Separation Anxiety DisorderPhase 2NCT00593515
Effects of Parental Behavior on Child Anxiety Regulation
A Phase 2 study testing Family cognitive behavioral therapy and Child-focused cognitive behavioral therapy in people with Separation Anxiety Disorder and Social Phobia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Does parenting style affect emotion regulation among children who initially demonstrate high levels of fear and anxiety? Although recent correlational research has demonstrated a linkage between parental behaviors, such as excessive intrusiveness, and children's manifestations of fear and anxiety, it is not clear if… Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder
- What is being tested?
- Family cognitive behavioral therapy and Child-focused cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Apr 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child met DSM-IV criteria for a diagnosis of a principal anxiety disorder based on a semi-structured interview
- The child was not taking any psychiatric medication at the initial assessment, or was taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment), and
- If medication was being used, families stated an intention to maintain that dose throughout the study.
Who cannot join
- The child was currently in child-focused psychotherapy
- The family was currently in family therapy or a parenting class
- Either the child or the parents evidenced psychotic symptoms
- The child began taking psychiatric medication or increased his/her dose of medication during the intervention, or
- For any reason the child or parents appeared unable to participate in the intervention program.
Trial locations and contacts
1 site in 1 country.
About this study
Does parenting style affect emotion regulation among children who initially demonstrate high levels of fear and anxiety? Although recent correlational research has demonstrated a linkage between parental behaviors, such as excessive intrusiveness, and children's manifestations of fear and anxiety, it is not clear if parenting behaviors directly influence children's ability to regulate these emotions. Alternatively, these parental behaviors may be elicited by children who express fears and anxieties more frequently than other children do. Experimental research designs would offer a more definitive test of these competing explanations of the extant correlational findings. Intervention studies, in particular, can test whether experimentally manipulating current family interaction patterns affects children's ability to regulate emotion. This study provides a preliminary experimental test of the relationship between parental behavior and children's regulation of fear and anxiety. Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention program for childhood anxiety problems, which includes extensive parent communication training, or a child intervention program without parent-training. By comparing these two interventions, we tested if it was possible to improve parenting behaviors-such as intrusiveness-through intensive parent-training, above and beyond the effects of involving children in a child intervention program. We then tested the impact of this change in parental behaviors on children's ability to regulate fear and anxiety. We hypothesized that parent-training would reduce intrusiveness, which would in turn improve children's anxiety outcomes.
- Being tested
- Family cognitive behavioral therapy, Child-focused cognitive behavioral therapy
- Medical subject headings
- Anxiety, Separation, Phobia, Social, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family cognitive behavioral therapyBehavioural
12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each
Child-focused cognitive behavioral therapyBehavioural
12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Family CBT Receives: Behavioral: Family cognitive behavioral therapy |
| 2 | Active comparator | Child-focused CBT Receives: Behavioral: Child-focused cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule--Child and Parent Versions
Measured: Posttreatment
Secondary outcomes (1)
Multidimension Anxiety Scale for Children
Measured: Posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startMar 2000
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Separation Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Jeffrey Wood, Ph.D., Principal investigator, University of California, Los AngelesMarian Sigman, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593515
- Sponsor's protocol ID
- 1F31MH064999
- Status last verified
- Jan 2008
- First submitted
- 3 Jan 2008
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Wood JJ, Piacentini JC, Southam-Gerow M, Chu BC, Sigman M. Family cognitive behavioral therapy for child anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2006 Mar;45(3):314-321. doi: 10.1097/01.chi.0000196425.88341.b0.
PubMed 16540816
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parental Behavior on Child Anxiety Regulation
- ClinicalTrials.gov ID
- NCT00593515
- Acronym / sponsor ID
- 1F31MH064999
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2000
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does parenting style affect emotion regulation among children who initially demonstrate high levels of fear and anxiety? Although recent correlational research has demonstrated a linkage between parental behaviors, such as excessive intrusiveness, and children's manifestations of fear and anxiety, it is not clear if parenting behaviors directly influence children's ability to regulate these emotions. Alternatively, these parental behaviors may be elicited by children who express fears and anxieties more frequently than other children do. Experimental research designs would offer a more definitive test of these competing explanations of the extant correlational findings. Intervention studies, in particular, can test whether experimentally manipulating current family interaction patterns affects children's ability to regulate emotion. This study provides a preliminary experimental test of the relationship between parental behavior and children's regulation of fear and anxiety. Some 40 clinically anxious youth, aged 6-13, were randomly assigned to a family intervention program for childhood anxiety problems, which includes extensive parent communication training, or a child intervention program without parent-training. By comparing these two interventions, we tested if it was possible to improve parenting behaviors-such as intrusiveness-through intensive parent-training, above and beyond the effects of involving children in a child intervention program. We then tested the impact of this change in parental behaviors on children's ability to regulate fear and anxiety. We hypothesized that parent-training would reduce intrusiveness, which would in turn improve children's anxiety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Family cognitive behavioral therapyFamily CBT |
| 2 | Active comparator | Behavioral: Child-focused cognitive behavioral therapyChild-focused CBT |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child met DSM-IV criteria for a diagnosis of a principal anxiety disorder based on a semi-structured interview
- The child was not taking any psychiatric medication at the initial assessment, or was taking a stable dose of psychiatric medication (i.e., at least one month at a stable dose prior to the baseline assessment), and
- If medication was being used, families stated an intention to maintain that dose throughout the study.
Key exclusion criteria (5 listed)
- The child was currently in child-focused psychotherapy
- The family was currently in family therapy or a parenting class
- Either the child or the parents evidenced psychotic symptoms
- The child began taking psychiatric medication or increased his/her dose of medication during the intervention, or
- For any reason the child or parents appeared unable to participate in the intervention program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family cognitive behavioral therapy12-16 weekly sessions of family cognitive behavioral therapy, 60-80 minutes each | Behavioural | 1 |
| Child-focused cognitive behavioral therapy12-16 weekly sessions of child-focused cognitive behavioral therapy, 60-80 minutes each | Behavioural | 2 |
Primary outcome
Anxiety Disorders Interview Schedule--Child and Parent Versions
Time frame: Posttreatment
1 secondary outcome
Multidimension Anxiety Scale for Children
Time frame: Posttreatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
- Results publication: PubMed 16540816Wood JJ, Piacentini JC, Southam-Gerow M, Chu BC, Sigman M. Family cognitive behavioral therapy for child anxiety disorders. J Am Acad Child Adolesc Psychiatry. 2006 Mar;45(3):314-321. doi: 10.1097/01.chi.0000196425.88341.b0.
Related trials for Separation Anxiety Disorder
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Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation
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Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders
Active, not recruiting
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
Obsessive Compulsive Disorder (OCD), Anxiety Disorder of Childhood or Adolescence
Active, not recruitingPhase 3
Partners in Caring for Anxious Youth
Anxiety, Separation, Anxiety, Generalized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Wood, Ph.D. principal investigator
University of California, Los Angeles
Marian Sigman, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Family cognitive behavioral therapy and Child-focused cognitive behavioral therapy in people with Separation Anxiety Disorder and Social Phobia, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Disorders Interview Schedule--Child and Parent Versions (time frame: Posttreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00593515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2008.