The PRIMARY study: a study into the effectiveness of daily registration of emotions, social context, activities and weekly feedback for young people who self-harm

Pre-Intervention Monitoring of Affect and Relationships in Youth (PRIMARY): a Randomized Controlled Trial (RCT) into the effectiveness of an Ecological Sampling Method (ESM) intervention in combination with weekly feedback for young people who self-harm

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42088538

Enrollment

106

Registered

2022-10-26

Start date

2021-09-28

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

Self-harm Mental and Behavioural Disorders

Interventions

A Randomized Controlled Trial (RCT) into the effectiveness of the PRIMARY intervention, an Experience Sampling Method (ESM) intervention in combination with weekly feedback for youth who self-harm. Yo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 12 – 25 years (inclusive) 2. =1 act of self-harm in the past year

Exclusion criteria

Exclusion criteria: 1. Insufficient Dutch language skills

Design outcomes

Primary

Measure	Time frame
At baseline, 4 weeks, start of treatment, 10 weeks: 1. Self-harm: five questions concerning the frequency of self-harm, how often medical treatment was necessary after self-harm, age of onset of self-harm, Experience Sampling Method (ESM) question concerning self-harm since the last measurement point 2. Emotion regulation: 18-item version of the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) 3. Social relationships: 11-item version of the Network of Relationships Inventory-Behavior Systems Version (NRI-BSV; Furman & Buhrmester, 1985), Experience Sampling Method (ESM) question concerning current experience of support or conflict	—

Measure

Time frame

At baseline, 4 weeks, start of treatment, 10 weeks: 1. Self-harm: five questions concerning the frequency of self-harm, how often medical treatment was necessary after self-harm, age of onset of self-harm, Experience Sampling Method (ESM) question concerning self-harm since the last measurement point 2. Emotion regulation: 18-item version of the Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) 3. Social relationships: 11-item version of the Network of Relationships Inventory-Behavior Systems Version (NRI-BSV; Furman & Buhrmester, 1985), Experience Sampling Method (ESM) question concerning current experience of support or conflict

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Secondary

Measure	Time frame
At baseline, 4 weeks, start of treatment, 10 weeks: 1. Emotions: Experience Sampling Method (ESM) questions regarding positive (e.g., happy, energetic) and negative (e.g., sad, annoyed) emotions 2. Quality of life: short version of the Recovering Quality of Life (ReQoL; Van Aken, De Beurs, Mulder, Der Feltz-Cornelis, & Maria, 2020) 3. Usability of the online monitor: Usability Metric for User Experience (UMUX; Finstad, 2010) 4. Satisfaction with the PRIMARY intervention: Client Satisfaction Questionnaire-4 (CSQ-4; Attkisson & Greenfield, 1995) 5. Psychopathology: a Dutch extension of the Strengths and Difficulties Questionnaire; Screeningsinstrument Psychische stoornissen (SPSY; Goodman, 1997), and the Depression Anxiety Stress Scales (DASS-21; Antony, Bieling, Cox, Enns, & Swinson, 1998) 6. Personality functioning: SCID-II Screener BPD section (Arntz, Kamphuis, & Derks, 2017), Borderline Symptom List – behavioural items (BSL), Personality Inventory for DSM-5 – Brief form (PID-5-BF; Anderson, Sellbom, & Salekin, 2018), Levels of Personalitiy Functioning Scale 2.0 (LPFS-BF 2.0; Hutsebaut, Feenstra, & Kamphuis, 2016) 7. Life experiences: Life Experiences Survey (LES; Sarason, Johnson, & Sieg, 1978) 8. Impulsivity: Short version of the UPPS Impulsive Behavior Scale (S-UPPS; Whiteside & Lynam, 2001) 9. Loneliness: De Jong Gierveld Schaal (De Jong Gierveld & Van Tilburg, 2006) 10. Impact of corona-restrictions: six items regarding the restrictions in the past week 11. Developmental stage: Developmental Tasks Questionnaire (Laceulle et al., in progress)	—

Measure

Time frame

At baseline, 4 weeks, start of treatment, 10 weeks: 1. Emotions: Experience Sampling Method (ESM) questions regarding positive (e.g., happy, energetic) and negative (e.g., sad, annoyed) emotions 2. Quality of life: short version of the Recovering Quality of Life (ReQoL; Van Aken, De Beurs, Mulder, Der Feltz-Cornelis, & Maria, 2020) 3. Usability of the online monitor: Usability Metric for User Experience (UMUX; Finstad, 2010) 4. Satisfaction with the PRIMARY intervention: Client Satisfaction Questionnaire-4 (CSQ-4; Attkisson & Greenfield, 1995) 5. Psychopathology: a Dutch extension of the Strengths and Difficulties Questionnaire; Screeningsinstrument Psychische stoornissen (SPSY; Goodman, 1997), and the Depression Anxiety Stress Scales (DASS-21; Antony, Bieling, Cox, Enns, & Swinson, 1998) 6. Personality functioning: SCID-II Screener BPD section (Arntz, Kamphuis, & Derks, 2017), Borderline Symptom List – behavioural items (BSL), Personality Inventory for DSM-5 – Brief form (PID-5-BF; Anderson, Sellbom, & Salekin, 2018), Levels of Personalitiy Functioning Scale 2.0 (LPFS-BF 2.0; Hutsebaut, Feenstra, & Kamphuis, 2016) 7. Life experiences: Life Experiences Survey (LES; Sarason, Johnson, & Sieg, 1978) 8. Impulsivity: Short version of the UPPS Impulsive Behavior Scale (S-UPPS; Whiteside & Lynam, 2001) 9. Loneliness: De Jong Gierveld Schaal (De Jong Gierveld & Van Tilburg, 2006) 10. Impact of corona-restrictions: six items regarding the restrictions in the past week 11. Developmental stage: Developmental Tasks Questionnaire (Laceulle et al., in progress)

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026