Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366438
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2024-04-09
Brief Title:
A Trial of Two Universal Programs for Parents of Teenagers
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
A Randomized Controlled Trial of Two Universal Programs for Parents of Teenagers ABC Face-to-face vs Parentweb Online
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
Parent training programs in groups and over internet can help parents improve their interaction and communication with their children There is however a lack knowledge of how programs work for parents of teenagers as most studies have concerned younger children Furthermore most studies have been conducted on programs for selective populations with elevated risk The aim of this study was to investigate the effectiveness of two universal preventive parenting programs for teenagers The group-based program ABC-teen and the online-based ParentWeb Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication The programs are developed in Sweden with content based on other established parenting programs eg Comet Incredible Years the Triple P The aim of the present study was to evaluate the effects of the the two programs with adolescent mental health as primary outcome Several secondary outcome measures concerning parenting and parent-adolescent relationship were also collected Parents were randomized to ABC-teen ParentWeb or a 6 months Wait-List control Parent- and adolescent ratings were collected at baseline after 4 and after 12 months All data collection has now been completed and the next step is to process and analyze the data
Detailed Description:
BACKGROUND
Despite the development of psychological treatments in recent decades mental health disorders remain a main cause of disease functional impairments and deaths of adolescents across the world UNICEF estimated that globally over 13 percent of adolescents 10-19 live with a mental disorder Moreover suicide is the fifth most common cause of death for adolescents in the same age-span and the fourth most prevalent cause for adolescents 15-19 years old Reports also show that youth mental illness have increased in recent years Psychological treatments seems not enough to combat this negative development preventive efforts are needed
Family experiences can be a target of prevention given the strong impact on young peoples current and future mental health The quality of the parent-child relationship impacts health quality throughout life Also adverse experiences related to family and parenting dysfunction is one of the main predictors of mental ill-health While adolescence is a period of increased independence parents remain one of the most important people in the young persons life A link between parenting factors during adolescence and anxiety and depression which constitutes 40 of diagnosed adolescent mental disorders is established Parenting factors linked to depression and anxiety include low warmth inter-parental conflict over-involvement and aversiveness
Decades of research support the health benefits of parent training programs that help parents interact and communicate with their children including face-to-face programs delivered in groups and internet-based programs However most studies have concerned children below 13 years of age Given the impact of parenting factors during adolescence on mental health it is important to investigate how parenting programs work for parents of adolescents
Parenting programs on different prevention levels are needed to maximize the benefit on public health However most studies have concerned indicatedselected prevention or treatments Outcomes have mostly concerned symptom reduction To prevent health problems at a population scale more studies are needed of how parenting programs benefit the general population ie universal prevention The general population includes those who do not presently experience clinical problems but where future issues may be prevented through strengthening health-promoting factors eg family relationships
PURPOSE AND RESEARCH QUESTIONS
The aim of this study is to assess the effectiveness of two universal preventive parenting programs for teenagers ABC-teen and ParentWeb A version of the ABC program for children 3-12 years old has been evaluated in a randomized controlled trial but so far no study has investigated ABC-teen Likewise a longer version of the ParentWeb targeting a selected group of parents with elevated levels of conflict with their adolescents has been published but no study on the universal version of ParentWeb The effects of the programs will be evaluated both in comparison to each other and to a Wait-List control Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication
1 What are the programs effect on adolescent and parental mental health
2 What are the programs effect on parenting behaviors and parental self-efficacy
3 What are the programs effect on the relationship between parents and adolescents
4 What are the programs effect on school adjustment
5 What are the programs effect on the adolescents use of tobacco alcohol and drugs
6 To what extent do the parents experience participation in the programs as feasible and satisfying
Research question 1-6 will be reported in the main paper from the project while the following research questions will be reported in following papers
7 Are there predictors and moderators of program effects eg demographic variables and variables related to implementationadherence
8 What are the health economic outcomes of the programs
METHOD
Participants
The sample consisted of 1247 families 1327 parents and 471 adolescents from the general population from 58 sites in 52 municipalities across Sweden The participants were recruited through local advertisements in schools or online municipality channels Parents who were interested were referred to a website with additional information and a consent form All members in a family parents and adolescents were invited to contribute to the data collection in the study questionnaires
Design
The study is a multi-site randomized controlled trial Parents were randomized to ABC-teen ParentWeb or a 6 months Wait-List control After recruitment participants responded to baseline measurements and were subsequently randomized to one of the three study conditions The randomization was conducted centrally by the researchers but with separate randomization list for each site generated at randomizeorg The researchers then informed a local coordinator at the site about participants allocation Parents and adolescents who were included at baseline were invited to answer follow-up questionnaires after 4 and 12 months The wait-list control group parents were invited to participate in either ABC-teen or ParentWeb their choice after 6 months Thus at the 12 month follow-up analyses of program effects will be restricted to comparisons between the programs
Sample size calculation
As the effects of universal interventions are generally small a relatively large study group was required for adequate statistical power also considering that drop-out can be substantial in multi-site studies For a statistical power of 80 200 participating families will be needed to detect small differences in effect size Cohens d 20 with alpha 005 Since the randomization was unbalanced 2-1-1 in ABC-teen ParentWeb and wait list an additional 200 families had to be recruited to reach at least 200 in each condition ie 400 in ABC-teen 200 in ParentWeb and 200 in the wait list This means that a total of 800 families with complete data were needed for the study To account for dropout an additional 447 families were recruited Actual ns in each condition at each measurement point were as follows at the completion of data collection ABC-teen - 669 baseline 520 4 month 458 12 month ParentWeb - 297 baseline 209 4 month 168 12 month Wait list - 281 baseline 210 4 month
Statistical analyses
Linear Mixed Modeling LMM will be used for analyzing the effects of the programs questions 1-5 in two steps First effects at 4 month will be analyzed comparing each of the program to the wait list control Second the two programs will be compared to each other at 4 and 12 month For questions 6 t-tests will be conducted to investigate mean differences between the two program conditions For question 7 LMM-analyses will be conducted with predictors and moderators entered into the equations to test if they have differential effects on the slope of adolescent mental health and parenting variables from baseline to 12 month follow-up For question 8 two different health economic analyses will be conducted - one analyzing the cost of health gains in terms of quality of life by mapping scores from the SDQ to preference-based utility values and another analyzing the cost of health gains in terms of reduced mental illness recovered cases All analyses will be conducted according to Intention-to-treat primary results as well as per protocol sensitivity
Despite the development of psychological treatments in recent decades mental health disorders remain a main cause of disease functional impairments and deaths of adolescents across the world UNICEF estimated that globally over 13 percent of adolescents 10-19 live with a mental disorder Moreover suicide is the fifth most common cause of death for adolescents in the same age-span and the fourth most prevalent cause for adolescents 15-19 years old Reports also show that youth mental illness have increased in recent years Psychological treatments seems not enough to combat this negative development preventive efforts are needed
Family experiences can be a target of prevention given the strong impact on young peoples current and future mental health The quality of the parent-child relationship impacts health quality throughout life Also adverse experiences related to family and parenting dysfunction is one of the main predictors of mental ill-health While adolescence is a period of increased independence parents remain one of the most important people in the young persons life A link between parenting factors during adolescence and anxiety and depression which constitutes 40 of diagnosed adolescent mental disorders is established Parenting factors linked to depression and anxiety include low warmth inter-parental conflict over-involvement and aversiveness
Decades of research support the health benefits of parent training programs that help parents interact and communicate with their children including face-to-face programs delivered in groups and internet-based programs However most studies have concerned children below 13 years of age Given the impact of parenting factors during adolescence on mental health it is important to investigate how parenting programs work for parents of adolescents
Parenting programs on different prevention levels are needed to maximize the benefit on public health However most studies have concerned indicatedselected prevention or treatments Outcomes have mostly concerned symptom reduction To prevent health problems at a population scale more studies are needed of how parenting programs benefit the general population ie universal prevention The general population includes those who do not presently experience clinical problems but where future issues may be prevented through strengthening health-promoting factors eg family relationships
PURPOSE AND RESEARCH QUESTIONS
The aim of this study is to assess the effectiveness of two universal preventive parenting programs for teenagers ABC-teen and ParentWeb A version of the ABC program for children 3-12 years old has been evaluated in a randomized controlled trial but so far no study has investigated ABC-teen Likewise a longer version of the ParentWeb targeting a selected group of parents with elevated levels of conflict with their adolescents has been published but no study on the universal version of ParentWeb The effects of the programs will be evaluated both in comparison to each other and to a Wait-List control Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication
1 What are the programs effect on adolescent and parental mental health
2 What are the programs effect on parenting behaviors and parental self-efficacy
3 What are the programs effect on the relationship between parents and adolescents
4 What are the programs effect on school adjustment
5 What are the programs effect on the adolescents use of tobacco alcohol and drugs
6 To what extent do the parents experience participation in the programs as feasible and satisfying
Research question 1-6 will be reported in the main paper from the project while the following research questions will be reported in following papers
7 Are there predictors and moderators of program effects eg demographic variables and variables related to implementationadherence
8 What are the health economic outcomes of the programs
METHOD
Participants
The sample consisted of 1247 families 1327 parents and 471 adolescents from the general population from 58 sites in 52 municipalities across Sweden The participants were recruited through local advertisements in schools or online municipality channels Parents who were interested were referred to a website with additional information and a consent form All members in a family parents and adolescents were invited to contribute to the data collection in the study questionnaires
Design
The study is a multi-site randomized controlled trial Parents were randomized to ABC-teen ParentWeb or a 6 months Wait-List control After recruitment participants responded to baseline measurements and were subsequently randomized to one of the three study conditions The randomization was conducted centrally by the researchers but with separate randomization list for each site generated at randomizeorg The researchers then informed a local coordinator at the site about participants allocation Parents and adolescents who were included at baseline were invited to answer follow-up questionnaires after 4 and 12 months The wait-list control group parents were invited to participate in either ABC-teen or ParentWeb their choice after 6 months Thus at the 12 month follow-up analyses of program effects will be restricted to comparisons between the programs
Sample size calculation
As the effects of universal interventions are generally small a relatively large study group was required for adequate statistical power also considering that drop-out can be substantial in multi-site studies For a statistical power of 80 200 participating families will be needed to detect small differences in effect size Cohens d 20 with alpha 005 Since the randomization was unbalanced 2-1-1 in ABC-teen ParentWeb and wait list an additional 200 families had to be recruited to reach at least 200 in each condition ie 400 in ABC-teen 200 in ParentWeb and 200 in the wait list This means that a total of 800 families with complete data were needed for the study To account for dropout an additional 447 families were recruited Actual ns in each condition at each measurement point were as follows at the completion of data collection ABC-teen - 669 baseline 520 4 month 458 12 month ParentWeb - 297 baseline 209 4 month 168 12 month Wait list - 281 baseline 210 4 month
Statistical analyses
Linear Mixed Modeling LMM will be used for analyzing the effects of the programs questions 1-5 in two steps First effects at 4 month will be analyzed comparing each of the program to the wait list control Second the two programs will be compared to each other at 4 and 12 month For questions 6 t-tests will be conducted to investigate mean differences between the two program conditions For question 7 LMM-analyses will be conducted with predictors and moderators entered into the equations to test if they have differential effects on the slope of adolescent mental health and parenting variables from baseline to 12 month follow-up For question 8 two different health economic analyses will be conducted - one analyzing the cost of health gains in terms of quality of life by mapping scores from the SDQ to preference-based utility values and another analyzing the cost of health gains in terms of reduced mental illness recovered cases All analyses will be conducted according to Intention-to-treat primary results as well as per protocol sensitivity
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