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A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study

23 aprile 2016 aggiornato da: Zahra Shahrivar, Tehran University of Medical Sciences

A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study

The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for children with anxiety disorders (AD) is undeniable. However, most children with AD have limited access to CBT. There is some controversial evidence on group CBT in AD involving families in treatment of their children and a published article on efficacy of a parent only group CBT for these children. Considering these data, the investigators hypothesized that teaching anxiety-fighting skills to parents of children with AD would diminish anxiety symptoms of both parents and children and improve family relational functioning.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

All children and their parents were interviewed using K-SADS-PL-Persian Version, a semi-structured diagnostic interview to confirm the diagnoses and assess possible comorbidities. All diagnostic assessments were conducted by a fellowship of child and adolescent psychiatry. Following assessment, once the participants reached twenty members, they were invited to complete child and parent self-report measures. The level of child functioning and family relationship functioning were also evaluated. Then they were randomly allocated to either parent training (N=20) or a 6 week wait-list (N=22) groups. During 2 weeks after treatment the assessments were repeated and satisfaction ratings were collected for the intervention group.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
  2. age 6 to 12 years,
  3. receiving one of selective serotonin reuptake inhibitor (SSRI) medicine at the stable dose for at least 8 weeks before baseline assessments and during the study,
  4. at least one parent willing to participate and give written consent.

Exclusion Criteria:

  1. diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
  2. there was a change in drug regime during the study period,
  3. if parents missed more than 2 of 6 sessions of treatment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: A parent only group CBT
There was a Group cognitive behavioral intervention -based on parent training component of "FRIENDS" program- for parents of children with anxiety disorders who were allocated to intervention group.
A Group cognitive behavioral intervention _based on parent training component of FRIENDS program_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions. Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.
Nessun intervento: Waiting list group
Parents of children with anxiety disorders who met the inclusion criteria and gave written informed consent and were allocated to wait list group.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Revised Children's Manifest Anxiety (RCMA)
Lasso di tempo: up to 30 minutes
This self report questionnaire consists of 28 items assessing a child's chronic or trait anxiety and 9 items assessing social desirability or potential lying. The RCMA has achieved a high internal consistency and moderate test-retest reliability.
up to 30 minutes

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Children's Depression Inventory (CDI)
Lasso di tempo: 20 minutes
This self report inventory has 27 items related to the cognitive, affective and behavioral signs of depression. The scale has high internal consistency and moderate test-retest reliability
20 minutes
Depression-Anxiety-Stress Scale (DASS)
Lasso di tempo: 20 minutes
This is a 42 item self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. The DASS was shown to possess satisfactory psychometric properties.45-47 Parents completed this scale about their own negative emotional states
20 minutes
Children Global Assessment Scale (CGAS)
Lasso di tempo: 15 minutes
This Scale was developed to be a more child-specific measure of functioning. This measure is currently used in diagnosis, treatment, and evaluation of children's mental health problems to determine eligibility to receive mental health services and document treatment outcome status
15 minutes
Assessment of Consumer Satisfaction
Lasso di tempo: 25 minutes
Post treatment, parents in the intervention group completed a satisfaction questionnaire to rate how useful the program was in controlling their own anxiety, in managing their child anxious behavior, in improving family relations, the likelihood they would attend the treatment program again if needed, and if they would recommend the program to others on a 1 (not recommend) to 7 (highly recommend) likert scale
25 minutes
Strengths and Difficulties Questionnaire (SDQ) Home Version
Lasso di tempo: [Time Frame: 30 minutes]
This questionnaire is a parent report of psychopathology in children and adolescents. The scale consists of 25 items which generates five subscale scores (Emotional Symptoms, Conduct Problems, Inattention/Hyperactivity, Peer Problems and Prosocial Behavior) and a Total Difficulties Score. We used the SDQ Emotional Symptoms Scale (SDQ-Em) as a parent measure of child anxiety. SDQ has adequate internal consistency (α=0.37) and good test-retest reliability (r=0.62).42-44 The validity and reliability of SDQ has been confirmed in community samples of Iranian children and adolescents
[Time Frame: 30 minutes]
Global Relational Assessment of Functioning (GRAF)
Lasso di tempo: [Time Frame: 15 minutes]
It provides a measure of the quality of functioning based on a review of three major areas: problem-solving, organization, and the emotional atmosphere. Available psychometric evidence suggests that clinician and even non clinician raters can achieve good to excellent reliability with only minimal training. The validity of the GRAF is supported by expected correlations with other measures of family and couple distress and functioning
[Time Frame: 15 minutes]

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Zahra Shahrivar, MD, Tehran University of Medical Sciences

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2008

Completamento primario (Effettivo)

1 maggio 2009

Completamento dello studio (Effettivo)

1 luglio 2009

Date di iscrizione allo studio

Primo inviato

16 gennaio 2012

Primo inviato che soddisfa i criteri di controllo qualità

19 gennaio 2012

Primo Inserito (Stima)

20 gennaio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 aprile 2016

Ultimo verificato

1 aprile 2016

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Parent CBT for Anxiety

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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