A Trial of Two Universal Programs for Parents of Teenagers

NCT ID: NCT06366438

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-11
• Study Completion Date: 2024-03-24

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).

Conditions

Mental Health Issue; Mental Disorder; Adolescent Behavior; Adolescent Development; Parent-Child Relations; Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ABC-teen

The ABC-teen is a universal parenting program where two trained leaders meet parents meet in groups (10-15 parents) at four occasions (2.5 hours each). One or two follow-up meetings are also offered. The themes that are covered during the meetings include: spending time together, communication, parental stress management and emotion regulation, and problem solving/conflict resolution.

Group Type: EXPERIMENTAL

ABC-teen

Intervention Type: BEHAVIORAL

See above

ParentWeb

ParentWeb is an online-based program where parents individually work with material online (text, images, clips, quizzes), while they receive support from a parent guide through asynchronous text messages. The program includes four main modules that are expected to be covered in eight weeks. The themes of the modules include: spending time together, communication, problem solving/conflict resolution, and keeping in touch while letting go of control.

Group Type: EXPERIMENTAL

ParentWeb

Intervention Type: BEHAVIORAL

See above

Wait-List

The parents will be on a six months wait-list control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ABC-teen

See above

Intervention Type: BEHAVIORAL

ParentWeb

See above

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Martin Forster

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Forster, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Götene kommun

Götene, , Sweden

Värmdö kommun

Gustavsberg, , Sweden

Hallsbergs kommun

Hallsberg, , Sweden

Haninge kommun

Handen, , Sweden

Hägersten-Älvsjö stadsdel

Hägersten, , Sweden

Tellusborgsskolan

Hägersten, , Sweden

Aspuddens skola

Hägersten, , Sweden

Hässelby Vällingby stadsdel

Hässelby, , Sweden

Höörs kommun

Höör, , Sweden

Huddinge kommun

Huddinge, , Sweden

Bromma stadsdel

Bromma, , Sweden

Danderyd kommun

Danderyd, , Sweden

Ovanåkers kommun

Edsbyn, , Sweden

Farsta stadsdel

Farsta, , Sweden

Göteborgs kommun

Gothenburg, , Sweden

Järfälla kommun

Jakobsberg, , Sweden

Skarpnäck stadsdel

Johanneshov, , Sweden

Enskede Årsta Vantör stadsdel

Johanneshov, , Sweden

Karlsborgs kommun

Karlsborg, , Sweden

Kungälvs kommun

Kungälv, , Sweden

Upplands-Bro kommun

Kungsängen, , Sweden

Leksands kommun

Leksand, , Sweden

Lidingö kommun

Lidingö, , Sweden

Lidköpings kommun

Lidköping, , Sweden

Lilla Edets kommun

Lilla Edet, , Sweden

Lindesbergs kommun

Lindesberg, , Sweden

Linköpings kommun

Linköping, , Sweden

Lomma kommun

Lomma, , Sweden

Lunds kommun

Lund, , Sweden

Mariestads kommun

Mariestad, , Sweden

Sigtuna kommun

Märsta, , Sweden

Nacka kommun

Nacka, , Sweden

Norrköpings kommun

Norrköping, , Sweden

Norrtälje kommun

Norrtälje, , Sweden

Nynäshamns kommun

Nynäshamn, , Sweden

Sävsjö kommun

Sävsjö, , Sweden

Skärholmen stadsdel

Skärholmen, , Sweden

Skellefteå kommun

Skellefteå, , Sweden

Skövde kommun

Skövde, , Sweden

Sollentuna kommun

Sollentuna, , Sweden

Stenungsunds kommun

Stenungsund, , Sweden

Kungsholmen stadsdel

Stockholm, , Sweden

Norra Real

Stockholm, , Sweden

Norrmalm stadsdel

Stockholm, , Sweden

Östermalm stadsdel

Stockholm, , Sweden

Södermalm stadsdel

Stockholm, , Sweden

MFJ Hammarby Sjöstad

Stockholm, , Sweden

Sundbybergs stad

Sundbyberg, , Sweden

Sundsvalls kommun

Sundsvall, , Sweden

Täby kommun

Täby, , Sweden

Tidaholms kommun

Tidaholm, , Sweden

Töreboda kommun

Töreboda, , Sweden

Trelleborgs kommun

Trelleborg, , Sweden

Botkyrka kommun

Tumba, , Sweden

Vallentuna kommun

Vallentuna, , Sweden

Växjö kommun

Vaxjo, , Sweden

Vällingbyskolan

Vällingby, , Sweden

Gotlands kommun

Visby, , Sweden

Countries

Sweden

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Other Identifiers

ABC vs Parentweb

Identifier Type: -

Identifier Source: org_study_id