- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07656220
An Acceptance and Commitment Therapy Psychoeducation Single Session Intervention on Childhood Anxiety for Carers of Children With a Long-Term Health Condition
The goal of this feasibility study was to assess the acceptability and feasibility of the ACT-based training package for carers of children with a long-term health condition (LTHC) who also experience anxiety.
The main aims were to answer:
Is the intervention feasible? Is the intervention acceptable?
The secondary aim were to answer:
Does the intervention impact how carers approach and manage their child's anxiety?
Participants completed two questionnaires, prior to watching the online training videos. They were then asked to complete another questionnaire. Two weeks later, participants were contacted via email to complete two questionnaires, one of which was a repeat from prior to completing the training.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study aims to evaluate the feasibility and acceptability of a newly developed, single-session, online psychoeducational training designed to support caregivers in managing their child's anxiety associated with their long-term health condition (LTHC). The study also explored preliminary changes in caregiver knowledge and approaches to managing anxiety following the intervention.
This study used a quantitative, within-subjects feasibility design. Caregivers of children aged 5-12 years with a diagnosed long-term health condition were recruited. All participants received the intervention, with no control group.
The intervention consisted of a 22-minute online training package delivered via three videos. The content is based on ACT principles and includes psychoeducation about anxiety, ACT-based metaphors and exercises to consider using with their child. The material in the training was specifically designed to support children with a LTHC, rather than generic support for anxiety.
Participants completed measures prior to the intervention, including a demographic questionnaire and the Parent Attitudes, Beliefs and Understanding about Anxiety (PABUA). Immediately following the training, participants completed a structured feedback questionnaire assessing the acceptability and accessibility of the intervention. Two weeks after completing the training, participants were invited via email to complete follow-up measures, including a repeat of the PABUA and a follow-up feedback questionnaire to assess use and perceived usefulness of the strategies.
Feasibility outcomes include recruitment rates, retention rates, and participant-reported acceptability of the intervention and study procedures. Secondary outcomes include changes in caregiver knowledge, beliefs, and confidence in managing their child's anxiety (measured by the PABUA).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Norfolk
-
Norwich, Norfolk, Vereinigtes Königreich, NR4 7UJ
- University of East Anglia (UEA)
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Primary care giver of children aged 5-12 years
- The child has a long term health condition (LTHC)
Exclusion Criteria:
- Carers of children with a learning disability or waiting for an assessment for a learning disability, not including ADHD or dyslexia. This does however include Autism.
- Participants must be over 18
- Access to their own electronic device
- Not have sufficient proficiency in spoken English
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Single Group
All participants completed the intervention package.
The intervention was made up of 3 online training videos lasted a total of 22 minutes.
|
The intervention was made up of 3 videos, totalling 22 minutes.
The videos incorporated psychoeducation on anxiety and Acceptance and Commitment Therapy (ACT) based skills for carers to consider using to support their child with anxiety.
All material was based on children with long term health conditions.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Structured Feedback Questionnaire
Zeitfenster: Immediately post-intervention
|
Measure to assess the acceptability and feasibility of the training, for example assessing the consent process and format of the training.
The measure uses a scale of strongly disagree (1) to strongly agree (5).
|
Immediately post-intervention
|
|
Follow-up Structured Feedback Questionnaire
Zeitfenster: 2-week follow-up
|
Measure to assess barriers to engaging with the strategies since the training and reviewing usefulness of the strategies used.
The measure uses a scale of strongly disagree (1) to strongly agree (5).
|
2-week follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Parent, Attitudes, Beliefs and Understanding about Anxiety (PABUA) (Wolk et al, 2016)
Zeitfenster: Pre-intervention and 2-week follow-up
|
The measure was designed to evaluate parental beliefs about their child's anxiety, as well as their perceived ability to cope and manage their child's anxiety.
The measure uses a scale of strongly disagree (1) to strongly agree (5).
|
Pre-intervention and 2-week follow-up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Kiki Mastroyannopoulou, Senior Fellow of HEA, University of East Anglia (UEA)
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Harriet Leader-White
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Psychoeducation for anxiety
-
Hospices Civils de LyonUnbekannt
-
Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Duke University; Montefiore Medical... und andere MitarbeiterAbgeschlossenDepressionVereinigte Staaten
-
Boston Medical CenterBreast Cancer AllianceZurückgezogen
-
Institut de Cancérologie de la LoireAbgeschlossen
-
Forendo Pharma LtdRichmond Pharmacology LimitedAbgeschlossenRelative BioverfügbarkeitVereinigtes Königreich
-
Karadeniz Technical UniversityOnur Yilmaz; Pinar SivrikayaAbgeschlossenZahnarztangst | Timing in der Zahnarzt-Patienten-KommunikationTruthahn
-
Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Abgeschlossen
-
Centre Hospitalier Universitaire de Saint EtienneRekrutierungDepressionen, Angst | Generalisierte Angst | Überlebende von Krebs im Kindesalter | Introspektive und angstanfällige PatientinFrankreich
-
Universidad Miguel Hernandez de ElcheAktiv, nicht rekrutierendDepression | Stimmungsschwankungen | Angststörungen | Emotionale Störung | Depressive Symptome | Angststörungen und SymptomeSpanien
-
Forendo Pharma LtdRichmond Pharmacology LimitedAbgeschlossenEndometrioseVereinigtes Königreich