A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
23. dubna 2016 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Tehran, Írán, Islámská republika, 13333
- Rouzbeh Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
6 let až 18 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
- age 6 to 12 years,
- 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,
- at least one parent willing to participate and give written consent.
Exclusion Criteria:
- diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
- there was a change in drug regime during the study period,
- if parents missed more than 2 of 6 sessions of treatment.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
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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.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Revised Children's Manifest Anxiety (RCMA)
Časové okno: up to 30 minutes
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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.
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up to 30 minutes
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Children's Depression Inventory (CDI)
Časové okno: 20 minutes
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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
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20 minutes
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Depression-Anxiety-Stress Scale (DASS)
Časové okno: 20 minutes
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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
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20 minutes
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Children Global Assessment Scale (CGAS)
Časové okno: 15 minutes
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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
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15 minutes
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Assessment of Consumer Satisfaction
Časové okno: 25 minutes
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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
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25 minutes
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Strengths and Difficulties Questionnaire (SDQ) Home Version
Časové okno: [Time Frame: 30 minutes]
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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
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[Time Frame: 30 minutes]
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Global Relational Assessment of Functioning (GRAF)
Časové okno: [Time Frame: 15 minutes]
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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
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[Time Frame: 15 minutes]
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Studijní židle: Zahra Shahrivar, MD, Tehran University of Medical Sciences
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2008
Primární dokončení (Aktuální)
1. května 2009
Dokončení studie (Aktuální)
1. července 2009
Termíny zápisu do studia
První předloženo
16. ledna 2012
První předloženo, které splnilo kritéria kontroly kvality
19. ledna 2012
První zveřejněno (Odhad)
20. ledna 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
26. dubna 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
23. dubna 2016
Naposledy ověřeno
1. dubna 2016
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Parent CBT for Anxiety
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