An interventional study of Parent-Based Treatment of Child and Adolescent Anxiety Disorders and CBT in Anxiety Disorders, Anxiety, Separation and Phobic Disorders, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 7 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.
Despite strong evidence for the efficacy of individual cognitive-behavior therapy (ICBT) for childhood anxiety disorders, up to 50% of children remain symptomatic after treatment and many still meet diagnostic criteria. Evidence for parental influences in the etiology and maintenance of anxiety in children has often led to the reasonable assumption that adding parent work to ICBT would enhance treatment effects. This idea has now been repeatedly tested in randomized controlled trials (RCTs) that compared ICBT to ICBT with added parent work. The specific content of the parent work has varied but has mainly included teaching parents skills for contingency management, modeling appropriate behavior, and reducing family conflict. Working with parents in these ways has so far not led to enhanced treatment effects compared to ICBT alone, as a number of meta-analytic and comprehensive reviews have shown.
One plausible conclusion from these data is that parent work cannot enhance effects beyond what is achieved through ICBT alone. This study focuses on an alternative plausible conclusion: That parent interventions need to be informed by theoretical working models of parent-specific mechanisms of change that are not targeted in ICBT; and that parent interventions need to be evaluated in explanatory RCTs that ask not only 'does treatment work?' but also 'how and for whom does treatment work?' Underlying systems that shape how parents respond to child anxiety or distress can provide clues to parent-specific targets for intervention and can point to potential moderators of treatment response. Identifying mechanisms by which parent interventions can enhance child anxiety outcomes, and identifying markers of parents most in need of such interventions advances the goal of personalized psychotherapy, and is the overall goal of this study.
Family accommodation (FA) describes parents' attempts to help a child avoid feeling anxious by participating in symptom-driven behaviors and modifying family routines. FA is highly prevalent among parents of anxious children and has been linked to greater symptom severity in the child and to poorer response to ICBT. Research has linked a number of biological and behavioral parent markers to protective parental behavior and to child anxiety. The nonapeptide oxytocin (OT) is implicated in parental attachment and protective behavior in humans and animals. Coded behavioral observations link aspects of parental behavior (i.e., autonomy granting, over involvement, and sensitivity) to child anxiety. A number of studies also have shown that these biological and behavioral markers interact to predict anxiety outcomes in at-risk children. Yet so far this research has been siloed from intervention research and has not informed parent-based treatments, highlighting the need for clinical investigators equipped with the necessary skills to integrate multiple units of analysis into explanatory RCTs of novel interventions.
This study represents a fusion of clinical, biological and behavioral research through an explanatory RCT of a parent-based treatment focused on modifying parental responses to child anxiety and distress as a mediator of treatment outcome, and on biological and behavioral markers as possible moderators of treatment outcome. The intervention evaluated in this study (Supportive Parenting for Anxious Childhood Emotions; SPACE) aims to systematically reduce FA through a series of concrete manualized steps. This study is an integrated explanatory RCT of SPACE with the following 3 specific aims:
Aim 1 - Specificity: Does SPACE lead to significantly lower levels of FA compared to ICBT? Hypothesis: Levels of FA for parents in SPACE will be significantly lower after treatment than before treatment, as compared to parents of children in ICBT.
Aim 2 - Mediation: Does reducing FA lead to positive child outcomes? Hypothesis: Parents' reduced FA will be a significant mediator of positive child outcomes (i.e., reduced child anxiety).
Aim 3 - Moderation: Do key biological and behavioral markers (i.e., parental OT, autonomy granting, over involvement, sensitivity) moderate child outcomes? Hypothesis: Baseline levels of maternal OT, autonomy granting, over involvement, and sensitivity will be significant moderators of child outcomes (i.e., reducing child anxiety).
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Children:
Exclusion Criteria:
Children:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cognitive Behavioral Therapy
Behavioral: CBT
Parent-Based Treatment of Childhood and Adolescent Anxiety Disorders
Behavioral: Parent-Based Treatment of Child and Adolescent Anxiety Disorders
Supportive Parenting for Anxious Childhood Emotions
Also known as: SPACE
Cognitive Behavioral Therapy
Clinical Global Impression Scale Improvement and Severity
Clinician determined rating of illness
Time frame: After 12 weeks of treatment
Pediatric Anxiety Rating Scale
Clinician administered rating of child anxiety
Time frame: After 12 weeks of treatment
Screen for Childhood Anxiety Related Disorders
A self and parent report of child anxiety
Time frame: After 12 weeks of treatment
The record gives a start of Nov 2014, a primary completion of Nov 2018 and a completion of Nov 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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