Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303791
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-04
Brief Title:
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
Official Title:
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders a Randomized Control Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INPSYD
Brief Summary:
The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support randomized and with a control group that will be conducted virtually and synchronously to families of children with autism spectrum disorder ASD and families of children with Attention Deficit with hyperactivity Disorder ADHD The main questions it aims to answer are
1 Will the program impact on different variables in the parents domain parental stress variables quality of lifesocial support and coping skills
2 Will the program impact on different variables in the childrens domain daily life functioning social behavioral variables and executive functioning
3 Treatment outcomes will be assessed at pre-test post-test and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress coping skills social support and childrens dysfunctional outcomes
Parents and teachers will complete different questionnaires to see if there are improvements on parents and children outcomes
Researchers will compare intervention group and control group to see if there are improvements on parents domains parenting stress coping skills social support and childrens dysfunctional outcomes daily life functioning social behavioral variables and executive functioning
1 Will the program impact on different variables in the parents domain parental stress variables quality of lifesocial support and coping skills
2 Will the program impact on different variables in the childrens domain daily life functioning social behavioral variables and executive functioning
3 Treatment outcomes will be assessed at pre-test post-test and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress coping skills social support and childrens dysfunctional outcomes
Parents and teachers will complete different questionnaires to see if there are improvements on parents and children outcomes
Researchers will compare intervention group and control group to see if there are improvements on parents domains parenting stress coping skills social support and childrens dysfunctional outcomes daily life functioning social behavioral variables and executive functioning
Detailed Description:
AIMS The goal of this clinical trial is to implement a structured psychosocial intervention program with digital support randomized and with a control group that will be conducted virtually and synchronously to families of children with autism spectrum disorder ASD and families of children with Attention Deficit with hyperactivity Disorder ADHD
The specific aims of this study are
1 to analyze whether a digital-based psychosocial program for parents of children with ASD and children with ADHD leads to an improvement of parents outcomes level of stress coping skills and perceived social support in comparison with an active control group
2 to examine whether a digital-based psychosocial program for parents of children with ASD and children with ADHD will lead to improvement of children outcomes such as social difficulties daily executive disfunctions and sleep or learning problems in comparison with an active control group
3 Treatment outcomes will be assessed at pre-test post-test and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress coping skills social support and childrens dysfunctional outcomes
METHODOLOGY
Design
The basic research design is a randomized controlled design observing the recommendations made by Jadad and Enkin 2007 To test the proposed objectives a mixed design will be used with a between-groups factor type of therapy and a intra-groups with pre-treatment T0 post-treatment T1 and follow-up measurements at 6 months T2 Participants will be randomly assigned 11 to the two conditions a group that will receive the intervention of the structured psychosocial program with digital support experimental group and a control group The experimental group will undergo an evaluation prior to the intervention one immediately after it and a third follow-up evaluation In the case of the control group it will be evaluated through the pretest phases posttest and follow-up
Participants
The present study enrolled 90 families of boys and girls with ASD without intellectual disabilities and ADHD with an age range between 7 and 11 years 47 children with ASD without intellectual disabilities and 43 children with ADHD The children were recruited from specialized psychoeducational centers and medical centers in Spain Informed consent will be requested from parents
Sample size was calculated using a priori Sample Size Calculator for one-way ANOVA using Gpower v 3194 setting the size of Type I error significance level of 005 a and the power of the study of the 80 anticipating an effect size Cohen d of 08
Instruments
Parents and teachers will complete different questionnaires to see if there are improvements on parents domains and childrens dysfunctional outcomes
Researchers will compare intervention group and control group to see if there are improvements on parents domains and childrens dysfunctional outcomes
Procedure
The study was approved by the Ethics Committee of the Universitat de València in accordance with the principles of Helsinki Declaration World Medical Association2013 UV-INV_ETICA-1905517 The tests were applied by psychologists who were familiar with the use of the different instruments The parents provided their written informed consent in addition to the oral consent of all the children who participated This study was supported by the Spanish project PID2021-128044NA-100 Ministerio de Ciencia e InnovacionAEIFEDER UE
Familieschildren who meet the inclusion criteria will be randomly assigned to one of the two conditions intervention group or control group using a controlled design Block randomization will be applied to each of the diagnostic groups ASD ADHD to ensure that the participants were of approximately similar size 11 ratio in the treatment and control conditions After determining the size of each block in the sample ASD and ADHD the treatment allocation of each individual participant will be done randomlyA blind procedure will be used participating families will not know the group to which the participants will be assigned and the researchers who will collect and enter the data will also have no knowledge of the condition to which the families will be assigned
The intervention program as well as the evaluation will be carried out by an expert psychologist in neurodevelopmental disorders The psychosocial program with digital support has been developed by combining different theoretical perspectives on intervention in children with ASD without intellectual disabilities and children with ADHD The contents of the program are based on three main approaches each of which has separately demonstrated evidence in the treatment of these neurodevelopmental disorders psychoeducation and stress management cognitive behavioral techniques and techniques in social and communication skills Dahl et al 2020 DuPaul et al 2020 Tan-MacNeill et al 2021
The intervention sessions with parents will be carried out in a synchronous virtual mode with the aim of achieving maximum adherence to the program and overcoming logistical barriers of physical distances and the problems of coping with work and care The sessions will be in small groups to adapt to these needs Specifically the psychosocial intervention group will be made up of five successive groups of 8 to 10 families that will receive 12 weekly 90-minute sessions
The integrity of the sessions will be guaranteed by a digital manual that clearly outlined all the procedures to be used in the intervention Additionally sessions will be audiotaped and reviewed by a team member through a checklist to ensure groups receive equivalent set of information
The control group of parents will be made up of another five successive groups of 8 to 10 families who will receive 12 sessions weekly 90 minutes In these sessions these families will be encouraged to discuss their thoughts and share their experiences in a non-directive environment The therapist will not be allowed to provide specific psychotherapy psychoeducation or psychosocial techniques nor any additional comments or information but rather to guide the groups and allow everyone to express and give their personal point of view The use of an active control group will ensure that the observed benefits are primarily due to the digitally supported psychosocial program only
Both groups will have the same conditions at baseline and the sessions will be carried out by the same therapist in both groups Likewise another person from the research team will verify the integrity of the program
The pre- and post-test evaluation of the parents will be carried out in person individually in a meeting room of the Faculty of Psychology of University of Valencia Likewise before the first intervention session parents will be provided with a tutorial on the video conferencing platform Zoom wwwzoomus to familiarize with the software and minimize potential risks Parents will be able to participate in the program from home or another location as long as parents have an internet connection using a tablet computer or smartphone with a webcam Zoom has been chosen because it can host online group meetings without an annual commitment unlike other types of software Zoom is has been used successfully in health research Participants can access meetings without having to purchase or install software through any device Participants will be able to access the meetings online through a hyperlink or log in the ID and password that will be provided to the participants and to enter the session
Continuous contact will be maintained via telephone and virtual with families to provide an immediate response to any difficulty that may arise in the intervention process
The Structure of a typical session 90mn in experimental group would be
Welcome questions doubts previous session
Theoretical explanation on the topic of the session
Modeling and roll-playing videos on the contents explained eg cognitive techniques andor relaxation techniques
Proposal of activities for the week based on the contents explained in each session
Questionnaire of questions about content and satisfaction with the session
Plan for missing data
The investigators will use different statistical methods to deal with missing data specifically participants with any missing data will be excluded from analysis or the investigators will use a simple mean imputation being very cautious not to bias the method
Statistical analysis
Statistical analyzes will be carried out based on the objectives set trying to control the contaminating effects as much as possible
Preliminary analyzes will be carried out Kolmogorov-Smirnov test to confirm the assumptions of normality maintained between the different variables Non-parametric or parametric tests will be applied depending on whether the criteria to perform the tests are met
For intragroup comparisons repeated measures ANOVAs will be run to evaluate the change in the preposttest results and in the follow-up six months later Descriptive statistics will be calculated and other statistics will be applied eg Mann-Whitney U statistic for comparison between experimental groups performing moderation analysis with the conceptually indicated variables Effect sizes will be calculated using partial eta squared values according to Cohen 1988 an eta squared 006 small 006-014 medium 014 large Statistical analyzes will be carried out with the SPSS v statistical package 240
The specific aims of this study are
1 to analyze whether a digital-based psychosocial program for parents of children with ASD and children with ADHD leads to an improvement of parents outcomes level of stress coping skills and perceived social support in comparison with an active control group
2 to examine whether a digital-based psychosocial program for parents of children with ASD and children with ADHD will lead to improvement of children outcomes such as social difficulties daily executive disfunctions and sleep or learning problems in comparison with an active control group
3 Treatment outcomes will be assessed at pre-test post-test and 6-month follow-up assessment across intervention and control groups using a battery of measures of parenting stress coping skills social support and childrens dysfunctional outcomes
METHODOLOGY
Design
The basic research design is a randomized controlled design observing the recommendations made by Jadad and Enkin 2007 To test the proposed objectives a mixed design will be used with a between-groups factor type of therapy and a intra-groups with pre-treatment T0 post-treatment T1 and follow-up measurements at 6 months T2 Participants will be randomly assigned 11 to the two conditions a group that will receive the intervention of the structured psychosocial program with digital support experimental group and a control group The experimental group will undergo an evaluation prior to the intervention one immediately after it and a third follow-up evaluation In the case of the control group it will be evaluated through the pretest phases posttest and follow-up
Participants
The present study enrolled 90 families of boys and girls with ASD without intellectual disabilities and ADHD with an age range between 7 and 11 years 47 children with ASD without intellectual disabilities and 43 children with ADHD The children were recruited from specialized psychoeducational centers and medical centers in Spain Informed consent will be requested from parents
Sample size was calculated using a priori Sample Size Calculator for one-way ANOVA using Gpower v 3194 setting the size of Type I error significance level of 005 a and the power of the study of the 80 anticipating an effect size Cohen d of 08
Instruments
Parents and teachers will complete different questionnaires to see if there are improvements on parents domains and childrens dysfunctional outcomes
Researchers will compare intervention group and control group to see if there are improvements on parents domains and childrens dysfunctional outcomes
Procedure
The study was approved by the Ethics Committee of the Universitat de València in accordance with the principles of Helsinki Declaration World Medical Association2013 UV-INV_ETICA-1905517 The tests were applied by psychologists who were familiar with the use of the different instruments The parents provided their written informed consent in addition to the oral consent of all the children who participated This study was supported by the Spanish project PID2021-128044NA-100 Ministerio de Ciencia e InnovacionAEIFEDER UE
Familieschildren who meet the inclusion criteria will be randomly assigned to one of the two conditions intervention group or control group using a controlled design Block randomization will be applied to each of the diagnostic groups ASD ADHD to ensure that the participants were of approximately similar size 11 ratio in the treatment and control conditions After determining the size of each block in the sample ASD and ADHD the treatment allocation of each individual participant will be done randomlyA blind procedure will be used participating families will not know the group to which the participants will be assigned and the researchers who will collect and enter the data will also have no knowledge of the condition to which the families will be assigned
The intervention program as well as the evaluation will be carried out by an expert psychologist in neurodevelopmental disorders The psychosocial program with digital support has been developed by combining different theoretical perspectives on intervention in children with ASD without intellectual disabilities and children with ADHD The contents of the program are based on three main approaches each of which has separately demonstrated evidence in the treatment of these neurodevelopmental disorders psychoeducation and stress management cognitive behavioral techniques and techniques in social and communication skills Dahl et al 2020 DuPaul et al 2020 Tan-MacNeill et al 2021
The intervention sessions with parents will be carried out in a synchronous virtual mode with the aim of achieving maximum adherence to the program and overcoming logistical barriers of physical distances and the problems of coping with work and care The sessions will be in small groups to adapt to these needs Specifically the psychosocial intervention group will be made up of five successive groups of 8 to 10 families that will receive 12 weekly 90-minute sessions
The integrity of the sessions will be guaranteed by a digital manual that clearly outlined all the procedures to be used in the intervention Additionally sessions will be audiotaped and reviewed by a team member through a checklist to ensure groups receive equivalent set of information
The control group of parents will be made up of another five successive groups of 8 to 10 families who will receive 12 sessions weekly 90 minutes In these sessions these families will be encouraged to discuss their thoughts and share their experiences in a non-directive environment The therapist will not be allowed to provide specific psychotherapy psychoeducation or psychosocial techniques nor any additional comments or information but rather to guide the groups and allow everyone to express and give their personal point of view The use of an active control group will ensure that the observed benefits are primarily due to the digitally supported psychosocial program only
Both groups will have the same conditions at baseline and the sessions will be carried out by the same therapist in both groups Likewise another person from the research team will verify the integrity of the program
The pre- and post-test evaluation of the parents will be carried out in person individually in a meeting room of the Faculty of Psychology of University of Valencia Likewise before the first intervention session parents will be provided with a tutorial on the video conferencing platform Zoom wwwzoomus to familiarize with the software and minimize potential risks Parents will be able to participate in the program from home or another location as long as parents have an internet connection using a tablet computer or smartphone with a webcam Zoom has been chosen because it can host online group meetings without an annual commitment unlike other types of software Zoom is has been used successfully in health research Participants can access meetings without having to purchase or install software through any device Participants will be able to access the meetings online through a hyperlink or log in the ID and password that will be provided to the participants and to enter the session
Continuous contact will be maintained via telephone and virtual with families to provide an immediate response to any difficulty that may arise in the intervention process
The Structure of a typical session 90mn in experimental group would be
Welcome questions doubts previous session
Theoretical explanation on the topic of the session
Modeling and roll-playing videos on the contents explained eg cognitive techniques andor relaxation techniques
Proposal of activities for the week based on the contents explained in each session
Questionnaire of questions about content and satisfaction with the session
Plan for missing data
The investigators will use different statistical methods to deal with missing data specifically participants with any missing data will be excluded from analysis or the investigators will use a simple mean imputation being very cautious not to bias the method
Statistical analysis
Statistical analyzes will be carried out based on the objectives set trying to control the contaminating effects as much as possible
Preliminary analyzes will be carried out Kolmogorov-Smirnov test to confirm the assumptions of normality maintained between the different variables Non-parametric or parametric tests will be applied depending on whether the criteria to perform the tests are met
For intragroup comparisons repeated measures ANOVAs will be run to evaluate the change in the preposttest results and in the follow-up six months later Descriptive statistics will be calculated and other statistics will be applied eg Mann-Whitney U statistic for comparison between experimental groups performing moderation analysis with the conceptually indicated variables Effect sizes will be calculated using partial eta squared values according to Cohen 1988 an eta squared 006 small 006-014 medium 014 large Statistical analyzes will be carried out with the SPSS v statistical package 240
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None