A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
23. april 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Tehran, Iran, Islamisk Republik, 13333
- Rouzbeh Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Revised Children's Manifest Anxiety (RCMA)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Children's Depression Inventory (CDI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: [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)
Tidsramme: [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]
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Zahra Shahrivar, MD, Tehran University of Medical Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2008
Primær færdiggørelse (Faktiske)
1. maj 2009
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
16. januar 2012
Først indsendt, der opfyldte QC-kriterier
19. januar 2012
Først opslået (Skøn)
20. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Parent CBT for Anxiety
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .