Child AbuseCAPSNCT02684903
Coaching Alternative Parenting Strategies (CAPS) Study
A study testing Parent Child Interaction Therapy in people with Child Abuse and Self-control, run by University of Oregon at 1 site in United States.
Trial summary
This is a randomized, controlled trial (RCT) of Parent-Child Interaction Therapy (PCIT) designed to test the effects of PCIT on self-regulation and behavior in child maltreating (CM) parents and their elementary-school children. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Child Abuse, Self-control, Parenting
- What is being tested?
- Parent Child Interaction Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident of Lane County
- Parent is 18 or older
- Biological or custodial mother of a child between age 3 and 7 years at baseline
- Resides in the same home setting with the child
- Must be fluent in English
- Mom and child must be physically able to complete the assessment
- Family has an open case with Lane County Dept. Health Services.
Who cannot join
- Child sexual abuse in the family
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coaching Alternative Parenting Strategies (CAPS) Study: Targeting Neurobiological and Behavioral Mechanisms of Self-regulation in High-risk Families
This is a randomized, controlled trial (RCT) of Parent-Child Interaction Therapy (PCIT) designed to test the effects of PCIT on self-regulation and behavior in child maltreating (CM) parents and their elementary-school children. Two hundred-fifty (250) maltreating mothers and their children (age 5-8 years) will be drawn from Child Protective Services and randomized to the PCIT intervention or a control condition (services as usual). Key contextual risk factors will be assessed, including cumulative risk, parent mental health, and parent substance use. A multirater, multimethod approach to assessment will include measures of self-regulation, parenting skills and children's behavior outcomes. Families will be followed to 1 year for CM recidivism. Findings from this proposed study are expected to have significant implications for optimizing CM parenting interventions by (a) determining the sensitivity of CM parent and child neurobehavioral self-regulation systems to intervention, and (b) identifying individual differences in self-regulation that mediate and moderate response to intervention and long-term maintenance of gains.
Read the detailed description
Child maltreatment (CM) constitutes a serious public health problem in the United States and is known to compromise children's developing self-regulation skills and amplify risk for substance use and other regulatory disorders. Parent-Child Interaction Therapy (PCIT), an intensive, 20-session parenting intervention, has been shown to improve the quality of CM parenting, improve positive parenting and child behavior, and produce declines in CM recidivism (Chaffin et al., 2004) though the mechanisms underlying its effects are little understood. This project addresses gaps in the CM intervention literature in that it (a) uses an experimental intervention design to test a theoretical model of change underlying PCIT's effects, (b) includes a battery of neurobehavioral measures of self-regulation, and (c) uses observational measures of parenting in an RCT of an evidence-based intervention for strengthening parent self-regulation, reducing CM, and supporting improvements in child regulation and behavior. Study aims are to:
Aim 1: Test the main effects of PCIT on CM-specific outcomes, including reductions in harsh, aversive parenting and CM recidivism and promotion of children's behavioral adjustment. It is hypothesized that intervention families will show significantly greater behavior improvements (i.e., decreased negative parenting, increased positive parenting, and decreased child internalizing/externalizing problems) at posttest and lower CM recidivism at 6-month follow-up, compared to families receiving services as usual (SAU).
Specific Aim 2: Determine the impact of PCIT on indices of CM parents' self-regulation. First, the investigators will test the hypothesis that PCIT exerts direct effects on improving CM parents' capacities for self-regulation in the context of parenting. Second, the investigators will investigate how measures of self-regulation in parents mediate PCIT intervention effects on reductions in CM and improvements in parenting. Third, the investigators will explore whether parents' preintervention self-regulation levels moderate intervention effects on outcomes. The moderating roles of CM subtype (i.e., physical abuse vs. neglect), severity, and other key sociocontextual factors on the outcomes of interest also will be considered.
Specific Aim 3: Investigate the impact of PCIT on neurobehavioral indices of CM children's self-regulation. CM exerts detrimental effects on children's developing capacities to regulate attention, emotion, physiology, and behavior. Deficits in these domains confer heightened risk for psychopathology, early-onset conduct problems, and later substance abuse. The investigators hypothesize that PCIT, though directed primarily toward parenting, will effect improvements in neurobiological indicators of CM children's self-regulation at post-treatment, relative to the control group. Next, the investigators will test the extent to which child outcomes are mediated through intervention effects on parenting. It is hypothesized that child regulatory deficits and behavior problems will be attenuated by PCIT-based reductions in aversive parenting that result from the intervention.
- Conditions
- Child Abuse, Self-control, Parenting
- Being tested
- Parent Child Interaction Therapy
- Keywords
- Child Abuse, Parent Child Interaction Therapy (PCIT), Evidenced Based Intervention, Self-control
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Child Interaction TherapyBehavioural
Also called PCIT
PCIT is a 16-20 session live-coaching parenting intervention. PCIT for Child Welfare families is delivered in two sequential treatment phases following a motivational enhancement training: Phase 1, Child-Directed Interaction (CDI) to enhance positive parenting and interrupt harsh aversive parenting, and Phase 2, Parent-Directed Interaction (PDI) to coach effective parent commands and a consistent time-out protocol when child disobeys.
| Study group | Role | What they receive |
|---|---|---|
| Services As Usual (SAU) | No intervention | Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services. |
| Parent Child Interaction Therapy (PCIT) | Experimental | Participants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills.
. Receives: Behavioral: Parent Child Interaction Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DPICS-IV Observed Parenting Skills (During Child-Led Play)
Dyadic Parent-Child Interaction Coding System (DPICS) coded positive "PRIDE" parenting skills and negative "Don't skills" parenting behaviors during the DPICS Child-Led Play task. Scores reflect behavioral counts during the 5-minute task, with higher scores reflecting more behaviors. Higher positive parenting scores reflect better outcomes, whereas higher negative parenting scores reflect worse outcomes.
Measured: Pre- and Post-intervention (8 months)
DPICS-IV Observational Coding During Clean Up Situation Task
DPICS-Coded Positive "PRIDE" Parenting skills, Effective Parent Commands, and Child Compliance behaviors during the DPICS Clean Up Situation task. Positive parenting scores reflect the percentage of total coded behaviors during the task that are positive "PRIDE" skills. Effective (direct) parent commands reflect the percentage of all commands that were direct, compliable commands. Child compliance scores reflected the percentage of effective, direct commands that child complied with in the immediately following behavioral turn. High scores on all three scales reflect better outcomes.
Measured: Pre- and Post-intervention (8 months)
Stop Signal Task: Increased Parent Inhibitory Control
The Stop Signal Response Time (SSRT) was used to assess the efficiency of parent inhibitory control process or time in milliseconds needed to engage an inhibitory response. Lower SSRT scores reflect faster reaction times and better inhibitory control.
Measured: pre- and post-intervention (8 months)
Secondary outcomes (1)
Reduced Child Maltreatment (CM) Recidivism
Fewer new episodes of CM per Maltreatment Classification Coding of Child Welfare case records
Measured: up to 1 year posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2020
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (169)Papers the sponsor has linked to this study.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Skowron, University of Oregon
- Investigators
- Elizabeth A Skowron, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684903
- Sponsor's protocol ID
- 1R01DA036533-01A1
- Acronym
- CAPS
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2016
- Last updated
- 2 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aber JL, Cicchetti D. The social-emotional development of maltreated children: An empirical and theoretical analysis. In H. Fitzgerald, B. Lester, & M. Yogman (Eds.), Theory and research in behavioral pediatrics (Vol. 2, pp. 147-205). New York, NY: Plenum, 1984.
Abidin RR. Parenting Stress Index (3rd ed.). Odessa, FL: Psychological Assessment Resources, 1995.
Achenbach TM, Rescorla LA. Manual for the ASEBA School-Age Forms and Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, and Families, 2001.
Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
PubMed 11129362Alkon A, Goldstein LH, Smider N, Essex MJ, Kupfer DJ, Boyce WT. Developmental and contextual influences on autonomic reactivity in young children. Dev Psychobiol. 2003 Jan;42(1):64-78. doi: 10.1002/dev.10082.
PubMed 12471637Anderson TW, Amemiya Y. The asymptotic normal distribution of estimators in factor analysis under general conditions. The Annals of Statistics 16(2): 759-771, 1988.
Aos S, Lee S, Drake E, Pennucci A, Klima T, Miller M, Anderson L, Mayfield J, Burley M. Return on investment: Evidence-based options to improve statewide outcomes (Document No. 11-07-1201). Olympia: Washington State Institute for Public Policy, 2011.
Barnett D, Manly JT, Cicchetti D. Defining child maltreatment: The interface between policy and research. In D. Cicchetti & S. L. Toth (Eds.), Child abuse, child development, and social policy (pp. 7-73). Norwood, NJ: Ablex, 1993.
Bäumler G.Farb-Wort-Interferenztest (FWIT) nach J.R. Stroop. Göttingen: Hogrefe, 1985.
Beauchaine T. Vagal tone, development, and Gray's motivational theory: toward an integrated model of autonomic nervous system functioning in psychopathology. Dev Psychopathol. 2001 Spring;13(2):183-214. doi: 10.1017/s0954579401002012.
PubMed 11393643Beauchaine TP, Gatzke-Kopp L, Mead HK. Polyvagal Theory and developmental psychopathology: emotion dysregulation and conduct problems from preschool to adolescence. Biol Psychol. 2007 Feb;74(2):174-84. doi: 10.1016/j.biopsycho.2005.08.008. Epub 2006 Oct 12.
PubMed 17045726Beauchaine TP, Neuhaus E, Brenner SL, Gatzke-Kopp L. Ten good reasons to consider biological processes in prevention and intervention research. Dev Psychopathol. 2008 Summer;20(3):745-74. doi: 10.1017/S0954579408000369.
PubMed 18606030Beckett LA, Tancredi DJ, Wilson RS. Multivariate longitudinal models for complex change processes. Stat Med. 2004 Jan 30;23(2):231-9. doi: 10.1002/sim.1712.
PubMed 14716725Belsky J. Etiology of child maltreatment: a developmental-ecological analysis. Psychol Bull. 1993 Nov;114(3):413-34. doi: 10.1037/0033-2909.114.3.413.
PubMed 8272464Berger A. Neurocognitive and neuromotivational mechanisms of self-regulation. In A. Berger (Ed.), Self-regulation: Brain, cognition, and development. Human brain development series, (pp. 19-44). Washington, DC: American Psychological Association, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching Alternative Parenting Strategies (CAPS) Study: Targeting Neurobiological and Behavioral Mechanisms of Self-regulation in High-risk Families
- ClinicalTrials.gov ID
- NCT02684903
- Acronym / sponsor ID
- CAPS / 1R01DA036533-01A1
- Conditions
- Child Abuse, Self-control, Parenting
- Keywords
- Child Abuse, Parent Child Interaction Therapy (PCIT), Evidenced Based Intervention, Self-control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Posted 2 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial (RCT) of Parent-Child Interaction Therapy (PCIT) designed to test the effects of PCIT on self-regulation and behavior in child maltreating (CM) parents and their elementary-school children. Two hundred-fifty (250) maltreating mothers and their children (age 5-8 years) will be drawn from Child Protective Services and randomized to the PCIT intervention or a control condition (services as usual). Key contextual risk factors will be assessed, including cumulative risk, parent mental health, and parent substance use. A multirater, multimethod approach to assessment will include measures of self-regulation, parenting skills and children's behavior outcomes. Families will be followed to 1 year for CM recidivism. Findings from this proposed study are expected to have significant implications for optimizing CM parenting interventions by (a) determining the sensitivity of CM parent and child neurobehavioral self-regulation systems to intervention, and (b) identifying individual differences in self-regulation that mediate and moderate response to intervention and long-term maintenance of gains.
Detailed description
Child maltreatment (CM) constitutes a serious public health problem in the United States and is known to compromise children's developing self-regulation skills and amplify risk for substance use and other regulatory disorders. Parent-Child Interaction Therapy (PCIT), an intensive, 20-session parenting intervention, has been shown to improve the quality of CM parenting, improve positive parenting and child behavior, and produce declines in CM recidivism (Chaffin et al., 2004) though the mechanisms underlying its effects are little understood. This project addresses gaps in the CM intervention literature in that it (a) uses an experimental intervention design to test a theoretical model of change underlying PCIT's effects, (b) includes a battery of neurobehavioral measures of self-regulation, and (c) uses observational measures of parenting in an RCT of an evidence-based intervention for strengthening parent self-regulation, reducing CM, and supporting improvements in child regulation and behavior. Study aims are to:
Aim 1: Test the main effects of PCIT on CM-specific outcomes, including reductions in harsh, aversive parenting and CM recidivism and promotion of children's behavioral adjustment. It is hypothesized that intervention families will show significantly greater behavior improvements (i.e., decreased negative parenting, increased positive parenting, and decreased child internalizing/externalizing problems) at posttest and lower CM recidivism at 6-month follow-up, compared to families receiving services as usual (SAU).
Specific Aim 2: Determine the impact of PCIT on indices of CM parents' self-regulation. First, the investigators will test the hypothesis that PCIT exerts direct effects on improving CM parents' capacities for self-regulation in the context of parenting. Second, the investigators will investigate how measures of self-regulation in parents mediate PCIT intervention effects on reductions in CM and improvements in parenting. Third, the investigators will explore whether parents' preintervention self-regulation levels moderate intervention effects on outcomes. The moderating roles of CM subtype (i.e., physical abuse vs. neglect), severity, and other key sociocontextual factors on the outcomes of interest also will be considered.
Specific Aim 3: Investigate the impact of PCIT on neurobehavioral indices of CM children's self-regulation. CM exerts detrimental effects on children's developing capacities to regulate attention, emotion, physiology, and behavior. Deficits in these domains confer heightened risk for psychopathology, early-onset conduct problems, and later substance abuse. The investigators hypothesize that PCIT, though directed primarily toward parenting, will effect improvements in neurobiological indicators of CM children's self-regulation at post-treatment, relative to the control group. Next, the investigators will test the extent to which child outcomes are mediated through intervention effects on parenting. It is hypothesized that child regulatory deficits and behavior problems will be attenuated by PCIT-based reductions in aversive parenting that result from the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Services As Usual (SAU) | No intervention | –Participants receive all the usual services provided by Department of Human Services (DHS) Children's Services. |
| Parent Child Interaction Therapy (PCIT) | Experimental | Behavioral: Parent Child Interaction TherapyParticipants receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. . |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Resident of Lane County
- Parent is 18 or older
- Biological or custodial mother of a child between age 3 and 7 years at baseline
- Resides in the same home setting with the child
- Must be fluent in English
Key exclusion criteria (1 listed)
- Child sexual abuse in the family
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 |
|---|---|---|
| Parent Child Interaction TherapyAlso: PCITPCIT is a 16-20 session live-coaching parenting intervention. PCIT for Child Welfare families is delivered in two sequential treatment phases following a motivational enhancement training: Phase 1, Child-Directed Interaction (CDI) to enhance positive parenting and interrupt harsh aversive parenting, and Phase 2, Parent-Directed Interaction (PDI) to coach effective parent commands and a consistent time-out protocol when child disobeys. | Behavioural | Parent Child Interaction Therapy (PCIT) |
Primary outcome
DPICS-IV Observed Parenting Skills (During Child-Led Play)
Time frame: Pre- and Post-intervention (8 months)
Dyadic Parent-Child Interaction Coding System (DPICS) coded positive "PRIDE" parenting skills and negative "Don't skills" parenting behaviors during the DPICS Child-Led Play task. Scores reflect behavioral counts during the 5-minute task, with higher scores reflecting more behaviors. Higher positive parenting scores reflect better outcomes, whereas higher negative parenting scores reflect worse outcomes.
DPICS-IV Observational Coding During Clean Up Situation Task
Time frame: Pre- and Post-intervention (8 months)
DPICS-Coded Positive "PRIDE" Parenting skills, Effective Parent Commands, and Child Compliance behaviors during the DPICS Clean Up Situation task. Positive parenting scores reflect the percentage of total coded behaviors during the task that are positive "PRIDE" skills. Effective (direct) parent commands reflect the percentage of all commands that were direct, compliable commands. Child compliance scores reflected the percentage of effective, direct commands that child complied with in the immediately following behavioral turn. High scores on all three scales reflect better outcomes.
Stop Signal Task: Increased Parent Inhibitory Control
Time frame: pre- and post-intervention (8 months)
The Stop Signal Response Time (SSRT) was used to assess the efficiency of parent inhibitory control process or time in milliseconds needed to engage an inhibitory response. Lower SSRT scores reflect faster reaction times and better inhibitory control.
1 secondary outcome
Reduced Child Maltreatment (CM) Recidivism
Time frame: up to 1 year posttreatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAber JL, Cicchetti D. The social-emotional development of maltreated children: An empirical and theoretical analysis. In H. Fitzgerald, B. Lester, & M. Yogman (Eds.), Theory and research in behavioral pediatrics (Vol. 2, pp. 147-205). New York, NY: Plenum, 1984.
- BackgroundAbidin RR. Parenting Stress Index (3rd ed.). Odessa, FL: Psychological Assessment Resources, 1995.
- BackgroundAchenbach TM, Rescorla LA. Manual for the ASEBA School-Age Forms and Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, and Families, 2001.
- Background: PubMed 11129362Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
- Background: PubMed 12471637Alkon A, Goldstein LH, Smider N, Essex MJ, Kupfer DJ, Boyce WT. Developmental and contextual influences on autonomic reactivity in young children. Dev Psychobiol. 2003 Jan;42(1):64-78. doi: 10.1002/dev.10082.
- BackgroundAnderson TW, Amemiya Y. The asymptotic normal distribution of estimators in factor analysis under general conditions. The Annals of Statistics 16(2): 759-771, 1988.
- BackgroundAos S, Lee S, Drake E, Pennucci A, Klima T, Miller M, Anderson L, Mayfield J, Burley M. Return on investment: Evidence-based options to improve statewide outcomes (Document No. 11-07-1201). Olympia: Washington State Institute for Public Policy, 2011.
- BackgroundBarnett D, Manly JT, Cicchetti D. Defining child maltreatment: The interface between policy and research. In D. Cicchetti & S. L. Toth (Eds.), Child abuse, child development, and social policy (pp. 7-73). Norwood, NJ: Ablex, 1993.
- BackgroundBäumler G.Farb-Wort-Interferenztest (FWIT) nach J.R. Stroop. Göttingen: Hogrefe, 1985.
- Background: PubMed 11393643Beauchaine T. Vagal tone, development, and Gray's motivational theory: toward an integrated model of autonomic nervous system functioning in psychopathology. Dev Psychopathol. 2001 Spring;13(2):183-214. doi: 10.1017/s0954579401002012.
- Background: PubMed 17045726Beauchaine TP, Gatzke-Kopp L, Mead HK. Polyvagal Theory and developmental psychopathology: emotion dysregulation and conduct problems from preschool to adolescence. Biol Psychol. 2007 Feb;74(2):174-84. doi: 10.1016/j.biopsycho.2005.08.008. Epub 2006 Oct 12.
- Background: PubMed 18606030Beauchaine TP, Neuhaus E, Brenner SL, Gatzke-Kopp L. Ten good reasons to consider biological processes in prevention and intervention research. Dev Psychopathol. 2008 Summer;20(3):745-74. doi: 10.1017/S0954579408000369.
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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.
Elizabeth A Skowron, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Child Interaction Therapy in people with Child Abuse and Self-control, run by University of Oregon 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 7 inclusion and 1 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 2 Nov 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
DPICS-IV Observed Parenting Skills (During Child-Led Play) (time frame: Pre- and Post-intervention (8 months)). The study lists 3 primary outcomes in all. 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 NCT02684903, which also lists 169 linked publications.
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 2 Nov 2023.