NCT06366438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

58 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2.1 years

First QC Date

April 9, 2024

Last Update Submit

April 19, 2024

Conditions

Keywords

ParentingRandomized controlled trialParent-Child relationsPreventionUniversal

Outcome Measures

Primary Outcomes (4)

  • The Strength and Difficulties Questionnaire (SDQ)

    Measures adolescent mental health. Rated by parents and adolescents. The scale consists of five sub-scales and a supplement. In this study, the Total problem scale will be used as primary outcome measure. The Total problem scale consists of the sum of the following four sub-scales: Hyperactivity, Emotional problems, Conduct problems, and Peer problems. The range of the Total problem scale is 0 to 60 points, where higher scores indicate more problems.

    Pre (0 month), 4 months, 12 months

  • Patient Health Questionnaire (PHQ-9)

    Measures parental mental health (specifically depression). Rated by parents. The range of the scale is 0 to 27 points, where higher scores indicates more depressive symptoms.

    Pre (0 month), 4 months, 12 months

  • Parental stress scale (PSS)

    Measures parental mental health (specifically parental stress). Rated by parents. The range of the scale is 0 to 32 points, where higher scores indicate more stress.

    Pre (0 month), 4 months, 12 months

  • General Anxiety Disorder Scale (GAD-7)

    Measures parental mental health (specifically anxiety). Rated by parents. The range of the scale is 0 to 21, where higher scores indicate more symptoms of anxiety.

    Pre (0 month), 4 months, 12 months

Secondary Outcomes (11)

  • Conflict scale

    Pre (0 month), 4 months, 12 months

  • Adult Child Relationship Scale (ACRS)

    Pre (0 month), 4 months, 12 months

  • Adolescents' openness scale

    Pre (0 month), 4 months, 12 months

  • Brief Family Relationship Scale

    Pre (0 month), 4 months, 12 months

  • Positive and Negative Parenting Behaviors

    Pre (0 month), 4 months, 12 months

  • +6 more secondary outcomes

Other Outcomes (2)

  • Demographics

    Pre (0 month)

  • Organizational and therapist factors

    Pre (0 month)

Study Arms (3)

ABC-teen

EXPERIMENTAL

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.

Behavioral: ABC-teen

ParentWeb

EXPERIMENTAL

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.

Behavioral: ParentWeb

Wait-List

NO INTERVENTION

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

Interventions

ABC-teenBEHAVIORAL

See above

ABC-teen
ParentWebBEHAVIORAL

See above

ParentWeb

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (58)

Bromma stadsdel

Bromma, 16867, Sweden

Location

Danderyd kommun

Danderyd, 18231, Sweden

Location

Ovanåkers kommun

Edsbyn, 82831, Sweden

Location

Farsta stadsdel

Farsta, 12347, Sweden

Location

Göteborgs kommun

Gothenburg, 41140, Sweden

Location

Götene kommun

Götene, 53380, Sweden

Location

Värmdö kommun

Gustavsberg, 13430, Sweden

Location

Hallsbergs kommun

Hallsberg, 69480, Sweden

Location

Haninge kommun

Handen, 13640, Sweden

Location

Hägersten-Älvsjö stadsdel

Hägersten, 12626, Sweden

Location

Tellusborgsskolan

Hägersten, 12649, Sweden

Location

Aspuddens skola

Hägersten, 12655, Sweden

Location

Hässelby Vällingby stadsdel

Hässelby, 16555, Sweden

Location

Höörs kommun

Höör, 24331, Sweden

Location

Huddinge kommun

Huddinge, 14161, Sweden

Location

Järfälla kommun

Jakobsberg, 17757, Sweden

Location

Skarpnäck stadsdel

Johanneshov, 12153, Sweden

Location

Enskede Årsta Vantör stadsdel

Johanneshov, 12162, Sweden

Location

Karlsborgs kommun

Karlsborg, 54630, Sweden

Location

Kungälvs kommun

Kungälv, 44281, Sweden

Location

Upplands-Bro kommun

Kungsängen, 19640, Sweden

Location

Leksands kommun

Leksand, 79331, Sweden

Location

Lidingö kommun

Lidingö, 18182, Sweden

Location

Lidköpings kommun

Lidköping, 53132, Sweden

Location

Lilla Edets kommun

Lilla Edet, 46330, Sweden

Location

Lindesbergs kommun

Lindesberg, 71135, Sweden

Location

Linköpings kommun

Linköping, 58232, Sweden

Location

Lomma kommun

Lomma, 23431, Sweden

Location

Lunds kommun

Lund, 22223, Sweden

Location

Mariestads kommun

Mariestad, 54230, Sweden

Location

Sigtuna kommun

Märsta, 19547, Sweden

Location

Nacka kommun

Nacka, 13157, Sweden

Location

Norrköpings kommun

Norrköping, 60224, Sweden

Location

Norrtälje kommun

Norrtälje, 76128, Sweden

Location

Nynäshamns kommun

Nynäshamn, 14931, Sweden

Location

Sävsjö kommun

Sävsjö, 57631, Sweden

Location

Skärholmen stadsdel

Skärholmen, 12748, Sweden

Location

Skellefteå kommun

Skellefteå, 93131, Sweden

Location

Skövde kommun

Skövde, 54183, Sweden

Location

Sollentuna kommun

Sollentuna, 19147, Sweden

Location

Stenungsunds kommun

Stenungsund, 44431, Sweden

Location

Kungsholmen stadsdel

Stockholm, 11218, Sweden

Location

Norra Real

Stockholm, 11355, Sweden

Location

Norrmalm stadsdel

Stockholm, 11526, Sweden

Location

Östermalm stadsdel

Stockholm, 11526, Sweden

Location

Södermalm stadsdel

Stockholm, 12030, Sweden

Location

MFJ Hammarby Sjöstad

Stockholm, 12068, Sweden

Location

Sundbybergs stad

Sundbyberg, 17458, Sweden

Location

Sundsvalls kommun

Sundsvall, 85232, Sweden

Location

Täby kommun

Täby, 18339, Sweden

Location

Tidaholms kommun

Tidaholm, 52231, Sweden

Location

Töreboda kommun

Töreboda, 54530, Sweden

Location

Trelleborgs kommun

Trelleborg, 23142, Sweden

Location

Botkyrka kommun

Tumba, 147 41, Sweden

Location

Vallentuna kommun

Vallentuna, 18686, Sweden

Location

Växjö kommun

Vaxjo, 35230, Sweden

Location

Vällingbyskolan

Vällingby, 16264, Sweden

Location

Gotlands kommun

Visby, 12142, Sweden

Location

Related Publications (13)

  • 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.

    PMID: 32897527BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 28459280BACKGROUND
  • 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.

    PMID: 30738545BACKGROUND
  • 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.

    PMID: 25326710BACKGROUND
  • 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.

    PMID: 31204818BACKGROUND
  • 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.

    PMID: 16093299BACKGROUND
  • 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.

    PMID: 20124111BACKGROUND
  • 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.

    PMID: 24308895BACKGROUND
  • 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.

    PMID: 34369987BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 29482764BACKGROUND
  • 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.

    PMID: 33948778BACKGROUND

MeSH Terms

Conditions

Mental DisordersAdolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Martin Forster, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of the three arms upon allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 15, 2024

Study Start

December 11, 2021

Primary Completion

January 15, 2024

Study Completion

March 24, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations