Trial · NCT00723580
Actigraphic Analysis of Treatment Response
NCT00723580, Not applicable, Completed, Child Psychopharmacology Institute; results first posted 2010-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Actigraphic Analysis of Treatment Response. Trials, record NCT00723580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723580
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Actigraphic Analysis of Treatment Response
- NCT number
- NCT00723580
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1 participants, actual
- Lead sponsor
- Child Psychopharmacology Institute
- Conditions
- Sleep Disorders, Circadian Rhythm, Insomnia, Psychomotor Agitation
- Interventions
- risperidone
- First posted
- 2008-07-28
- Last updated
- 2015-08-18
- Results first posted
- 2010-12-14
- Limitations and caveats
This single case study has limited generalizability in that these results may not apply to others. The methods explored, however, may apply to others and Single-subject repeated measurements can provide valuable clinical and scientific data.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Actigraphic Measurement of Treatment Conditions | May 12- July 14, 2010 | The child's impulsivity and inability to sleep represented a significant symptom and risk factor. Impulsivity and sleep will be actigraphically assessed by treatment conditions. |
| Secondary | Systematic Observation Scale Item: Percentage of Impulsivity Observed | May-7-2008 to July -14-2010 | The Systematic Observation Scale utilizes single-subject repeated measurements. Symptoms and issues of interest are defined and a variety of frequency and sampling methods can be applied. The Systematic Observation Scale was designed so Primary Observers (parents, guardians, self observers or others) can make pre-treatment and subsequent observations to track, document and evaluate symptom variation over the course of an illness. The measurement utilized is the percentage of time the symptom is observed by the primary observer since the previous observation. |
| Secondary | Systematic Observation Scale: Percentage of Irritability Observed | May-7-2008 to July -14-2010 | |
| Secondary | Systematic Observation Scale: Percentage of Distractibility Observed | May-7-2008 to July -14-2010 | |
| Secondary | Systematic Observation Scale: Percentage of Hyperactivity Observed | May-7-2008 to July -14-2010 | |
| Secondary | The Personality Inventory for Children: Adjustment Scale | May-7-2008 to July -14-2010 | This scale measures general personality adjustment reflecting a dimension associated with highly adaptive to maladaptive adjustment. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. The PIC was administered prior to treatment with risperidone and repeated after 22 months of treatment. The PIC serves as both an actuarial pre-treatment diagnostic tool as well as a post-treatment repeated measurement indicating treatment and developmentally associated change. |
| Secondary | The Personality Inventory for Children: Achievement Scale | May-7-2008 to July -14-2010 | The factors that underlie this scale are academic ability, poor achievement, impulsivity, limited concentration and over or under-assertiveness with peers. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. |
| Secondary | The Personality Inventory for Children: Somatic-Physiological Scale | May-7-2008 to July -14-2010 | The factors that underlie this scale are fatigue, aches and pains, insomnia, somatic response to stress and malingering. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. |
| Secondary | The Personality Inventory for Children: Delinquency Scale | May 7, 2008-July 14,2010 | The factors that underlie this scale are poor frustration tolerance, irritability, sadness, lack of interest, hostility,limited social participation and resistance to authority. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function. |
| Secondary | The Personality Inventory for Children: Withdrawal Scale | May-7-2008 to July -14-2010 | The factors that underlie this scale are physical isolation, Shyness, isolation from peers, emotional distance and isolated intellectual interests. The Personality Inventory for Children (PIC) is an age and gender referenced objective multidimensional measurement of affect, behavior, ability and family function |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Actigraphic Measurement of Treatment Conditions | May 12- July 14, 2010 | Single subject repeated Actigraphic(at thirty second intervals), observational (every two months) and psychometric (baseline and at 23 months) measurements of a child anticipating pharmacological treatment. Actigraphic measurements (three 21 day periods) over five treatment conditions that included a non-medication baseline and spanned 23 months. | activity | MEAN |
| SECONDARY | Systematic Observation Scale Item: Percentage of Impulsivity Observed | May-7-2008 to July -14-2010 | |||
| SECONDARY | Systematic Observation Scale: Percentage of Irritability Observed | May-7-2008 to July -14-2010 | |||
| SECONDARY | Systematic Observation Scale: Percentage of Distractibility Observed | May-7-2008 to July -14-2010 | |||
| SECONDARY | Systematic Observation Scale: Percentage of Hyperactivity Observed | May-7-2008 to July -14-2010 | |||
| SECONDARY | The Personality Inventory for Children: Adjustment Scale | May-7-2008 to July -14-2010 | |||
| SECONDARY | The Personality Inventory for Children: Achievement Scale | May-7-2008 to July -14-2010 | |||
| SECONDARY | The Personality Inventory for Children: Somatic-Physiological Scale | May-7-2008 to July -14-2010 | |||
| SECONDARY | The Personality Inventory for Children: Delinquency Scale | May 7, 2008-July 14,2010 | |||
| SECONDARY | The Personality Inventory for Children: Withdrawal Scale | May-7-2008 to July -14-2010 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Actigraphic Measurement of Treatment Conditions | Actigraphic (Activity Count) Measurement of Sleep and Activity | Baseline No Medication Midnight to 1:00 AM | 55.02 | Standard Deviation 206.432 | activity |
| Actigraphic Measurement of Treatment Conditions | Actigraphic (Activity Count) Measurement of Sleep and Activity | risperidone .5 mg t.i.d. Midnight to 1:00 AM | 9.94 | Standard Deviation 51.651 | activity |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Actigraphic (Activity Count) Measurement of Sleep and Activity | 1 | |
| Overall Study | Baseline Measurements | Actigraphic (Activity Count) Measurement of Sleep and Activity | 1 | |
| Overall Study | COMPLETED | Actigraphic (Activity Count) Measurement of Sleep and Activity | 1 | |
| Overall Study | NOT COMPLETED | Actigraphic (Activity Count) Measurement of Sleep and Activity | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Actigraphic (Activity Count) Measurement of Sleep and Activity | ||
| Total, other adverse events | Actigraphic (Activity Count) Measurement of Sleep and Activity | 0 | 1 |
| Total, serious adverse events | Actigraphic (Activity Count) Measurement of Sleep and Activity | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00723580
GET https://conductscience.org/api/trials/v1/NCT00723580/registered