Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
3. september 2026 oppdatert av: Liat Itzhaky, Columbia University
The goal of this study is to finalize a version of the Safety Planning Intervention suitable for 6-12-year-old children. This intervention provides individuals with strategies to reduce the risk of suicidal behavior.
The main questions it aims to answer are:
- Does the intervention appear clear and acceptable to the children and caregivers?
- Does the intervention work to reduce suicidal behavior? Researchers will compare the group that received the intervention to a group that did not receive it, and to a group that received it and reported daily on its use.
Participants will:
- Children and parents will respond to questions in an interview and through self-reports in an in-person meeting
- Children and parents will receive the intervention (those in the intervention groups)
- Parents will report daily for one month (only those in the intervention + reporting group)
- Children and parents will meet with the study team through a video call at 1 and 3 months from the first meeting for an interview.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Children Hospital of Philadelphia
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Children aged 6-12
- Active suicidal ideation or a suicidal behavior in the last month
- The child and their caregiver are English speakers
- The child will be in an outpatient treatment at CHOP at the time of enrollment and baseline procedures
Exclusion Criteria:
- Child received a diagnosis of a psychotic disorder or intellectual disability
- Child is suffering from active mania
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Behandling som vanlig (TAU)
|
|
|
Eksperimentell: Child-safety planning intervention (C-SPI) + TAU
Child - Safety Planning Intervention
|
The Child Safety Planning Intervention (C-SPI) provides psychoeducation to children and caregivers about emotions, thoughts, and behaviors, emphasizing how these interact and change over time.
Suicidal thoughts are framed as temporary reactions to triggers that can be recognized and managed.
The intervention reviews a recent suicidal crisis to identify triggers, thoughts, feelings, and behaviors, which are then used to help the child recognize warning signs in the future.
These signs are organized into levels (green, yellow, red), each linked to specific action steps.
Andre navn:
|
|
Annen: C-SPI + TAU + ecological momentary assessment
Child - Safety Planning Intervention and daily reporting
|
The Child Safety Planning Intervention (C-SPI) provides psychoeducation to children and caregivers about emotions, thoughts, and behaviors, emphasizing how these interact and change over time.
Suicidal thoughts are framed as temporary reactions to triggers that can be recognized and managed.
The intervention reviews a recent suicidal crisis to identify triggers, thoughts, feelings, and behaviors, which are then used to help the child recognize warning signs in the future.
These signs are organized into levels (green, yellow, red), each linked to specific action steps.
Andre navn:
C-SPI and daily, self-reported use of C-SPI
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility and acceptability of the C-SPI
Tidsramme: At baseline (following the intervention), and at 1 and 3 months follow-ups
|
Whether intervention is clear and perceived as helpful on a scale of 1-5 (higher score indicates better perception of helpfulness)
|
At baseline (following the intervention), and at 1 and 3 months follow-ups
|
|
Utilization of the C-SPI
Tidsramme: Daily for a month (through EMA), and at 1 and 3 month follow-ups
|
Whether the C-SPI was used or not (0 or 1)
|
Daily for a month (through EMA), and at 1 and 3 month follow-ups
|
|
Suicidal behavior
Tidsramme: 1 and 3 months
|
Whether suicidal behavior was present and how many times (count variable beginning with zero; higher score indicating worse outcome)
|
1 and 3 months
|
|
Suicidal ideation severity
Tidsramme: 1 and 3 months
|
On a scale of 0-5 with higher score indicating worse outcome
|
1 and 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mental health treatment engagement/service utilization
Tidsramme: 1 and 3 months
|
Number of contact with mental health providers (count variable beginning with zero; higher score indicating better outcome)
|
1 and 3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
9. september 2026
Primær fullføring (Antatt)
31. mai 2027
Studiet fullført (Antatt)
31. mai 2027
Datoer for studieregistrering
Først innsendt
27. april 2026
Først innsendt som oppfylte QC-kriteriene
27. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AAAV3403
Plan for individuelle deltakerdata (IPD)
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