ParentingSMARTNCT05509348
SMART Optimization of a Parenting Program for Active-duty Families
A study testing Phase 1: ADAPT Workshop, Phase 1: ADAPT Online and Phase 2: ADAPT Group in people with Parenting, run by University of Minnesota at 4 sites in United States.
Trial summary
The overarching goal of the "SMART Optimization of a Parenting Program for Active-Duty Families" study is to advance the "development, adaptation, efficiency or optimization, and testing of a prevention intervention by using a sequential, multiple assignment, randomized trial/SMART to test multiple components of an… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Phase 1: ADAPT Workshop, Phase 1: ADAPT Online and Phase 2: ADAPT Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2017to 29 Sep 2022
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- families in which one parent has returned from deployment
- families with at least one child age 5 to 12 in their custody and living with parent(s) in the home
- must agree to randomization
- must indicate willingness to interact with study materials and complete assessment batteries
Who cannot join
- families with children younger than 5 or older than 12
- families in which at least one parent has an active psychosis
- families with an open child protection case for abuse or neglect in the family
- families in which there is a child with a serious mental health diagnosis (i.e., autism, child psychosis)
- youth who have a documented pervasive developmental disability or mental retardation
- families who participated in the focus group
- those with less than a 5th grade comprehension level in English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Fort Myer
Arlington, Virginia, 22211
Fort Belvoir
Fort Belvoir, Virginia, 22060
Fort Bragg
Fort Bragg, North Carolina, 28303
Fort Campbell
Fort Campbell North, Kentucky, 42223
About this study
The overarching goal of the "SMART Optimization of a Parenting Program for Active-Duty Families" study is to advance the "development, adaptation, efficiency or optimization, and testing of a prevention intervention by using a sequential, multiple assignment, randomized trial/SMART to test multiple components of an empirically-supported parent training prevention intervention - After Deployment Adaptive Parenting Tools (ADAPT) for active-duty families negotiating multiple deployments and high deployment OPTEMPO (an army program that provides critical responses).
Read the detailed description
Deployment (and particularly high deployment operational tempo/OPTEMPO) can generate family and personal stressors that disrupt supportive social relationships and functioning at home, thereby weakening the strength of military force in the field. Stressors include separation from, and reunification with families, concerns about mobilizations and combat stressors. These stressors, in turn, are associated with reduced parenting effectiveness, marital/partner difficulties, emotion dysregulation, and increased coercion. Coercion predicts risk for child maladjustment, as well as marital disruptions. Without effective prevention interventions, such environments may contribute to high divorce rates, child maladjustment, and reductions in service member wellbeing.
Most prevention interventions use a one-size-fits-all approach (i.e. all participants receive the same dose, format, and type of program) but this approach is often inefficient. Some families benefit from this approach but many do not. Adaptive interventions maximize efficiency, scalability, and sustainability, by providing families with a tailored dose, timing, program format, and/or sequence to improve outcomes based on their preferences and needs.
After Deployment: Adaptive Parenting Tools (ADAPT) is a Parent Management Training-Oregon (PMTO) program for military families with children ages 5-12 years old. PMTO is a theoretically-based family of interventions with extensive research supporting efficacy and effectiveness. ADAPT was developed and tested primary with National Guard/Reserve families. Program findings, based on 3 RCTs, indicate positive outcomes. No empirically supported parent training programs have been validated in RCTs for active duty military families with school-aged children in regular and high deployment OPTEMPO contexts.
The investigators are proposing a Phase III Clinical trial. The SMART optimization of a parenting program for active-duty families uses an adaptive intervention strategy to optimize an evidence-based universal prevention intervention, After Deployment Adaptive Parenting Tools/(ADAPT). SMART trials are rapidly gaining recognition within the medical and mental health fields as an innovative approach to developing adaptive treatment regimens. SMARTs have been successfully implemented in diverse areas including interventions for cancer, autism spectrum disorders, adolescent depression, and alcoholism. SMARTs also show considerable promise in innovating intervention approaches within prevention contexts.
In this study, the investigators will compress and test a variety of formats, sequences, and doses of ADAPT. The investigators will provide two 'first line' ADAPT programs and two slightly more intensive booster ADAPT programs for families who do not 'respond' to the first line intervention. Adaptive intervention strategies involve decision rules that specify how the type or intensity of an intervention should change depending on participants' response on a predetermined indicator of initial progress within an intervention. Within a SMART, a measure of initial response is used following delivery of an intervention in order to evaluate each families' need for further intervention programming. In this way, programming is tailored to meet the needs of individual families by providing additional services only to those families who are likely to benefit. This measure of initial response is referred to as a primary tailoring variable. In the proposed study, the primary tailoring variable is parental locus of control, a key variable shown in prior studies to predict change in observed parenting effectiveness, as well as change in other outcomes (PTSD symptoms, suicidality, and child adjustment).
The tested formats, sequences, and doses of ADAPT include:
- Begin with ADAPT Online. Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped-up to booster individual face-to-face ADAPT.
- Begin with ADAPT Online. Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped -up to booster group-based ADAPT.
- Begin with ADAPT condensed group (with online support). Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped to booster group-based ADAPT.
- Begin with ADAPT condensed group (with online support). Parents exhibiting initial response continue access to online resources. Parents exhibiting non-response are stepped-up to booster group-based ADAPT.
This approach allows families who do not need intensive services to receive appropriately brief services. Those higher-need families receive more intensive services.
To address Aim 1, the investigators will compress the ADAPT group and individual curriculum, through consultation with service members, spouse, and content experts. The investigators will conduct two focus groups with parents who have returned from deployment (including spouses) and live on military installations and will assemble a Panel of 7 experts via a video conference call to inform program modifications. Each of the two parent focus group will consist of 12 families (24 individuals), one group at Fort Bragg with Special Operations (SO) participants, one group at Joint Base Lewis-McChord (JBLM) and Ft. Campbell with 12 Regular Army (RA) participants. To ensure gender sensitivity, the investigators will recruit and ask similar questions of mothers and fathers.
The investigators will ask an Expert Panel to view and advise on modifications to the current ADAPT NG/R group and individual materials. After reviewing the report of the focus group results, an Expert Panel will gather via videoconference (Month 4). Panel experts will weigh in on the results and be provided with two weeks to provide written recommendations. Expert panel and focus group feedback will inform (i) how to best compress key ADAPT skills, and (ii) address issues specific to high deployment OPTEMPO conditions. The focus group data and panel feedback will be used to finalize components for the SMART.
To address Aims 2,3,4: Among 210 SO and 315 RA families (i.e., total N=525 families) with 5-12 year-old children, the investigators will examine effects of ADAPT modalities and sequences/timing on multiple behaviors and outcomes (i.e., (i) coercive family interactions, positive parenting, couple adjustment, and co-parenting, (ii) parents PTSD symptoms, depression symptoms, substance use, (iii) child behavior and emotional problems, and positive adjustment, by conducting a 2-stage SMART, and (iv) document participation, satisfaction, and fidelity. To assess behaviors and outcomes, the investigators will administer and collect a series of assessments at 4 timepoints.
For Aims 2, 3, and 4, the investigators will use a 2-stage SMART design to examine the optimal sequence, dosage, and delivery formats of ADAPT for active duty military families living in a range of operational tempo contexts. The investigators will recruit a total of 525 families living on three installations: FT Bragg, FTs Belvoir/Myer and FT Campbell, with 210 families recruited from FTs Bragg and Campbell, and 105 from FTs Belvoir/Myer.
- Conditions
- Parenting
- Being tested
- Phase 1: ADAPT Workshop, Phase 1: ADAPT Online, Phase 2: ADAPT Group, Phase 2: ADAPT Individual
- Keywords
- Parenting, Military Families, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1: ADAPT WorkshopBehavioural
2 day workshop
Phase 1: ADAPT OnlineBehavioural
Online curriculum
Phase 2: ADAPT GroupBehavioural
3 in person group sessions
Phase 2: ADAPT IndividualBehavioural
3 sessions in person one on one
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: ADAPT Workshop | Experimental | 2 - day long in-person workshops (7 hours each day). Workshops are 2 weeks apart. Receives: Behavioral: Phase 1: ADAPT Workshop |
| Phase 1: ADAPT Online | Experimental | 3 weeks are given to complete 12 online modules using a secure website. Online modules include skill video, practice video, summary sheets, mindfulness audio and exercise video, printable handouts and motivation questionnaire. Receives: Behavioral: Phase 1: ADAPT Online |
| Phase 2: ADAPT Group | Experimental | 3 - 2 hour long in-person group sessions. Group sessions are consecutive weeks. Receives: Behavioral: Phase 2: ADAPT Group |
| Phase 2: ADAPT Individual | Experimental | 3 - 1 1/2 hour in-person individual sessions. Sessions are consecutive weeks. Receives: Behavioral: Phase 2: ADAPT Individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Observed Parenting Effectiveness
Family Interaction Tasks (FIT) with each parent and child
Measured: T1 (baseline), T3 (1 year) and T4 (2 years). Change is being assessed, primarily change between T1 and T3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Jul 2017
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential multiple assignment randomization trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Abigail Gewirtz, PhD, Principal investigator, University of Minnesota and Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509348
- Sponsor's protocol ID
- STUDY00015375
- Other IDs
- CDMRP-PT150093
- Acronym
- SMART
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2019
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
PubMed 22438190Kasari C, Kaiser A, Goods K, Nietfeld J, Mathy P, Landa R, Murphy S, Almirall D. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):635-46. doi: 10.1016/j.jaac.2014.01.019. Epub 2014 Mar 12.
PubMed 24839882Thall PF, Logothetis C, Pagliaro LC, Wen S, Brown MA, Williams D, Millikan RE. Adaptive therapy for androgen-independent prostate cancer: a randomized selection trial of four regimens. J Natl Cancer Inst. 2007 Nov 7;99(21):1613-22. doi: 10.1093/jnci/djm189. Epub 2007 Oct 30.
PubMed 17971530Murphy SA, Lynch KG, Oslin D, McKay JR, TenHave T. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S24-30. doi: 10.1016/j.drugalcdep.2006.09.008. Epub 2006 Oct 23.
PubMed 17056207August GJ, Piehler TF, Bloomquist ML. Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency. J Clin Child Adolesc Psychol. 2016 Jul-Aug;45(4):495-509. doi: 10.1080/15374416.2014.945212. Epub 2014 Sep 25.
PubMed 25256135
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Optimization of a Parenting Program for Active-duty Families
- ClinicalTrials.gov ID
- NCT05509348
- Acronym / sponsor ID
- SMART / STUDY00015375
- Conditions
- Parenting
- Keywords
- Parenting, Military Families, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- 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.
The overarching goal of the "SMART Optimization of a Parenting Program for Active-Duty Families" study is to advance the "development, adaptation, efficiency or optimization, and testing of a prevention intervention by using a sequential, multiple assignment, randomized trial/SMART to test multiple components of an empirically-supported parent training prevention intervention - After Deployment Adaptive Parenting Tools (ADAPT) for active-duty families negotiating multiple deployments and high deployment OPTEMPO (an army program that provides critical responses).
Detailed description
Deployment (and particularly high deployment operational tempo/OPTEMPO) can generate family and personal stressors that disrupt supportive social relationships and functioning at home, thereby weakening the strength of military force in the field. Stressors include separation from, and reunification with families, concerns about mobilizations and combat stressors. These stressors, in turn, are associated with reduced parenting effectiveness, marital/partner difficulties, emotion dysregulation, and increased coercion. Coercion predicts risk for child maladjustment, as well as marital disruptions. Without effective prevention interventions, such environments may contribute to high divorce rates, child maladjustment, and reductions in service member wellbeing.
Most prevention interventions use a one-size-fits-all approach (i.e. all participants receive the same dose, format, and type of program) but this approach is often inefficient. Some families benefit from this approach but many do not. Adaptive interventions maximize efficiency, scalability, and sustainability, by providing families with a tailored dose, timing, program format, and/or sequence to improve outcomes based on their preferences and needs.
After Deployment: Adaptive Parenting Tools (ADAPT) is a Parent Management Training-Oregon (PMTO) program for military families with children ages 5-12 years old. PMTO is a theoretically-based family of interventions with extensive research supporting efficacy and effectiveness. ADAPT was developed and tested primary with National Guard/Reserve families. Program findings, based on 3 RCTs, indicate positive outcomes. No empirically supported parent training programs have been validated in RCTs for active duty military families with school-aged children in regular and high deployment OPTEMPO contexts.
The investigators are proposing a Phase III Clinical trial. The SMART optimization of a parenting program for active-duty families uses an adaptive intervention strategy to optimize an evidence-based universal prevention intervention, After Deployment Adaptive Parenting Tools/(ADAPT). SMART trials are rapidly gaining recognition within the medical and mental health fields as an innovative approach to developing adaptive treatment regimens. SMARTs have been successfully implemented in diverse areas including interventions for cancer, autism spectrum disorders, adolescent depression, and alcoholism. SMARTs also show considerable promise in innovating intervention approaches within prevention contexts.
In this study, the investigators will compress and test a variety of formats, sequences, and doses of ADAPT. The investigators will provide two 'first line' ADAPT programs and two slightly more intensive booster ADAPT programs for families who do not 'respond' to the first line intervention. Adaptive intervention strategies involve decision rules that specify how the type or intensity of an intervention should change depending on participants' response on a predetermined indicator of initial progress within an intervention. Within a SMART, a measure of initial response is used following delivery of an intervention in order to evaluate each families' need for further intervention programming. In this way, programming is tailored to meet the needs of individual families by providing additional services only to those families who are likely to benefit. This measure of initial response is referred to as a primary tailoring variable. In the proposed study, the primary tailoring variable is parental locus of control, a key variable shown in prior studies to predict change in observed parenting effectiveness, as well as change in other outcomes (PTSD symptoms, suicidality, and child adjustment).
The tested formats, sequences, and doses of ADAPT include:
- Begin with ADAPT Online. Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped-up to booster individual face-to-face ADAPT.
- Begin with ADAPT Online. Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped -up to booster group-based ADAPT.
- Begin with ADAPT condensed group (with online support). Parents exhibiting initial response receive continued access to online resources. Parents exhibiting non-response are stepped to booster group-based ADAPT.
- Begin with ADAPT condensed group (with online support). Parents exhibiting initial response continue access to online resources. Parents exhibiting non-response are stepped-up to booster group-based ADAPT.
This approach allows families who do not need intensive services to receive appropriately brief services. Those higher-need families receive more intensive services.
To address Aim 1, the investigators will compress the ADAPT group and individual curriculum, through consultation with service members, spouse, and content experts. The investigators will conduct two focus groups with parents who have returned from deployment (including spouses) and live on military installations and will assemble a Panel of 7 experts via a video conference call to inform program modifications. Each of the two parent focus group will consist of 12 families (24 individuals), one group at Fort Bragg with Special Operations (SO) participants, one group at Joint Base Lewis-McChord (JBLM) and Ft. Campbell with 12 Regular Army (RA) participants. To ensure gender sensitivity, the investigators will recruit and ask similar questions of mothers and fathers.
The investigators will ask an Expert Panel to view and advise on modifications to the current ADAPT NG/R group and individual materials. After reviewing the report of the focus group results, an Expert Panel will gather via videoconference (Month 4). Panel experts will weigh in on the results and be provided with two weeks to provide written recommendations. Expert panel and focus group feedback will inform (i) how to best compress key ADAPT skills, and (ii) address issues specific to high deployment OPTEMPO conditions. The focus group data and panel feedback will be used to finalize components for the SMART.
To address Aims 2,3,4: Among 210 SO and 315 RA families (i.e., total N=525 families) with 5-12 year-old children, the investigators will examine effects of ADAPT modalities and sequences/timing on multiple behaviors and outcomes (i.e., (i) coercive family interactions, positive parenting, couple adjustment, and co-parenting, (ii) parents PTSD symptoms, depression symptoms, substance use, (iii) child behavior and emotional problems, and positive adjustment, by conducting a 2-stage SMART, and (iv) document participation, satisfaction, and fidelity. To assess behaviors and outcomes, the investigators will administer and collect a series of assessments at 4 timepoints.
For Aims 2, 3, and 4, the investigators will use a 2-stage SMART design to examine the optimal sequence, dosage, and delivery formats of ADAPT for active duty military families living in a range of operational tempo contexts. The investigators will recruit a total of 525 families living on three installations: FT Bragg, FTs Belvoir/Myer and FT Campbell, with 210 families recruited from FTs Bragg and Campbell, and 105 from FTs Belvoir/Myer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Sequential multiple assignment randomization trial
| Arm | Type | Receives |
|---|---|---|
| Phase 1: ADAPT Workshop | Experimental | Behavioral: Phase 1: ADAPT Workshop2 - day long in-person workshops (7 hours each day). Workshops are 2 weeks apart. |
| Phase 1: ADAPT Online | Experimental | Behavioral: Phase 1: ADAPT Online3 weeks are given to complete 12 online modules using a secure website. Online modules include skill video, practice video, summary sheets, mindfulness audio and exercise video, printable handouts and motivation questionnaire. |
| Phase 2: ADAPT Group | Experimental | Behavioral: Phase 2: ADAPT Group3 - 2 hour long in-person group sessions. Group sessions are consecutive weeks. |
| Phase 2: ADAPT Individual | Experimental | Behavioral: Phase 2: ADAPT Individual3 - 1 1/2 hour in-person individual sessions. Sessions are consecutive weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- families in which one parent has returned from deployment
- families with at least one child age 5 to 12 in their custody and living with parent(s) in the home
- must agree to randomization
- must indicate willingness to interact with study materials and complete assessment batteries
Key exclusion criteria (7 listed)
- families with children younger than 5 or older than 12
- families in which at least one parent has an active psychosis
- families with an open child protection case for abuse or neglect in the family
- families in which there is a child with a serious mental health diagnosis (i.e., autism, child psychosis)
- youth who have a documented pervasive developmental disability or mental retardation
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 |
|---|---|---|
| Phase 1: ADAPT Workshop2 day workshop | Behavioural | Phase 1: ADAPT Workshop |
| Phase 1: ADAPT OnlineOnline curriculum | Behavioural | Phase 1: ADAPT Online |
| Phase 2: ADAPT Group3 in person group sessions | Behavioural | Phase 2: ADAPT Group |
| Phase 2: ADAPT Individual3 sessions in person one on one | Behavioural | Phase 2: ADAPT Individual |
Primary outcome
Change in Observed Parenting Effectiveness
Time frame: T1 (baseline), T3 (1 year) and T4 (2 years). Change is being assessed, primarily change between T1 and T3.
Family Interaction Tasks (FIT) with each parent and child
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 1 Dec 2022.
- Background: PubMed 22438190Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
- Background: PubMed 24839882Kasari C, Kaiser A, Goods K, Nietfeld J, Mathy P, Landa R, Murphy S, Almirall D. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):635-46. doi: 10.1016/j.jaac.2014.01.019. Epub 2014 Mar 12.
- Background: PubMed 17971530Thall PF, Logothetis C, Pagliaro LC, Wen S, Brown MA, Williams D, Millikan RE. Adaptive therapy for androgen-independent prostate cancer: a randomized selection trial of four regimens. J Natl Cancer Inst. 2007 Nov 7;99(21):1613-22. doi: 10.1093/jnci/djm189. Epub 2007 Oct 30.
- Background: PubMed 17056207Murphy SA, Lynch KG, Oslin D, McKay JR, TenHave T. Developing adaptive treatment strategies in substance abuse research. Drug Alcohol Depend. 2007 May;88 Suppl 2(Suppl 2):S24-30. doi: 10.1016/j.drugalcdep.2006.09.008. Epub 2006 Oct 23.
- Background: PubMed 25256135August GJ, Piehler TF, Bloomquist ML. Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency. J Clin Child Adolesc Psychol. 2016 Jul-Aug;45(4):495-509. doi: 10.1080/15374416.2014.945212. Epub 2014 Sep 25.
- Individual participant dataSharing planned: No
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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.
Abigail Gewirtz, PhD principal investigator
University of Minnesota and Arizona State University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1: ADAPT Workshop, Phase 1: ADAPT Online and Phase 2: ADAPT Group in people with Parenting, run by University of Minnesota at 4 sites 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 4 inclusion and 7 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Change in Observed Parenting Effectiveness (time frame: T1 (baseline), T3 (1 year) and T4 (2 years). Change is being assessed, primarily change between T1 and T3.). 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 NCT05509348, which also lists 5 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 1 Dec 2022.