Clinical trial NCT06366438: A Trial of Two Universal Programs for Parents of Teenagers
Official title: A Randomized Controlled Trial of Two Universal Programs for Parents of Teenagers: ABC (Face-to-face) vs. Parentweb (Online)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Mental Disorder
Adolescent Behavior
Adolescent Development
Parent-Child Relations
Parenting
Keywords: Parenting
Randomized controlled trial
Parent-Child relations
Prevention
Universal
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 1247
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of the three arms upon allocation.
Primary purpose: PREVENTION

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 (e.g., 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 person's 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 indicated/selected 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 (i.e., 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 (e.g., 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 (e.g., demographic variables and variables related to implementation/adherence)?
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 randomize.org). 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 (Cohen's d = .20) with alpha = 0.05. 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 (i.e., 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 n:s 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).

Eligibility criteria: Inclusion Criteria:

* A caregiver or another adult who live part- or full-time with at least one adolescent 13-19 years old.

Exclusion Criteria:

* The family had an ongoing contact (treatment or assessment) concerning a child or adolescent within the psychiatry, social services, primary psychiatric care, habilitation, or equivalent services.
* Health or language deficiencies that make it difficult to respond to questionnaires or participate in group or online parent support.

Primary outcomes:
measure: The Strength and Difficulties Questionnaire (SDQ)
timeFrame: Pre (0 month), 4 months, 12 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre (0 month), 4 months, 12 months
measure: Parental stress scale (PSS)
timeFrame: Pre (0 month), 4 months, 12 months
measure: General Anxiety Disorder Scale (GAD-7)
timeFrame: Pre (0 month), 4 months, 12 months
Secondary outcomes:
measure: Conflict scale
timeFrame: Pre (0 month), 4 months, 12 months
measure: Adult Child Relationship Scale (ACRS)
timeFrame: Pre (0 month), 4 months, 12 months
measure: Adolescents' openness scale
timeFrame: Pre (0 month), 4 months, 12 months
measure: Brief Family Relationship Scale
timeFrame: Pre (0 month), 4 months, 12 months
measure: Positive and Negative Parenting Behaviors
timeFrame: Pre (0 month), 4 months, 12 months
measure: Me as a Parent
timeFrame: Pre (0 month), 4 months, 12 months
measure: Conflict Resolution Efficacy
timeFrame: Pre (0 month), 4 months, 12 months
measure: School Adjustment Scale
timeFrame: Pre (0 month), 4 months, 12 months
measure: Stockholmsenkaten
timeFrame: Pre (0 month), 4 months, 12 months
measure: Satisfaction Questionnaire
timeFrame: At 4- and 12 month follow-ups.
measure: Attendance and engagement measures
timeFrame: At 4- and 12 month follow-ups.
Other outcomes:
measure: Demographics
timeFrame: Pre (0 month)
measure: Organizational and therapist factors
timeFrame: Pre (0 month)
Locations:
city: Bromma
country: Sweden
facility: Bromma stadsdel
city: Danderyd
country: Sweden
facility: Danderyd kommun
city: Edsbyn
country: Sweden
facility: Ovanåkers kommun
city: Farsta
country: Sweden
facility: Farsta stadsdel
city: Gustavsberg
country: Sweden
facility: Värmdö kommun
city: Göteborg
country: Sweden
facility: Göteborgs kommun
city: Götene
country: Sweden
facility: Götene kommun
city: Hallsberg
country: Sweden
facility: Hallsbergs kommun
city: Handen
country: Sweden
facility: Haninge kommun
city: Huddinge
country: Sweden
facility: Huddinge kommun
city: Hägersten
country: Sweden
facility: Hägersten-Älvsjö stadsdel
city: Hägersten
country: Sweden
facility: Tellusborgsskolan
city: Hägersten
country: Sweden
facility: Aspuddens skola
city: Hässelby
country: Sweden
facility: Hässelby Vällingby stadsdel
city: Höör
country: Sweden
facility: Höörs kommun
city: Jakobsberg
country: Sweden
facility: Järfälla kommun
city: Johanneshov
country: Sweden
facility: Skarpnäck stadsdel
city: Johanneshov
country: Sweden
facility: Enskede Årsta Vantör stadsdel
city: Karlsborg
country: Sweden
facility: Karlsborgs kommun
city: Kungsängen
country: Sweden
facility: Upplands-Bro kommun
city: Kungälv
country: Sweden
facility: Kungälvs kommun
city: Leksand
country: Sweden
facility: Leksands kommun
city: Lidingö
country: Sweden
facility: Lidingö kommun
city: Lidköping
country: Sweden
facility: Lidköpings kommun
city: Lilla Edet
country: Sweden
facility: Lilla Edets kommun
city: Lindesberg
country: Sweden
facility: Lindesbergs kommun
city: Linköping
country: Sweden
facility: Linköpings kommun
city: Lomma
country: Sweden
facility: Lomma kommun
city: Lund
country: Sweden
facility: Lunds kommun
city: Mariestad
country: Sweden
facility: Mariestads kommun
city: Märsta
country: Sweden
facility: Sigtuna kommun
city: Nacka
country: Sweden
facility: Nacka kommun
city: Norrköping
country: Sweden
facility: Norrköpings kommun
city: Norrtälje
country: Sweden
facility: Norrtälje kommun
city: Nynäshamn
country: Sweden
facility: Nynäshamns kommun
city: Skellefteå
country: Sweden
facility: Skellefteå kommun
city: Skärholmen
country: Sweden
facility: Skärholmen stadsdel
city: Skövde
country: Sweden
facility: Skövde kommun
city: Sollentuna
country: Sweden
facility: Sollentuna kommun
city: Stenungsund
country: Sweden
facility: Stenungsunds kommun
city: Stockholm
country: Sweden
facility: Kungsholmen stadsdel
city: Stockholm
country: Sweden
facility: Norra Real
city: Stockholm
country: Sweden
facility: Norrmalm stadsdel
city: Stockholm
country: Sweden
facility: Östermalm stadsdel
city: Stockholm
country: Sweden
facility: Södermalm stadsdel
city: Stockholm
country: Sweden
facility: MFJ Hammarby Sjöstad
city: Sundbyberg
country: Sweden
facility: Sundbybergs stad
city: Sundsvall
country: Sweden
facility: Sundsvalls kommun
city: Sävsjö
country: Sweden
facility: Sävsjö kommun
city: Tidaholm
country: Sweden
facility: Tidaholms kommun
city: Trelleborg
country: Sweden
facility: Trelleborgs kommun
city: Tumba
country: Sweden
facility: Botkyrka kommun
city: Täby
country: Sweden
facility: Täby kommun
city: Töreboda
country: Sweden
facility: Töreboda kommun
city: Vallentuna
country: Sweden
facility: Vallentuna kommun
city: Visby
country: Sweden
facility: Gotlands kommun
city: Vällingby
country: Sweden
facility: Vällingbyskolan
city: Växjö
country: Sweden
facility: Växjö kommun
Study officials:
affiliation: Karolinska Institutet
name: Martin Forster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Florean IS, Dobrean A, Pasarelu CR, Georgescu RD, Milea I. The Efficacy of Internet-Based Parenting Programs for Children and Adolescents with Behavior Problems: A Meta-Analysis of Randomized Clinical Trials. Clin Child Fam Psychol Rev. 2020 Dec;23(4):510-528. doi: 10.1007/s10567-020-00326-0. Epub 2020 Sep 8.
citation: Bausback KB, Bunge EL. Meta-analysis of parent training programs utilizing behavior intervention technologies. Soc Sci. 2021;10(10):367. https://doi.org/10.3390/socsci1010 0367 21.
citation: Kaminski JW, Claussen AH. Evidence Base Update for Psychosocial Treatments for Disruptive Behaviors in Children. J Clin Child Adolesc Psychol. 2017 Jul-Aug;46(4):477-499. doi: 10.1080/15374416.2017.1310044. Epub 2017 May 1.
citation: Leijten P, Gardner F, Melendez-Torres GJ, van Aar J, Hutchings J, Schulz S, Knerr W, Overbeek G. Meta-Analyses: Key Parenting Program Components for Disruptive Child Behavior. J Am Acad Child Adolesc Psychiatry. 2019 Feb;58(2):180-190. doi: 10.1016/j.jaac.2018.07.900. Epub 2018 Nov 26.
citation: Ulfsdotter M, Enebrink P, Lindberg L. Effectiveness of a universal health-promoting parenting program: a randomized waitlist-controlled trial of All Children in Focus. BMC Public Health. 2014 Oct 18;14:1083. doi: 10.1186/1471-2458-14-1083.
citation: Wetterborg D, Enebrink P, Lonn Rhodin K, Forster M, Risto E, Dahlstrom J, Forsberg K, Ghaderi A. A pilot randomized controlled trial of Internet-delivered parent training for parents of teenagers. J Fam Psychol. 2019 Oct;33(7):764-774. doi: 10.1037/fam0000541. Epub 2019 Jun 17.
citation: Stewart-Brown SL, Fletcher L, Wadsworth ME. Parent-child relationships and health problems in adulthood in three UK national birth cohort studies. Eur J Public Health. 2005 Dec;15(6):640-6. doi: 10.1093/eurpub/cki049. Epub 2005 Aug 10.
citation: Green JG, McLaughlin KA, Berglund PA, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities and adult psychiatric disorders in the national comorbidity survey replication I: associations with first onset of DSM-IV disorders. Arch Gen Psychiatry. 2010 Feb;67(2):113-23. doi: 10.1001/archgenpsychiatry.2009.186.
citation: Yap MB, Pilkington PD, Ryan SM, Jorm AF. Parental factors associated with depression and anxiety in young people: a systematic review and meta-analysis. J Affect Disord. 2014 Mar;156:8-23. doi: 10.1016/j.jad.2013.11.007. Epub 2013 Nov 18.
citation: Racine N, McArthur BA, Cooke JE, Eirich R, Zhu J, Madigan S. Global Prevalence of Depressive and Anxiety Symptoms in Children and Adolescents During COVID-19: A Meta-analysis. JAMA Pediatr. 2021 Nov 1;175(11):1142-1150. doi: 10.1001/jamapediatrics.2021.2482.
citation: United Nations Children's Fund [UNICEF], The State of the World's Children 2021: On My Mind - Promoting, protecting and caring for children's mental health, UNICEF, New York, October 2021.
citation: Holmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, Roiser JP, Bockting CLH, O'Connor RC, Shafran R, Moulds ML, Craske MG. The Lancet Psychiatry Commission on psychological treatments research in tomorrow's science. Lancet Psychiatry. 2018 Mar;5(3):237-286. doi: 10.1016/S2215-0366(17)30513-8. No abstract available.
citation: Sanders MR, Divan G, Singhal M, Turner KMT, Velleman R, Michelson D, Patel V. Scaling Up Parenting Interventions is Critical for Attaining the Sustainable Development Goals. Child Psychiatry Hum Dev. 2022 Oct;53(5):941-952. doi: 10.1007/s10578-021-01171-0. Epub 2021 May 4.