- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Norfolk
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Norwich, Norfolk, Regno Unito, NR4 7UJ
- University of East Anglia (UEA)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Single Group
All participants completed the intervention package.
The intervention was made up of 3 online training videos lasted a total of 22 minutes.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Structured Feedback Questionnaire
Lasso di tempo: Immediately post-intervention
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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).
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Immediately post-intervention
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Follow-up Structured Feedback Questionnaire
Lasso di tempo: 2-week follow-up
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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).
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2-week follow-up
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Parent, Attitudes, Beliefs and Understanding about Anxiety (PABUA) (Wolk et al, 2016)
Lasso di tempo: Pre-intervention and 2-week follow-up
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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).
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Pre-intervention and 2-week follow-up
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Kiki Mastroyannopoulou, Senior Fellow of HEA, University of East Anglia (UEA)
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Harriet Leader-White
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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