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The Happy Friends, Positive Minds cluster randomized controlled trial

Dyadic-based targeted prevention of maladaptive co-rumination and internalizing problems and disorders in Dutch early adolescent girls: a cluster randomized controlled trial on the effectiveness of the blended school-based mindfulness prevention program Happy Friends, Positive Minds.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54246670
Enrollment
1000
Registered
2023-02-24
Start date
2023-08-16
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of excessive co-rumination and related internalizing symptoms and disorders. Mental and Behavioural Disorders

Interventions

Current interventions as of 07/12/2023: The HFPM cRCT has two arms: (1) an intervention condition in which 80 girls’ friendship dyads (n = 160 high-risk girls) will receive the training program HFPM b
n = 160 girls) or to the control group (CAU
80 dyads
n = 160 girls) by an independent researcher, using CASTOR Electronic Data Capture (EDC), a web-based electronic case record form and randomisation program that is compatible with the GCP guidelines. I

Sponsors

Rotterdam University of Applied Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: To be eligible for inclusion, a participant/girl 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/girls must meet the following inclusion criterion: 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: 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 criteria at the individual girl level: 1. Following an/participating in an individual or group-based mindfulness-based training in academic year 2023/2024.

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 07/12/2023: The 14-week HFPM program will be delivered in two cohorts (cohort 1: academic year 2023-2024; cohort 2: academic year 2024-2025) in four phases between February 2024 and May 2025 for both cohorts. The T0 baseline measurements for both cohorts will take place from October 2023 (cohort 1) and from October 2024 (cohort 2), followed by T1 measurements (from February 2024 for cohort 1 and from December 2024 for cohort 2), T2 measurements (from April 2024 for cohort 1 and from February 2025 for cohort 2), T3 measurements (from June 2024 for cohort 1 and from April 2025 for Cohort 2), T4 post-intervention measurements (from September 2024 for cohort 1 and from Juli 2025 for cohort 2) and a one-year long-term follow-up measurement (T5) from July 2025 and 2026. All data will be collected via Qualtrics at T0, T1, T2, T3, T4 and 1-year follow-up measures T5 (girls) 1. Self-reported negative affect: co-rumination (girls; questionnaire; Co-Rumination Questionnaire-Short, Hankin et al., 2010) 2. Observed regulation of negative affect: co-rumination (Problem Talk Task; Rose et al., 2014; Dutch version; Vuijk et al., 2022) 3. Self-reported (early onset risk for) depressive symptoms/disorder (girls; questionnaire; Child Depression Inventory; CDI-2; Bodden, Braet, & Stikkelbroek, 2016) Previous primary outcome measure: 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): 1. Self-reported negative affect: co-rumination (girls; questionnaire; Co-Rumination Questionnaire-Short, Hankin et al., 2010); 2. Self-reported (early onset risk for) depressive symptoms/disorder (girls; questionnaire; Child Depression Inventory; CDI-2; Bodden, Braet, & Stikkelbroek, 2016); 3. Self-reported (early onset risk for) generalized anxiety symptoms/disorder

Secondary

MeasureTime frame
Current secondary outcome measures as of 07/12/2023: Collected at T0, T1, T2, T3, T4 and 1-year follow-up measures T5 (girls): 1. Self-reported (early onset risk for) generalized anxiety symptoms/disorder (girls/ questionnaire; subscale Generalized Anxiety Disorder (GAD) of the Revised Children’s Anxiety and Depression Scale; RCADS, Chorpita et al., 2000) 2. Self-reported problem anxiety talk (girls/ questionnaire; Problem Anxiety Talk Scale; PATS, Herzig, Steward, & Treadwell, 2022) 3. Self-reported positive and negative affect (girls/ questionnaire; Dutch version of the Positive and Negative Affect Schedule for Children; PANAS-C, Laurent et al., 1999; De Bolle, De Fruyt, & Decuyper, 2010) 4. Self-reported interpersonal responses to positive affect (girls/ questionnaire; Co-Dampening and Co-Enhancing Questionnaire; CoDEQ, Bastin et al., 2019) 5. Self-reported quality of the friendship with the dyad-friend and investments in the interpersonal relation (girls/ questionnaire; Network of Relationships Inventory; NRI, Furman & Buhrmester, 1992) 6. Regulation of negative affect: co-rumination (girls/ observations; Dutch version of the standardized Problem Talk task (Rose et al., 2014; Vuijk, Bul, & Amesz, 2021) 7. Self-reported anhedonic symptoms (girls/ questionnaire; Leuven Anhedonia Self-report Scale, LASS, Nelis et al., 2015) 8. Self-reported mastery (girls/ questionnaire; Dutch version of the Pearling Mastery Scale, PMS, Pearling & Schooler, 1998) 7. Parental health care use of their child/family (parents/ questionnaire; Parental health care use of their child/family will be measured by three questions about whether the child and/or family received health care for psychosocial, emotional or behavioral problems of the child in the last 12 months and about the underlying cause(s) and about the duration of the care. Previous secondary outcome measures: The T0 baseline measure will take place in September and October 2023, followed by a T1 measure (December 2023), a T

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026