The objective of the Happy Friends, Positive Minds Cluster Randomized Controlled Trial is to evaluate the effectiveness of Happy Friends, Positive Minds prevention program, delivered by experienced mindfulness health professionals, on self- and…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Participant-level self- and teacher-reported risk for (early onset) depression
and anxiety, self-reported and observed co-rumination, self- and
friend-reported friendship quality, self-reported positive and negative affect,
self-reported interpersonal responses to positive affect and self-reported
anhedonia symptoms will be the primary outcomes.
Secondary outcome
Secondary outcomes will be self-reported anhedonic symptoms, self-reported
mastery, self-reported academic motivation, self-reported concentration,
parent-reported health care use and teacher-reported emotional and behavioral
problems and academic competence.
Background summary
A growing literature indicates that adolescent girls who talk with friends
about interpersonal problems or worries in a way that is excessive,
speculative, and negatively focused, with an intense focus on distress and
uncertainty about whether problems will be manageable or solved (i.e.,
co-rumination) are at heightened risk for early onset internalizing symptoms
and disorders. However, to date, there are no prevention programs available
that target co-rumination in adolescent girls. Given the emphasis on the
cultivation of present moment awareness, practicing appreciation and gratitude
and meta-awareness of the dynamics between thoughts, emotions, body sensations
and impulses, mindfulness-training may be particularly beneficial for girls who
engage excessively together in repetitive, negative, and judgmental
interactions. As such, we developed an app-based mindfulness training program
that will be available via schools after the Cluster Randomized Controlled
Trial phase, and that focuses on teaching mindfulness skills on the dyadic
level and that supports excessive co-ruminating girls to integrate these skills
in their everyday lives: the Happy Friends, Positive Minds (HFPM) secondary
school-edition prevention program. We will include 160 friendship dyads who are
primarily characterized by high levels of co-rumination within their daily
interaction patterns. The goal of this program is to train dyads to shift
dyadic maladaptive emotion regulation patterns to more adaptive emotion
regulation strategies within their dyadic interactions, while continuing to
reap the benefits of their close, intimate friendships and exploring healthy,
new alternatives for excessive co-rumination.
Study objective
The objective of the Happy Friends, Positive Minds Cluster Randomized
Controlled Trial is to evaluate the effectiveness of Happy Friends, Positive
Minds prevention program, delivered by experienced mindfulness health
professionals, on self- and teacher-reported mental health outcomes in a sample
of 320 Dutch girls from age 13 to 15 years old, and to unveil the mechanisms of
change of the program.
Study design
The HFPM Cluster Randomised Controlled Trial has two arms: (1) an intervention
condition in which 80 girls* friendship dyads (n = 160 high-risk girls) will
receive the training program HFPM between November 2023 and July 2024, and (2)
a control condition in which 80 girls* friendship dyads (n = 160 high-risk
girls) will receive teaching-and-care-as-usual (TAU). To prevent contamination
across the two trial arms, friendship dyads will be the unit of randomisation.
The 14-week prevention program will be delivered in four phases between
November 2023 and June 2024 (phase 1: November 2023; phase 2: January 2024;
phase 3: March 2024, and phase 4: May/June 2024). The T0 baseline measure will
take place in September and October 2023, followed by a T1 measure (December
2023), a T2 measure (February 2024), a T3 measure (April 2024), a T4 measure
(July 2024) and a one-year follow-up measure in July 2025 (T5 measure).
Intervention
The Happy Friends, Positive Minds prevention program is designed to train
social-emotional-behavioral self-regulation within the supportive close
friendship context by facilitating dyadic as well as individual experiential
learning. This program was developed between 2020 and 2022 using the
Intervention Mapping Approach for planning health promotion programs
(Bartholomew et al., 2016) and the Template for Intervention Description and
Replication (TIDieR) checklist and guide for reporting complex interventions
(Hoffmann et al., 2014). The program comprises 14 guided, weekly online lessons
with mindfulness practices and psychoeducation, guiding the dyadic use of the
eMental health application App je Happy. The goal of this program is to train
160 Dutch (80 dyads) high risk girls between ages 13 to 15 to shift dyadic
maladaptive emotion regulation patterns to more adaptive emotion regulation
strategies within their dyadic interactions, while continuing to reap the
benefits of their close, intimate friendships and exploring healthy, new
alternatives for excessive co-rumination.
Study burden and risks
The burden and risks for girls associated with participation in the study are
seen as minimal given that the study does in no way interfere with regular
education of the girls and is focused on natural occurring interactions and
activities within girls* close friendships. The current study offers girls the
opportunity to join a study focused on gaining more knowledge about the
prevention excessive co-rumination processes and internalizing problems 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/meisje must meet the following five
inclusion criteria:
(1) Aged 13 to age 15 years.
(2) Visiting a secondary school of Samenwerkingsverband Koers VO.
(3) Attending second or third grade of mainstream secondary education in
academic year 2023/2024.
(4) *Assigned female at birth, being a female transgender or being a nonbinary
adolescent.
(5) Having a mutual same gender (*assigned female at birth, being a female
transgender or being
a nonbinary adolescent) good or best friend at the same school.
To be eligible for inclusion, a dyad must meet the following inclusion
criterium:
(1) At least one of the two girls of one friendship dyad, or both girls, should
have a score of at least one standard deviation above the mean co-rumination
screening score on the Co-rumination Questionnaire Short (Hankin et al., 2010).
Exclusion criteria
Exclusion criteria at the school level (to mitigate any risk of difficulties in
trial implementation):
(1) Not having a headteacher in academic year 2023/2024.
(2) Judged as 'inadequate* during most recent school inspection by the Dutch
Inspectorate of Education.
(3) Implementing another mindfulness-based intervention in academic year
2023/2024.
Exclusion criterium at the individual girl level:
(1) Following an/participating in an individual or group-based
mindfulness-based training in academic year 2023/2024.
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 | NL82696.078.23 |