Psychosocial InterventionMCB-ADHDNCT05674968
Managing Challenging Behaviors-ADHD
A study testing Managing Challenging Behaviors in ADHD; Psychosocial program in people with Psychosocial Intervention, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test whether short, time-limited parent education programs designed to help children diagnosed with ADHD and disruptive behaviors can be helpful to families that may not be able to participate in "traditional" forms of mental health care. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Intervention
- What is being tested?
- Managing Challenging Behaviors in ADHD; Psychosocial program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 1 Jun 2024
- 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 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between ages 3-8 receiving services at the developmental pediatrics clinic at DH Lebanon referred by their physician for help with disruptive behaviors.
- A diagnosis ADHD, ODD, Adjustment Disorder with Conduct, or Disruptive Behavior Disorder documented in the chart.
- Family participating is capable of receiving in-person or telehealth care and treatment materials in English
Who cannot join
- Primary concern that would indicate that behavioral parent training would not be the treatment of choice at the time of referral, including Autism Spectrum Disorder, previously untreated Post Traumatic Stress Disorder, OCD, or Reactive Attachment Disorder. The study clinician may also use clinical judgment that the intervention is inappropriate for a particular child's needs at any point during intervention.
- Currently receiving outpatient therapy at the time of referral. The study will not exclude children on psychotropic medications, but will document medication status and changes to medication throughout treatment.
- Severe history of physical or mental impairment (e.g., intellectual disability, global developmental delay). Child must be capable of verbal communication with a parent.
- Children who are in foster care or are currently wards of the state.
- Primary caregivers under 18 years of age.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: A Pilot Feasibility Randomized Control Trial of the Managing Challenging Behaviors in ADHD
The purpose of this study is to test whether short, time-limited parent education programs designed to help children diagnosed with ADHD and disruptive behaviors can be helpful to families that may not be able to participate in "traditional" forms of mental health care. In short, the researchers want to know if a new program is acceptable and helpful for parents or caregivers looking for ways to help their child with problem behaviors related to ADHD. The researchers hope to enroll 60 families in the study. Half will be randomly assigned to participate in a 7-session therapy program and the other half will be asked to wait 24 weeks before being offered the treatment. Parents in the study will fill out questionnaires at week 1, week 14, and week 24.
The researchers' goal is to answer 2 specific questions. 1) Is this protocol acceptable to families and do they choose to participate and 2) Are the researchers able to accurately measure our outcomes of interest, specifically, changes in children's behavior problems, changes in parenting practices, and parents' perceptions of mental health care.
This study is focused on whether the intervention and study methods are acceptable. The researchers will compare the two groups to see if there are differences, but it would require a larger group of children and parents before the researchers can determine whether these differences are meaningful .
- Conditions
- Psychosocial Intervention
- Being tested
- Managing Challenging Behaviors in ADHD; Psychosocial program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Challenging Behaviors in ADHD; Psychosocial programBehavioural
MCB-ADHD is a brief Behavioral Parent Training (BPT) program delivered to caregivers and children together. THe researchers have specially designed this program to be flexible so that it can be delivered over telehealth and/or in-person. All sessions are guided by web-based tool to provide parent support materials and direct the work to be completed in session. MCB-ADHD combines brief BPT skills modules adapted from an established evidence-based BPT called Helping the Noncompliant Child (HNC; McMahon \& Forehand, 2003) with high quality psychoeducation and advocacy training that were developed by the investigators specifically for use in this project. Families receive 4 sessions adapted from HNC focused on behavior management and 2 sessions focused on education and empowerment.
| Study group | Role | What they receive |
|---|---|---|
| Managing Challenging Behaviors in ADHD | Experimental | This is a 7-session behavioral parent training delivered to children ages 3-7 referred to the study after an initial ADHD diagnosis or when challenging behaviors are identified by their medical provider. Receives: Behavioral: Managing Challenging Behaviors in ADHD; Psychosocial program |
| Wait List | No intervention | Families assigned to the wait list will complete measures at baseline, 14 weeks, and 24 weeks. After 24 weeks they will be offered the experimental treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD-5
This is a commonly used scale of inattention and hyperactivity with established norms by age group. The ADHD-5 has two sub-scales, Inattention and Hyperactivity, both comprised of 9 symptom-specific items that parents rate on a 4 point scale (0 = rarely to 4 = Very often) with higher numbers meaning more severe ADHD symptoms. Both scales also contain 6 items related to impairment in key areas of children's lives (exp: performance academically in school). Each impairment item is rated on a 4-point scale (0 = No Problem to 3 = Severe Problem) with higher numbers indicating greater impairment.
Measured: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
Change in Eyberg Child Behavior Inventory
This is a commonly used scale to assess both the frequency of children's disruptive behaviors and the extent to which the parent finds the behaviors problematic. This measure is commonly used in the target age group to assess changes in symptoms during treatment. The Eyberg Child Behavior Inventory questionnaire is measured on two subscales for a series of phrases that describe a children's behavior. The first subscale is for indicating the frequency of the behavior using a scale of 1= never to 7 = Always; the second subscale indicates yes = 1 or no = 0 for whether the behavior is currently a problem for them. Reponses are totaled with a higher score indicating greater severity of child's behavior.
Measured: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
Change in Impairment Rating Scale
This measure assesses the degree to which ADHD symptoms impair functioning. This is an analog scale that asks parents to go through each area of functioning in their child's life (social, academic, etc.) provide a short narrative about the problem their child faces and rate their level of impairment by marking a point on a line that can be divided into 100 segments. At one end of the spectrum is the anchor, "No Problem. Definitely does not need treatment or special services" and at the other end is the anchor "Extreme Problem. Definitely needs treatment or special services". Each item gets a score of 0-100 with higher scores indicating greater impairment.
Measured: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
Treatment Acceptability as evidenced by The Treatment Evaluation Inventory-Short Form
The Treatment Evaluation Inventory (TEI-SF) measure of treatment acceptability was specifically developed to evaluate parent trainings. It is a well-established quantitative measure of acceptance with an established cut-off score for 'moderate' acceptability. The TEI-SF is a single factor 9-item measure. Participants rate items on a 5-point scale 1 = Strongly Disagree to 5 = Strongly agree with one item reverse coded. Higher scores on the measure indicate higher treatment acceptability and a total score over 27 indicates moderate acceptability.
Measured: Measured only at 14 weeks after baseline in the treatment group.
Treatment acceptability as evidenced by Parent Consumer Satisfaction Questionnaire
This measure of treatment acceptability was specifically developed to evaluate caregiver's perceptions of specific aspects of our parent training program. This measure assesses the 1) difficulty and 2) usefulness of each component of treatment. For each session activity (e.g., practice of skills with interventionist), parents rated if they found the activity useful and whether they found the activity difficult on a 7-point scale (1 = "Extremely Difficult/Extremely not useful" to 7 "Extremely Easy/Extremely Useful"). Parents used the same scale to rate each of the parenting skills they were taught during the program (e.g., praise, time-out). For this measure, higher numbers indicate that a skill was perceived positively (as useful and easy to implement) and lower numbers indicate difficulty and lower usefulness.
Measured: Measured only at 14 weeks after baseline in the treatment group.
Changes in Clinician Global Impairment
This is a two item impairment scale used by the clinician to rate the impairment of the child before and after treatment. The two items are Severity of Illness and Global Improvement. Items are rated on a 7-point scale (1 = normal not at all/very much improved to 7 = Among the most extremely ill patients/very much worse). For this scale lower scores indicate better functioning and greater improvement.
Measured: Measured at baseline and 14 weeks after baseline. Treatment group only.
Secondary outcomes (3)
Changes in the Barriers to Children's Mental Health Survey
We modified this measure from its original version to include a few additional items related to barriers to care. The original measure was developed to assess parental attitudes and beliefs about both the appropriateness of mental health care and the degree to which barriers including cost, travel, and other parent responsibilities might deter or facilitate the family's ability to participate in mental health treatment. The measure is divided into two parts: tangible barriers to care (e.g., missed time from work) and intangible barriers (being embarrassed if friends or family learned they were seeking help). There are 12 items on each sub-scale. Each item is rated on a 6-point scale with 1= "not a problem/strongly disagree" to 6 "a major problem/strongly agree". Several items are reverse coded and a single score is created for each domain. Higher scores on the measure indicate experiencing more severe barriers to care.
Measured: Measured at baseline and 14 weeks after baseline.
Changes in the Parenting Scale (PS; Rhodes & Leary, 2007).
The parenting scale is a well validated and frequently used measure that assesses parents on three dimensions of negative-positive parenting 1) laxness, 2) verbosity, and 3) over reactivity. Each of the 30 items is rated on a 7-point scale. Each item provides two unique anchors at the ends of the scale that represent extremes of a parenting style. For example, on the laxness scale an items states "When my child misbehaves I..." The first anchor is "do something right away" and the anchor on the other end of the spectrum is "I do something later". Each item loads on one of the three factors with higher scores indicating more negative parenting styles.
Measured: Measured at baseline and 14 weeks after baseline.
Changes in Family Empowerment Scale
The FES is commonly used with parents of children with many types of medical and psychiatric concerns and is used to assess how efficacious caregivers feel in their ability to help their child manage and concern and advocate for their child to receive appropriate care from others (e.g., doctors and school professionals). The scale has three factors related to empowerment: Family, Service Systems, and Community/Political. Each item is rated on 5-point scale (1= not true at all to 5 = very true). Higher scores indicate a greater sense of caregiver empowerment.
Measured: Measured at baseline and 14 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start10 Oct 2022
- Primary completion1 Jul 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial InterventionStudies 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
- Model description
- 60 families will be enrolled in the study. The researchers will use block randomization to assign half to the treatment group and half to a wait-list control group. Participants will be blocked by gender and condition.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James T. Craig, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674968
- Sponsor's protocol ID
- STUDY02001611
- Acronym
- MCB-ADHD
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Randomized Control Trial of the Managing Challenging Behaviors in ADHD
- ClinicalTrials.gov ID
- NCT05674968
- Acronym / sponsor ID
- MCB-ADHD / STUDY02001611
- Conditions
- Psychosocial Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Jan 2023 (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 purpose of this study is to test whether short, time-limited parent education programs designed to help children diagnosed with ADHD and disruptive behaviors can be helpful to families that may not be able to participate in "traditional" forms of mental health care. In short, the researchers want to know if a new program is acceptable and helpful for parents or caregivers looking for ways to help their child with problem behaviors related to ADHD. The researchers hope to enroll 60 families in the study. Half will be randomly assigned to participate in a 7-session therapy program and the other half will be asked to wait 24 weeks before being offered the treatment. Parents in the study will fill out questionnaires at week 1, week 14, and week 24.
The researchers' goal is to answer 2 specific questions. 1) Is this protocol acceptable to families and do they choose to participate and 2) Are the researchers able to accurately measure our outcomes of interest, specifically, changes in children's behavior problems, changes in parenting practices, and parents' perceptions of mental health care.
This study is focused on whether the intervention and study methods are acceptable. The researchers will compare the two groups to see if there are differences, but it would require a larger group of children and parents before the researchers can determine whether these differences are meaningful .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 60 families will be enrolled in the study. The researchers will use block randomization to assign half to the treatment group and half to a wait-list control group. Participants will be blocked by gender and condition.
| Arm | Type | Receives |
|---|---|---|
| Managing Challenging Behaviors in ADHD | Experimental | Behavioral: Managing Challenging Behaviors in ADHD; Psychosocial programThis is a 7-session behavioral parent training delivered to children ages 3-7 referred to the study after an initial ADHD diagnosis or when challenging behaviors are identified by their medical provider. |
| Wait List | No intervention | –Families assigned to the wait list will complete measures at baseline, 14 weeks, and 24 weeks. After 24 weeks they will be offered the experimental treatment. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between ages 3-8 receiving services at the developmental pediatrics clinic at DH Lebanon referred by their physician for help with disruptive behaviors.
- A diagnosis ADHD, ODD, Adjustment Disorder with Conduct, or Disruptive Behavior Disorder documented in the chart.
- Family participating is capable of receiving in-person or telehealth care and treatment materials in English
Key exclusion criteria (5 listed)
- Primary concern that would indicate that behavioral parent training would not be the treatment of choice at the time of referral, including Autism Spectrum Disorder, previously untreated Post Traumatic Stress Disorder, OCD, or Reactive Attachment Disorder. The study clinician may also use clinical judgment that the intervention is inappropriate for a particular child's needs at any point during intervention.
- Currently receiving outpatient therapy at the time of referral. The study will not exclude children on psychotropic medications, but will document medication status and changes to medication throughout treatment.
- Severe history of physical or mental impairment (e.g., intellectual disability, global developmental delay). Child must be capable of verbal communication with a parent.
- Children who are in foster care or are currently wards of the state.
- Primary caregivers under 18 years of age.
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 |
|---|---|---|
| Managing Challenging Behaviors in ADHD; Psychosocial programMCB-ADHD is a brief Behavioral Parent Training (BPT) program delivered to caregivers and children together. THe researchers have specially designed this program to be flexible so that it can be delivered over telehealth and/or in-person. All sessions are guided by web-based tool to provide parent support materials and direct the work to be completed in session. MCB-ADHD combines brief BPT skills modules adapted from an established evidence-based BPT called Helping the Noncompliant Child (HNC; McMahon \& Forehand, 2003) with high quality psychoeducation and advocacy training that were developed by the investigators specifically for use in this project. Families receive 4 sessions adapted from HNC focused on behavior management and 2 sessions focused on education and empowerment. | Behavioural | Managing Challenging Behaviors in ADHD |
Primary outcome
Change in ADHD-5
Time frame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
This is a commonly used scale of inattention and hyperactivity with established norms by age group. The ADHD-5 has two sub-scales, Inattention and Hyperactivity, both comprised of 9 symptom-specific items that parents rate on a 4 point scale (0 = rarely to 4 = Very often) with higher numbers meaning more severe ADHD symptoms. Both scales also contain 6 items related to impairment in key areas of children's lives (exp: performance academically in school). Each impairment item is rated on a 4-point scale (0 = No Problem to 3 = Severe Problem) with higher numbers indicating greater impairment.
Change in Eyberg Child Behavior Inventory
Time frame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
This is a commonly used scale to assess both the frequency of children's disruptive behaviors and the extent to which the parent finds the behaviors problematic. This measure is commonly used in the target age group to assess changes in symptoms during treatment. The Eyberg Child Behavior Inventory questionnaire is measured on two subscales for a series of phrases that describe a children's behavior. The first subscale is for indicating the frequency of the behavior using a scale of 1= never to 7 = Always; the second subscale indicates yes = 1 or no = 0 for whether the behavior is currently a problem for them. Reponses are totaled with a higher score indicating greater severity of child's behavior.
Change in Impairment Rating Scale
Time frame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.
This measure assesses the degree to which ADHD symptoms impair functioning. This is an analog scale that asks parents to go through each area of functioning in their child's life (social, academic, etc.) provide a short narrative about the problem their child faces and rate their level of impairment by marking a point on a line that can be divided into 100 segments. At one end of the spectrum is the anchor, "No Problem. Definitely does not need treatment or special services" and at the other end is the anchor "Extreme Problem. Definitely needs treatment or special services". Each item gets a score of 0-100 with higher scores indicating greater impairment.
Treatment Acceptability as evidenced by The Treatment Evaluation Inventory-Short Form
Time frame: Measured only at 14 weeks after baseline in the treatment group.
The Treatment Evaluation Inventory (TEI-SF) measure of treatment acceptability was specifically developed to evaluate parent trainings. It is a well-established quantitative measure of acceptance with an established cut-off score for 'moderate' acceptability. The TEI-SF is a single factor 9-item measure. Participants rate items on a 5-point scale 1 = Strongly Disagree to 5 = Strongly agree with one item reverse coded. Higher scores on the measure indicate higher treatment acceptability and a total score over 27 indicates moderate acceptability.
Treatment acceptability as evidenced by Parent Consumer Satisfaction Questionnaire
Time frame: Measured only at 14 weeks after baseline in the treatment group.
This measure of treatment acceptability was specifically developed to evaluate caregiver's perceptions of specific aspects of our parent training program. This measure assesses the 1) difficulty and 2) usefulness of each component of treatment. For each session activity (e.g., practice of skills with interventionist), parents rated if they found the activity useful and whether they found the activity difficult on a 7-point scale (1 = "Extremely Difficult/Extremely not useful" to 7 "Extremely Easy/Extremely Useful"). Parents used the same scale to rate each of the parenting skills they were taught during the program (e.g., praise, time-out). For this measure, higher numbers indicate that a skill was perceived positively (as useful and easy to implement) and lower numbers indicate difficulty and lower usefulness.
Changes in Clinician Global Impairment
Time frame: Measured at baseline and 14 weeks after baseline. Treatment group only.
This is a two item impairment scale used by the clinician to rate the impairment of the child before and after treatment. The two items are Severity of Illness and Global Improvement. Items are rated on a 7-point scale (1 = normal not at all/very much improved to 7 = Among the most extremely ill patients/very much worse). For this scale lower scores indicate better functioning and greater improvement.
3 secondary outcomes
Changes in the Barriers to Children's Mental Health Survey
Time frame: Measured at baseline and 14 weeks after baseline.
Changes in the Parenting Scale (PS; Rhodes & Leary, 2007).
Time frame: Measured at baseline and 14 weeks after baseline.
Changes in Family Empowerment Scale
Time frame: Measured at baseline and 14 weeks after baseline.
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 24 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Challenging Behaviors in ADHD; Psychosocial program in people with Psychosocial Intervention, run by Dartmouth-Hitchcock Medical Center 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 24 Jun 2024. 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?
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 ADHD-5 (time frame: Measured at baseline, 14 weeks post baseline, and 24 weeks post baseline.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.