be prepared in writing and sent to parents by email In each session the objectives of the previous fortnightly plan and how they have been carried out at home will be reviewed with the main caregiver Doubts needs and concerns of the caregiver will be addressed These will vary for each child and family
In addition every two sessions the caregiver will be provided with visual support for the video feedback sessions in a book with pictures or images taken from the audiovisual records electronic book e-book or a PowerPoint or PDF document
Each page of the book will illustrate a parenting behavior that supports development and corresponds with an item of the PICCOLO The image will be accompanied by a brief description of the parental behavior and its relationship with child development in simple and direct language as if the participants were speaking You can include a footer for example I love that my mom plays with me what I want to play or I like to encourage my son when he is struggling to fit the pieces in balloons typical of comics for example the mother says I am happy when my daughter say a word or two and I can repeat what she says Yum this soup is good In addition include some reference on the benefits for the childs development for example and it helps me to learn words or it makes me feel safe
This picture book will be sent to parents along with the biweekly plan Parents are encouraged to read the book with their child between video feedback visits and to share it with other caregivers andor family members of the child This strategy has been used successfully in other studies to reinforce positive aspects of the interaction between the mother or the mother and her child The intervention will be carried out by specialized professionals who are trained in video feedback by the main researchers of the project Six months from the end of the intervention follow-up measurements of all the study variables will be made in the intervention group and the control group
Participants in the study will be 60 families comprised of a main caregiver mother or father of a child at risk of ASD between 24 and 36 months of age with adequate internet access who will be recruited from early intervention centers in Spain The inclusion criteria are a the children have M-Chat scores compatible with medium-high risk of ASD scores equal to or greater than 8 b the main caregiver has high scores in at least one of the following variables b1 anxiety quantified using the HADS scale scores equal to or greater than 7 b2 depression quantified using the HADS scale scores equal to or greater than 7 b3 stress measured using the stress dimension of the PSI-F tool scores equal to or greater than 86 c the main caregiver has low parenting scores quantified by the total score on the PICCOLO an observational tool to score parental behaviors that support child development score equal to or less than 40 The exclusion criteria are that the family a is currently receiving or has received in the last 12 months an intervention to improve parental interactions similar to the one proposed in this project or protocol b does not have a good level of written and spoken Spanish or c has mental health problems or children with serious physical problems or multiple disabilities
The 60 families that meet the inclusion criteria will be randomly distributed into two groups of 30 families intervention group and control group
All the participants both in the intervention group and the control group will answer the questionnaires on emotional distress anxiety depression and parental stress parental self-efficacy and family quality of life before and after the intervention Child development will be evaluated before and after the intervention with the DP-3 instrument Families will make an audiovisual recording of 10 minutes of play interaction at home with their child under the conditions to which we will refer later
For all the cases in the intervention group the same protocol will be followed which combines coaching strategies based on observation and video feedback
Biweekly sessions will be conducted for 6 months a total of 12 sessions per family via videoconference with the family at home Each session will last approximately between 1 hour and 1 hour 30 minutes and it will work with the main caregiver following the following procedure
Before the first session the family is asked to record a 10-minute video of play interaction with their child at home in relation to three possible situations i reading books ii symbolic or fictional play or iii manipulative games for example puzzles and shape fitting using their own materials or games to be evaluated with PICCOLO The analysis of this video recording assesses compliance with the inclusion criteria that refer to parental behaviors
PICCOLO is an observational tool made up of 29 items that correspond to 29 developmental support parenting behaviors organized into four subscales or domains affection responsiveness encouragement teaching The recording of a new video will be requested every two sessions that is at end of the evenly numbered sessions 2 4 6 etc Thus each audiovisual record will be worked on during two sessions
Before the first intervention session a preliminary or reception session will be held In this session the first contact with the caregiver will be established to find out their concerns interests and needs to share with himher what PICCOLO is with an emphasis on positive parental behaviors and how these behaviors benefit and promote child development and to explain the intervention procedure to the family The main caregiver will be told that the focus of the intervention is positive parental behaviors observed in the videos and that in the sessions we will talk to the caregivers about these behaviors The caregiver will be informed that in the first intervention session we will have seen the video that she sent us and we will focus on discussing some aspects of the interaction with her son or daughter In the final part of this first reception session the DP-3 development scale will be applied in an interview format approximately 20 minutes with the aim of collecting data about the childs development It will be explained to the caregiver that collecting this information about the development of her son or daughter will help us to get to know him or her a little better This scale of development is designed to be able to be applied virtually in an interview format with the main caregiver
The procedure that will be followed in the other intervention sessions is as follows
Each session will focus on three parental behaviors that support child development that have appeared clearly frequently and consistently in the video PICCOLO score of 2 in any of the 4 dimensions affection responsiveness encouragement teaching Other aspects of parental behaviors that have scored 1 or 0 on the PICCOLO will also be taken into account to increase their frequency or encourage their appearance It is to be expected that all the behaviors collected in PICCOLO appear in one or more of the recordings even if only occasionally Behaviors that do not appear can be introduced through linking strategies with other behaviors in which parents show strength for example if a caregiver tends to name objects a lot a link can be established between naming and asking the child the name of objects if questions are behavior that does not appear in the logs
In each session the caregiver is shown video clips that clearly show the positive parenting behaviors and how they relate to what the child is doing to give the primary caregiver the opportunity to observe themselves performing a positive parenting strategy or behavior It is important to provide reflective feedback to caregivers To give feedback to caregivers we will choose three of the parenting behaviors and give the following message to parents
When I watched the video I noticed that you what the parent did and thats PICCOLO item label in the PICCOLO domain name domain and I noticed how the child responded and that helps your childs development because how it helps the childs development Lets talk about other times when you do these things and how you might be able to do them more often Giving feedback with PICCOLO is simple if we plan our feedback focusing on three strong PICCOLO behaviours
It is also important to give parents reflective feedback We could use the following questions
What do you think of this behaviour that we have been discussing Had you noticed this Do you think you could continue to do this Continue to ask questions based on the caregivers responses and link them to the needs andor concerns expressed by the family and to the childs development
At what other times do you think you could do what we have discussed family routinesHow do you think you could do this At the end of the session we will close it with a brief summary of what was discussed and make an appointment for the next session
At the end of the session the intervener designs in collaboration with the parents an individualized biweekly family support programme PIAFQ in which they specify what other parental behaviours they can continue to carry out at home in their daily routines to promote the development of their children before the next intervention session
The PIAFQ will be prepared in writing and sent to parents by email In each session the objectives of the previous fortnightly plan and how they have been carried out at home will be reviewed with the main caregiver Doubts needs and concerns of the caregiver will be addressed These will vary for each child and family
In addition every two sessions the caregiver will be provided with visual support for the video feedback sessions in a book with pictures or images taken from the audiovisual records electronic book e-book or a PowerPoint or PDF document
Each page of the book will illustrate a parenting behavior that supports development and corresponds with an item of the PICCOLO The image will be accompanied by a brief description of the parental behavior and its relationship with child development in simple and direct language as if the participants were speaking You can include a footer for example I love that my mom plays with me what I want to play or I like to encourage my son when he is struggling to fit the pieces in balloons typical of comics for example the mother says I am happy when my daughter say a word or two and I can repeat what she says Yum this soup is good In addition include some reference on the benefits for the childs development for example and it helps me to learn words or it makes me feel safe
This picture book will be sent to parents along with the biweekly plan Parents are encouraged to read the book with their child between video feedback visits and to share it with other caregivers andor family members of the child This strategy has been used successfully in other studies to reinforce positive aspects of the interaction between the mother or the mother and her child The intervention will be carried out by specialized professionals who are trained in video feedback by the main researchers of the project Six months from the end of the intervention follow-up measurements of all the study variables will be made in the intervention group and the control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None