Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05798299
Status:
RECRUITING
Last Update Posted:
2023-04-04
First Post:
2023-03-17
Brief Title:
Efficacy Study of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
Sponsor:
University of Lisbon
Organization:
University of Lisbon
Study Overview
Official Title:
Exploratory Randomized Controlled Trial of a Child-centered Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children UP-CC
Status:
RECRUITING
Status Verified Date:
2023-04
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:
UP-CC
Brief Summary:
The UP-C is a manualized cognitive-behavioral and emotion-focused group intervention with a transdiagnostic approach aimed at the treatment of emotional problems ie anxiety and depression in children aged 7 to 12 years old This psychological intervention mainly focuses on reducing the intensity and frequency of strong and aversive emotional experiences in children through the development of skills that allow them to face these emotions in a more adaptive way
By targeting the factors common to emotional disorders avoidance emotional reactivity affective intolerance we believe this intervention might increase the effectiveness of the treatment of these difficulties mainly in the cases where comorbidity is present It may also contribute to therapists expertise when dealing with different emotional disorders by not requiring the simultaneous mastery of multiple interventions to a reduction of costs associated with training and to the planning of more individualized and flexible interventions This approach could help to make interventions suitable for a set of problems more accessible to the public - which is particularly relevant to the Portuguese context Thus to better adapt to the limitations existent in mental health services in Portugal a modified version of the UP-C was developed by reducing the number of sessions for parents
The current study seeks to understand whether this adapted version of the UP-C - the UP-CC - less demanding in terms of resources required for its application is effective in reducing childrens emotional symptomatology and produces changes on maladaptive parenting strategies used by parents This version is mostly centered on the child who participates in 15 90 minutes group sessions In this version of the program the parents adopt the role of cotherapists and support homework completion at home by the child They also have access to psychoeducational material in video and written format Additionally the UP-CC includes three parental sessions that focus on parenting strategies shown to be useful in challenging situations This study also seeks to evaluate child and parent involvement in the intervention and understand its predictors
These are the specific objectives of the study
1 To evaluate the efficacy of the UP-CC through a Randomized Controlled Clinical Trial with two conditions UP-CC and Coping Cat in group format on the primary outcomes childs anxiety and depression symptoms interference of anxiety and depression in the childs school social and family functioning secondary quality of life emotional expression and cognitive errors and on the transdiagnostic factors avoidance emotional reactivity affective intolerance and on the parental variables parents emotional behaviors orientation towards the childs emotions symptoms of anxiety and depression
2 To evaluate the involvement of the child and parents in the program attendance dropout active participation and find out its predictors age intensity of symptoms readiness for change therapeutic alliance expectations regarding the intervention
The main hypothesis of the study relating to the efficacy study is the following
- UP-CC is expected to have equivalent results to Group Coping Cat in outcomes related to anxiety and quality of life and superior results in outcomes related to depression and transdiagnostic mechanisms
By targeting the factors common to emotional disorders avoidance emotional reactivity affective intolerance we believe this intervention might increase the effectiveness of the treatment of these difficulties mainly in the cases where comorbidity is present It may also contribute to therapists expertise when dealing with different emotional disorders by not requiring the simultaneous mastery of multiple interventions to a reduction of costs associated with training and to the planning of more individualized and flexible interventions This approach could help to make interventions suitable for a set of problems more accessible to the public - which is particularly relevant to the Portuguese context Thus to better adapt to the limitations existent in mental health services in Portugal a modified version of the UP-C was developed by reducing the number of sessions for parents
The current study seeks to understand whether this adapted version of the UP-C - the UP-CC - less demanding in terms of resources required for its application is effective in reducing childrens emotional symptomatology and produces changes on maladaptive parenting strategies used by parents This version is mostly centered on the child who participates in 15 90 minutes group sessions In this version of the program the parents adopt the role of cotherapists and support homework completion at home by the child They also have access to psychoeducational material in video and written format Additionally the UP-CC includes three parental sessions that focus on parenting strategies shown to be useful in challenging situations This study also seeks to evaluate child and parent involvement in the intervention and understand its predictors
These are the specific objectives of the study
1 To evaluate the efficacy of the UP-CC through a Randomized Controlled Clinical Trial with two conditions UP-CC and Coping Cat in group format on the primary outcomes childs anxiety and depression symptoms interference of anxiety and depression in the childs school social and family functioning secondary quality of life emotional expression and cognitive errors and on the transdiagnostic factors avoidance emotional reactivity affective intolerance and on the parental variables parents emotional behaviors orientation towards the childs emotions symptoms of anxiety and depression
2 To evaluate the involvement of the child and parents in the program attendance dropout active participation and find out its predictors age intensity of symptoms readiness for change therapeutic alliance expectations regarding the intervention
The main hypothesis of the study relating to the efficacy study is the following
- UP-CC is expected to have equivalent results to Group Coping Cat in outcomes related to anxiety and quality of life and superior results in outcomes related to depression and transdiagnostic mechanisms
Detailed Description:
Participants will be recruited from schools located in Lisbons metropolitan area Portugal The selection of participants will be carried out through a two-phase screening after parental consent and assent from the children are obtained In both phases the children will complete a questionnaire that assesses symptoms of anxiety and depression Children whose score in the screening of anxiety symptoms is in a percentile equal to or greater than 80 will be selected at both assessment times Families of children selected through the screening are invited to an individual assessment session In this session a brief set of questions to parents is asked to ensure their childs eligibility and current difficulties are explored in more detail If the necessary criteria are met the pre-intervention evaluation processes take place child and caregivers complete a set of measures
To access the efficacy of the UP-CC this intervention will be compared with a cognitive-behavioral intervention previously shown to be effective in the treatment of anxiety disorders the Coping Cat program in a group format Thus once the recruitment and evaluation of eligibility criteria is finished the children and their parents will be randomly allocated to one of two conditions
1 experimental group ie children and parents who benefit from the UP-CC program
2 control group ie children who benefit from the Coping Cat group format
In both conditions 1516 weekly sessions with the children will take place in groups of 5 to 7 participants Therapists and childrens manuals are available The groups will be conducted by clinical psychologists integrated in the research team All therapists received training to conduct the intervention and will receive weekly supervision by the project supervisor Every session will be observed and evaluated by an external observer through a checklist
Regarding the primary and secondary outcomes transdiagnostic mechanisms and parental variables the study includes 5 assessment times - at pre-intervention 6 weeks after the start of the intervention after the intervention ends and at two follow-ups 3 and 6 months after the end of the intervention The variables related to the therapeutic process are evaluated at each session active participation assessment of program conduction therapeutic alliance and in the 1st session readiness for change Informed consent from the parents and the children will be sought at each assessment time Consent protocol includes a paragraph that explains how data will be recorded and who has access to it Only information relevant to the study is collected
For the analysis of the effects of the intervention a multivariate analysis of variance MANOVA SPSS 260 will be used To assess participants engagement in the UP-CC data will be collected from all sessions and percentages of attendance and dropout will be calculated ANOVA analysis of variance and Chi-Square tests SPSS 260 will be used to examine differences between the Experimental Group and the Control Group in attendanceactive participation and dropout respectively To explore predictors of attendanceactive participation and dropout Multiple Regressions and Logistic Regressions SPSS 260 will be used respectively
Assuming a mean effect size of 04 on improvement in depressive symptomatology an alpha005 and power08 for a 2-group design with 5 repeated measures the total sample size required is 80 GPower Given an expected dropout of 17 it will be necessary to recruit a minimum of approximately 94 children Thus a sample of 47 children in the experimental group and 47 in the control group is expected 7 UP-CC groups with a maximum number of 7 children will be conducted To allow for a satisfactory number of participants the therapeutic groups will be carried out in two periods March 2023 to July 2023 and October 2024 to February 2024
Missing data due to participants dropout will be handled by intention-to-treat principles estimated using the last observation carried forward LOCF method
To access the efficacy of the UP-CC this intervention will be compared with a cognitive-behavioral intervention previously shown to be effective in the treatment of anxiety disorders the Coping Cat program in a group format Thus once the recruitment and evaluation of eligibility criteria is finished the children and their parents will be randomly allocated to one of two conditions
1 experimental group ie children and parents who benefit from the UP-CC program
2 control group ie children who benefit from the Coping Cat group format
In both conditions 1516 weekly sessions with the children will take place in groups of 5 to 7 participants Therapists and childrens manuals are available The groups will be conducted by clinical psychologists integrated in the research team All therapists received training to conduct the intervention and will receive weekly supervision by the project supervisor Every session will be observed and evaluated by an external observer through a checklist
Regarding the primary and secondary outcomes transdiagnostic mechanisms and parental variables the study includes 5 assessment times - at pre-intervention 6 weeks after the start of the intervention after the intervention ends and at two follow-ups 3 and 6 months after the end of the intervention The variables related to the therapeutic process are evaluated at each session active participation assessment of program conduction therapeutic alliance and in the 1st session readiness for change Informed consent from the parents and the children will be sought at each assessment time Consent protocol includes a paragraph that explains how data will be recorded and who has access to it Only information relevant to the study is collected
For the analysis of the effects of the intervention a multivariate analysis of variance MANOVA SPSS 260 will be used To assess participants engagement in the UP-CC data will be collected from all sessions and percentages of attendance and dropout will be calculated ANOVA analysis of variance and Chi-Square tests SPSS 260 will be used to examine differences between the Experimental Group and the Control Group in attendanceactive participation and dropout respectively To explore predictors of attendanceactive participation and dropout Multiple Regressions and Logistic Regressions SPSS 260 will be used respectively
Assuming a mean effect size of 04 on improvement in depressive symptomatology an alpha005 and power08 for a 2-group design with 5 repeated measures the total sample size required is 80 GPower Given an expected dropout of 17 it will be necessary to recruit a minimum of approximately 94 children Thus a sample of 47 children in the experimental group and 47 in the control group is expected 7 UP-CC groups with a maximum number of 7 children will be conducted To allow for a satisfactory number of participants the therapeutic groups will be carried out in two periods March 2023 to July 2023 and October 2024 to February 2024
Missing data due to participants dropout will be handled by intention-to-treat principles estimated using the last observation carried forward LOCF method
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