The primary aim of the cluster Randomized Controlled Trial (cRCT) is to evaluate the effectiveness of the Girls United prevention program on self- and parent-reported mental health outcomes in a sample of max 320 young adolescent girls aged 10 to 12…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
corumineren, internaliserende symptomen en stoornissen (depressie/angst)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Self-reported co-rumination
Secondary outcome
Secondary outcome measures are self-reported anxiety symptoms, self-reported
depression symptoms, self-reported friendship quality, self-reported positive
and negative affect, interpersonal responses to positive affect, self-reported
anxiety symptoms, self-reported self-worth.
Background summary
Research shows that young adolescent girls who engage in excessive,
speculative, and negatively focused discussions with friends about
interpersonal problems and worries * a behaviour also known as co-rumination*
face a greater risk of developing internalizing symptoms (i.e., depression and
anxiety) and reduced friendship quality. Currently there are no school-based
prevention programs available that specifically address high levels of
co-rumination in young adolescent girls aged 10-12-years old. Mindfulness
training, with a focus on present-moment awareness, appreciation, gratitude,
and awareness of the dynamics between thoughts, emotions, bodily sensations,
and impulses, can be helpful for girls who engage in repetitive and judgmental
negative interactions. To address this need, we developed a blended,
mindfulness and psycho-education prevention program called Girls United and the
current cluster Randomized Controlled Trial will test program*s effectiveness
in primarily reducing co-rumination and secondarily internalizing problems.
Girls United aims to teach mindfulness skills at a dyadic level, i.e., between
two close female friends and thereby helps young girls prone to co-rumination
incorporate these techniques into their daily lives. This evidence-based
prevention program will then be implemented across Dutch mainstream primary
schools.
Study objective
The primary aim of the cluster Randomized Controlled Trial (cRCT) is to
evaluate the effectiveness of the Girls United prevention program on self- and
parent-reported mental health outcomes in a sample of max 320 young adolescent
girls aged 10 to 12 (attending mainstream primary schools in the Netherlands)
displaying high levels of self-reported co-rumination. Additionally, the study
aims to identify the mechanisms of change of the program.
Study design
The Girls United cluster Randomised Controlled Trial has two arms: (1) an
intervention condition in which max 80 girls* friendship dyads (n = max 160
with high levels of self-reported co-rumination) will receive the Girls United
program for 14 weeks, and (2) a control condition in which max 80 girls*
friendship dyads (n = max 160 with high levels of self-reported co-rumination)
will receive teaching-and-care-as-usual (TAU). The intervention will be offered
in two consecutive cohorts during academic year 2025/2026 and 2026/2027.
Randomisation will take place at the classroom level.
Intervention
The Girls United prevention program aims to foster social-emotional-behavioral
self-regulation within a supportive close-friendship context through
incorporation of both dyadic and individual experiential learning. Developed
between 2020 and 2023 using the Intervention Mapping Approach for health
promotion planning, the program includes 14 weekly online lessons delivered by
trained facilitators. These lessons integrate psychoeducation and mindfulness
practices, guiding participants in using the application App yourself Happy app
within their friendship dyads. The program's aim is to support 160 Dutch girls
(80 dyads) aged 10 to 12 who are at high risk, helping them shift from
maladaptive to adaptive emotion regulation patterns in their daily
interactions. This approach encourages the benefits of close, intimate
friendships while introducing healthy alternatives to excessive co-rumination.
Study burden and risks
The study is expected to pose minimal burden and risks for participating girls,
as it does not interfere or disrupt their regular education practices and
focuses on naturally occurring interactions and activities within their close
friendships. Additionally, the study provides an opportunity for participants
to contribute to research aimed at enhancing understanding and preventing
excessive co-rumination and internalizing issues in adolescent girls.
Rochussenstraat 198
Rotterdam 3015 EK
NL
Rochussenstraat 198
Rotterdam 3015 EK
NL
Listed location countries
Age
Inclusion criteria
To be eligible for inclusion, a participant/girl must meet all of the following
criteria:
1) Aged 10 to 12 years.
2) Visiting a primary school of RiBA, BLICK op onderwijs, and Scholennetwerk
BSI (i.e., collaborative school network).
3) Attending 5th or 6th grade of mainstream upper primary education in academic
year 2025/2026 or 2026/2027.
4) Being a cisgender woman or being a transgender woman.
5) Having a good or best friend (being a cisgender woman or being a transgender
woman) at the same school.
To be eligible for inclusion, a dyad/girls must meet the following inclusion
criteria:
By lack of an official cut-off score for high co-rumination levels, we will
base our inclusion on a distribution-based technique. That is, we will include
friendship dyads of which at least one of the two girls, or both girls, have a
score above the median co-rumination screening score on the Co-rumination
Questionnaire-Short (Hankin, Stone & Wright, 2010). This will result in a
sample of the 50% highest scoring girls on co-rumination. Note that a
distribution-based technique is a common-used technique to select a high-risk
population of clinical significance in the absence of meaningful clinical
cut-offs (Loan, Symonds, Vargas-Chanes & Fridley, 2003).
Exclusion criteria
Exclusion criteria at participant/girl level:
1) Participating in an another individual or group-based mindfulness-based
training in academic year 2025/2026 or 2026/2027.
Exclusion criteria at the school level (to mitigate any risk of difficulties in
trial implementation):
1) Not having a headteacher in academic year 2025/2026 or 2026/2027.
2) Judged as *inadequate* during the most recent school inspection by the Dutch
Inspectorate of Education.
3) Implementing another mindfulness-based intervention in academic year
2025/2026 or 2026/2027.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88776.100.25 |