- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07303062
Foreldreprogram for Mental Helse hos Ungdom for Forbedring av Forholdet mellom Barn og Voksne (AMP-CARE)
Evaluering av innvirkningen av foreldreprogram for ungdommers psykisk helse for forbedring av barn-voksen-forhold (AMP-CARE)
The purpose of this research study is to learn if a parenting program called Adolescent Mental Health Parenting Program for Child Adult Relationship Enhancement (AMP-CARE) can help parents have more confidence in parenting their teen and improve their knowledge about normal teen development and teen mental health. The main questions it aims to answer are:
- Does the AMP-CARE parenting program improve confidence in teen parenting and positive parenting?
- Does the AMP-CARE parenting program improve parent knowledge about mental health?
Researchers will compare participants who complete the parenting program to those who do not.
Participants will:
- Complete 2 surveys, one at the start of the study and one 6 -12 weeks later
- Half of the participants will be randomly picked to attend the 6 virtual AMP-CARE sessions right away.
- The other half will have the opportunity to attend AMP-CARE after they complete the second survey.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
In this randomized controlled trial, 60 parents of teens, ages 11-14 years, will be randomized to either AMP-CARE or wait-list control to achieve the following aims:
AIM 1. To measure the impact of AMP-CARE on parent mental health literacy as measured by the Parental Child Mental Health Literacy Questionnaire (PCMHLQ).
AIM 2: To measure the impact of AMP-CARE on parenting self-efficacy as measured by the Parenting Self Efficacy Scale.
AIM 3: To measure the impact of AMP-CARE on promotive parenting practices assessed by the Positive Parenting and Parental Involvement subscales of the Alabama Parenting Questionnaire.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Cary, North Carolina, Forente stater, 27519
- Rekruttering
- UNC Pediatrics at Panther Creek
-
Ta kontakt med:
- Priyanka Rao, MD
- Telefonnummer: (919) 481-4997
- E-post: priyanka_rao@med.unc.edu
-
Chapel Hill, North Carolina, Forente stater, 27517
- Rekruttering
- UNC Children's Primary and Specialty Care at Carolina Pointe II
-
Hovedetterforsker:
- Yasamin Sanii, MD
-
Underetterforsker:
- Samantha Schilling, MD, MSPH
-
Ta kontakt med:
- Katherine Jordan, MD
- Telefonnummer: (984) 974-6669
- E-post: katherine_jordan@med.unc.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Parent or guardian of teen age 11-14 years
- Receiving primary care at selected study sites
- English speaking
Exclusion Criteria:
- Parents of children with severe mental illness (indicated by psychiatric hospitalization in the last 12 months or previous diagnosis of psychosis)
- Parents of children with severe developmental delay (indicated by prior diagnosis of severe neurodevelopmental impairment, global developmental delay, severe expressive language delay)
- Not available at time group is scheduled
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: AMP-CARE
Parents will attend the 6 virtual sessions with a group of about 5-10 parents and 2 facilitators. The AMP-CARE group sessions are held for about 90 minutes once per week. Sessions include didactics, role playing, vignettes, and weekly home practice to build positive parenting techniques. |
The goals of AMP-CARE are to teach parents how to form a positive relationship with their teen and to teach about typical adolescent development and mental health. Each AMP-CARE session will be led by 1 or 2 trainers. About 4 to 13 parents will attend each virtual session lasting approximately 1.5 hours. Sessions will be weekly for 6 weeks. Participants are encouraged to practice the skills learned at AMP-CARE between the sessions. |
|
Ingen inngripen: Waitlist Control
Parents in the control group will be offered the intervention after completing the second study questionnaire. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent Mental Health Literacy
Tidsramme: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Parent Mental Health Literacy was assessed with 23-item self-report measure, the Parental Child Mental Health Literacy Questionnaire. Using a 5-pt scale with endpoints of "0=strongly disagree" and "4=strongly agree," parents were asked to indicate their level of agreement with statements related to 5 constructs: mental health recognition, beliefs, knowledge, help-seeking confidence, and fear of stigma. Scores ranged from 0 to 4. Higher scores indicate greater literacy. |
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent Self Efficacy
Tidsramme: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Parenting self-efficacy was assessed with the 19-item self-report measure Parenting Self Efficacy Scale. Using a 5-point scale, parents indicated how frequently states related to their efficacy to develop positive teenager behavior, their efficacy to respond competently to negative teenager behavior, and their monitoring efficacy were true from "1=never" to 5 "always." Total scores ranged from 1 to 5 with higher scores indicating greater self-efficacy. |
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
|
Promotive Parenting Practices
Tidsramme: From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Promotive parenting practices were assessed with 16 self-report items from two subscales of Alabama Parenting Questionnaire. The positive involvement subscale includes 10 items, with a range of possible scores from 10 to 50. The positive parenting subscale includes 6 items, with a range of possible scores from 6 to 30. Parents rate the frequency with which each parenting practice occurs in their home from "1=never" to "5=always." Higher scores indicate more positive parenting. |
From enrollment to completion of AMP-CARE program or 6-12 weeks after enrollment.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Samantha Schilling, MD MSHP, University of North Carolina, Chapel Hill
- Hovedetterforsker: Yasamin Sanii, MD, University of North Carolina, Chapel Hill
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-3652
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .