Trial Outcomes & Findings for Shifting Perspectives: Enhancing Outcomes in Anorexia Nervosa With CRT (NCT NCT03928028)
NCT ID: NCT03928028
Last Updated: 2023-01-20
Results Overview
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Trail Making Test assesses flexibility in thinking. We use Condition 4 (Number-Letter Switching) to assess flexibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
177 participants
Primary outcome timeframe
6 months of treatment
Results posted on
2023-01-20
Participant Flow
Unit of analysis: Families
Participant milestones
| Measure |
Family Based Treatment (FBT)
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Overall Study
STARTED
|
63 21
|
57 19
|
57 19
|
|
Overall Study
Mother
|
21 21
|
19 19
|
19 19
|
|
Overall Study
Father
|
21 21
|
19 19
|
19 19
|
|
Overall Study
Adolescent
|
21 21
|
19 19
|
19 19
|
|
Overall Study
COMPLETED
|
42 14
|
48 16
|
51 17
|
|
Overall Study
NOT COMPLETED
|
21 7
|
9 3
|
6 2
|
Reasons for withdrawal
| Measure |
Family Based Treatment (FBT)
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
9
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
3
|
3
|
Baseline Characteristics
Adolescents, mothers, and fathers are reported separately.
Baseline characteristics by cohort
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=63 Participants
|
19 Participants
n=57 Participants
|
19 Participants
n=57 Participants
|
59 Participants
n=177 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=63 Participants
|
37 Participants
n=57 Participants
|
38 Participants
n=57 Participants
|
117 Participants
n=177 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=63 Participants
|
1 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=177 Participants
|
|
Age, Continuous
Adolescents
|
15.51 years
STANDARD_DEVIATION 1.81 • n=21 Participants • Adolescents, mothers, and fathers are reported separately.
|
15.21 years
STANDARD_DEVIATION 1.53 • n=19 Participants • Adolescents, mothers, and fathers are reported separately.
|
15.25 years
STANDARD_DEVIATION 1.61 • n=19 Participants • Adolescents, mothers, and fathers are reported separately.
|
15.335 years
STANDARD_DEVIATION 1.641 • n=59 Participants • Adolescents, mothers, and fathers are reported separately.
|
|
Age, Continuous
Mothers
|
48.18 years
STANDARD_DEVIATION 3.61 • n=21 Participants • Adolescents, mothers, and fathers are reported separately.
|
47.46 years
STANDARD_DEVIATION 6.25 • n=19 Participants • Adolescents, mothers, and fathers are reported separately.
|
47.30 years
STANDARD_DEVIATION 2.997 • n=19 Participants • Adolescents, mothers, and fathers are reported separately.
|
47.66 years
STANDARD_DEVIATION 4.42 • n=59 Participants • Adolescents, mothers, and fathers are reported separately.
|
|
Age, Continuous
Fathers
|
50.65 years
STANDARD_DEVIATION 5.98 • n=21 Participants • Adolescents, mothers, and fathers are reported separately.
|
49.93 years
STANDARD_DEVIATION 6.82 • n=19 Participants • Adolescents, mothers, and fathers are reported separately.
|
48.97 years
STANDARD_DEVIATION 4.82 • n=19 Participants • Adolescents, mothers, and fathers are reported separately.
|
49.88 years
STANDARD_DEVIATION 5.87 • n=59 Participants • Adolescents, mothers, and fathers are reported separately.
|
|
Sex: Female, Male
Female
|
39 Participants
n=63 Participants
|
36 Participants
n=57 Participants
|
35 Participants
n=57 Participants
|
110 Participants
n=177 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=63 Participants
|
21 Participants
n=57 Participants
|
22 Participants
n=57 Participants
|
67 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=63 Participants
|
1 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
4 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=63 Participants
|
54 Participants
n=57 Participants
|
55 Participants
n=57 Participants
|
167 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=63 Participants
|
2 Participants
n=57 Participants
|
2 Participants
n=57 Participants
|
6 Participants
n=177 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=63 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=63 Participants
|
6 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
6 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=63 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=63 Participants
|
0 Participants
n=57 Participants
|
3 Participants
n=57 Participants
|
3 Participants
n=177 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=63 Participants
|
49 Participants
n=57 Participants
|
53 Participants
n=57 Participants
|
160 Participants
n=177 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=63 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=63 Participants
|
2 Participants
n=57 Participants
|
1 Participants
n=57 Participants
|
7 Participants
n=177 Participants
|
|
Region of Enrollment
United States
|
63 Participants
n=63 Participants
|
57 Participants
n=57 Participants
|
57 Participants
n=57 Participants
|
177 Participants
n=177 Participants
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Trail Making Test assesses flexibility in thinking. We use Condition 4 (Number-Letter Switching) to assess flexibility.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Mother - T3
|
11.14 score on a scale
Standard Deviation 2.742
|
11.86 score on a scale
Standard Deviation 2.107
|
12.00 score on a scale
Standard Deviation 1.663
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Adolescent - T3
|
9.50 score on a scale
Standard Deviation 3.555
|
11.71 score on a scale
Standard Deviation 1.773
|
10.83 score on a scale
Standard Deviation 1.115
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Mother- T1
|
11.89 score on a scale
Standard Deviation .875
|
10.94 score on a scale
Standard Deviation 2.331
|
11.47 score on a scale
Standard Deviation 1.663
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Mother - T4
|
12.18 score on a scale
Standard Deviation .874
|
12.70 score on a scale
Standard Deviation .675
|
12.27 score on a scale
Standard Deviation 1.191
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
1Mother - T5
|
12.75 score on a scale
Standard Deviation 1.165
|
13.11 score on a scale
Standard Deviation .782
|
13.25 score on a scale
Standard Deviation 1.708
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Father - T1
|
11.14 score on a scale
Standard Deviation 2.265
|
11.06 score on a scale
Standard Deviation 1.819
|
11.35 score on a scale
Standard Deviation 2.060
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Father - T3
|
11.92 score on a scale
Standard Deviation 1.382
|
12.57 score on a scale
Standard Deviation 1.342
|
12.23 score on a scale
Standard Deviation 1.092
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Father - T4
|
11.82 score on a scale
Standard Deviation 2.136
|
13.10 score on a scale
Standard Deviation 1.101
|
12.09 score on a scale
Standard Deviation 1.640
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Father - T5
|
12.14 score on a scale
Standard Deviation 1.069
|
12.80 score on a scale
Standard Deviation .919
|
13.00 score on a scale
Standard Deviation 1.549
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Adolescent - T1
|
9.47 score on a scale
Standard Deviation 3.151
|
10.59 score on a scale
Standard Deviation 2.033
|
10.94 score on a scale
Standard Deviation 1.144
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Adolescent - T4
|
11.00 score on a scale
Standard Deviation 2.404
|
12.50 score on a scale
Standard Deviation .850
|
11.64 score on a scale
Standard Deviation 1.567
|
|
Change in Cognitive Flexibility - Condition 4 Trail Making Test of DKEFS
Adolescent - T5
|
12.50 score on a scale
Standard Deviation 1.414
|
12.33 score on a scale
Standard Deviation 1.225
|
11.50 score on a scale
Standard Deviation 1.643
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). Inhibition refers to the ability to inhibit a well learned or salient task in order to do something different; thus, it is related to flexibility. The D-KEFS Color-Word Interference Test (Condition 3: Inhibition) to assess ability to inhibit automatic responses.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Mother - T5
|
13.67 score on a scale
Standard Deviation 1.923
|
12.93 score on a scale
Standard Deviation 1.668
|
13.33 score on a scale
Standard Deviation 1.718
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Mother -T1
|
11.95 score on a scale
Standard Deviation 2.291
|
11.84 score on a scale
Standard Deviation 1.608
|
12.21 score on a scale
Standard Deviation 2.175
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Mother - T3
|
12.72 score on a scale
Standard Deviation 1.565
|
12.06 score on a scale
Standard Deviation 1.237
|
12.94 score on a scale
Standard Deviation 2.014
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Mother - T4
|
13.06 score on a scale
Standard Deviation 1.436
|
12.25 score on a scale
Standard Deviation 1.528
|
13.12 score on a scale
Standard Deviation 1.996
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Father - T1
|
11.14 score on a scale
Standard Deviation 2.689
|
12.11 score on a scale
Standard Deviation 1.941
|
11.63 score on a scale
Standard Deviation 2.52
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Father - T3
|
11.94 score on a scale
Standard Deviation 1.798
|
13.06 score on a scale
Standard Deviation 1.436
|
12.50 score on a scale
Standard Deviation 2.176
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Father - T4
|
12.43 score on a scale
Standard Deviation 1.742
|
12.75 score on a scale
Standard Deviation 2.840
|
13.00 score on a scale
Standard Deviation 1.581
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Father - T5
|
12.55 score on a scale
Standard Deviation 1.753
|
13.67 score on a scale
Standard Deviation 1.291
|
12.80 score on a scale
Standard Deviation 1.740
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Adolescent-T1
|
10.76 score on a scale
Standard Deviation 2.300
|
11.95 score on a scale
Standard Deviation 2.272
|
11.11 score on a scale
Standard Deviation 3.008
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Adolescent - T3
|
11.47 score on a scale
Standard Deviation 2.348
|
12.94 score on a scale
Standard Deviation 1.482
|
1.35 score on a scale
Standard Deviation 2.548
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Adolescent - T4
|
12.67 score on a scale
Standard Deviation 1.676
|
13.31 score on a scale
Standard Deviation 1.448
|
12.76 score on a scale
Standard Deviation 2.412
|
|
Change in Inhibition - Condition 3 of Color-Word Interference, DKEFS
Adolescent - T5
|
12.83 score on a scale
Standard Deviation 1.642
|
13.14 score on a scale
Standard Deviation 1.610
|
13.00 score on a scale
Standard Deviation 2.204
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Color Word Interference (Condition 4: Inhibition/Switching) assess the ability to switch between alternating rules (a component of set shifting).
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Mother - T1
|
11.71 score on a scale
Standard Deviation 1.101
|
11.05 score on a scale
Standard Deviation 1.615
|
11.95 score on a scale
Standard Deviation 2.041
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Mother - T3
|
12.78 score on a scale
Standard Deviation 1.215
|
12.50 score on a scale
Standard Deviation 1.633
|
12.78 score on a scale
Standard Deviation 1.700
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Mother - T4
|
12.75 score on a scale
Standard Deviation 1.844
|
12.63 score on a scale
Standard Deviation 1.586
|
13.35 score on a scale
Standard Deviation 1.801
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Mother - T5
|
13.83 score on a scale
Standard Deviation 1.467
|
13.13 score on a scale
Standard Deviation 1.356
|
13.40 score on a scale
Standard Deviation 1.549
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Father - T1
|
11.67 score on a scale
Standard Deviation 2.106
|
12.05 score on a scale
Standard Deviation 1.433
|
11.37 score on a scale
Standard Deviation 2.929
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Father - T3
|
12.56 score on a scale
Standard Deviation 1.504
|
13.13 score on a scale
Standard Deviation 1.088
|
12.56 score on a scale
Standard Deviation 1.790
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Father - T4
|
12.86 score on a scale
Standard Deviation 2.070
|
13.19 score on a scale
Standard Deviation 1.515
|
12.94 score on a scale
Standard Deviation 1.391
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Father - T5
|
13.09 score on a scale
Standard Deviation 1.446
|
13.73 score on a scale
Standard Deviation 1.033
|
13.00 score on a scale
Standard Deviation 1.414
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Adolescent - T1
|
11.52 score on a scale
Standard Deviation 2.994
|
11.63 score on a scale
Standard Deviation 2.385
|
11.61 score on a scale
Standard Deviation 1.914
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Adolescent - T3
|
12.59 score on a scale
Standard Deviation 2.763
|
13.00 score on a scale
Standard Deviation 1.751
|
12.35 score on a scale
Standard Deviation 2.262
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Adolescent - T4
|
13.60 score on a scale
Standard Deviation 1.957
|
13.50 score on a scale
Standard Deviation 2.160
|
13.29 score on a scale
Standard Deviation 2.114
|
|
Change in Cognitive Flexibility - Condition 4 of Color Word Interference of DKEFS
Adolescent - T5
|
14.17 score on a scale
Standard Deviation 1.030
|
13.71 score on a scale
Standard Deviation 2.016
|
13.27 score on a scale
Standard Deviation 2.154
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. The Switching Correct score is used to assess flexibility.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T1
|
12.10 score on a scale
Standard Deviation 3.478
|
11.95 score on a scale
Standard Deviation 2.718
|
11.74 score on a scale
Standard Deviation 4.483
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T3
|
12.47 score on a scale
Standard Deviation 3.717
|
12.44 score on a scale
Standard Deviation 3.444
|
11.18 score on a scale
Standard Deviation 3.695
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T4
|
13.00 score on a scale
Standard Deviation 4.195
|
12.44 score on a scale
Standard Deviation 3.464
|
13.29 score on a scale
Standard Deviation 4.089
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T5
|
12.42 score on a scale
Standard Deviation 3.288
|
13.53 score on a scale
Standard Deviation 2.446
|
13.47 score on a scale
Standard Deviation 2.949
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T1
|
11.81 score on a scale
Standard Deviation 3.628
|
10.68 score on a scale
Standard Deviation 3.973
|
10.63 score on a scale
Standard Deviation 3.218
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T3
|
11.68 score on a scale
Standard Deviation 3.528
|
11.50 score on a scale
Standard Deviation 3.759
|
11.33 score on a scale
Standard Deviation 4.102
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T4
|
12.71 score on a scale
Standard Deviation 4.286
|
11.88 score on a scale
Standard Deviation 3.757
|
12.00 score on a scale
Standard Deviation 3.386
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T5
|
12.45 score on a scale
Standard Deviation 2.911
|
11.43 score on a scale
Standard Deviation 3.694
|
11.73 score on a scale
Standard Deviation 4.399
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T1
|
11.55 score on a scale
Standard Deviation 3.677
|
12.42 score on a scale
Standard Deviation 3.006
|
11.50 score on a scale
Standard Deviation 1.917
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T3
|
10.89 score on a scale
Standard Deviation 3.411
|
12.31 score on a scale
Standard Deviation 3.135
|
9.88 score on a scale
Standard Deviation 3.967
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T4
|
11.80 score on a scale
Standard Deviation 3.707
|
12.47 score on a scale
Standard Deviation 2.722
|
9.41 score on a scale
Standard Deviation 4.459
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T5
|
11.92 score on a scale
Standard Deviation 4.033
|
11.36 score on a scale
Standard Deviation 2.590
|
11.80 score on a scale
Standard Deviation 2.513
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The D-KEFS Verbal Fluency assesses the ability to shift between concepts. Switching Accuracy assesses the number of times an accurate switch between categories occurs.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T1
|
11.90 score on a scale
Standard Deviation 3.567
|
11.68 score on a scale
Standard Deviation 3.637
|
11.95 score on a scale
Standard Deviation 4.183
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T3
|
11.63 score on a scale
Standard Deviation 2.929
|
11.56 score on a scale
Standard Deviation 1.590
|
11.24 score on a scale
Standard Deviation 2.166
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T4
|
14.06 score on a scale
Standard Deviation 3.043
|
12.63 score on a scale
Standard Deviation 3.284
|
13.65 score on a scale
Standard Deviation 3.968
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Mother - T5
|
11.58 score on a scale
Standard Deviation 1.975
|
12.07 score on a scale
Standard Deviation 1.335
|
12.13 score on a scale
Standard Deviation 1.356
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T1
|
11.81 score on a scale
Standard Deviation 3.628
|
10.37 score on a scale
Standard Deviation 3.890
|
11.50 score on a scale
Standard Deviation 2.854
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T3
|
11.68 score on a scale
Standard Deviation 3.528
|
11.13 score on a scale
Standard Deviation 2.705
|
11.56 score on a scale
Standard Deviation 2.549
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T4
|
12.71 score on a scale
Standard Deviation 4.286
|
12.06 score on a scale
Standard Deviation 3.958
|
12.00 score on a scale
Standard Deviation 3.386
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Father - T5
|
12.45 score on a scale
Standard Deviation 2.911
|
11.21 score on a scale
Standard Deviation 2.155
|
11.53 score on a scale
Standard Deviation 1.846
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T1
|
11.45 score on a scale
Standard Deviation 3.634
|
11.95 score on a scale
Standard Deviation 2.549
|
11.28 score on a scale
Standard Deviation 2.321
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T3
|
11.56 score on a scale
Standard Deviation 1.617
|
12.19 score on a scale
Standard Deviation 1.559
|
10.88 score on a scale
Standard Deviation 2.233
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T4
|
12.20 score on a scale
Standard Deviation 3.299
|
12.13 score on a scale
Standard Deviation 2.90
|
10.18 score on a scale
Standard Deviation 4.261
|
|
Change in Cognitive Flexibility - Verbal Fluency Switching of DKEFS
Adolescent - T5
|
12.00 score on a scale
Standard Deviation 1.758
|
12.00 score on a scale
Standard Deviation 1.414
|
11.93 score on a scale
Standard Deviation 1.486
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Delis Kaplan Executive Functioning System (D-KEFS) is a standardized assessment of executive functioning normed for ages 8-89 years of age. Raw scores are transformed to scaled scores: the mean is 10 with a standard deviation of 3. Higher scores indicate better performance on the test. Specific sub-tests were chosen to assess inhibitory control and cognitive flexibility. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants. The D-KEFS was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The Sorting Test assesses flexibility in thinking and problem solving.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Father - T5
|
14.00 score on a scale
Standard Deviation 1.789
|
14.60 score on a scale
Standard Deviation 2.366
|
15.00 score on a scale
Standard Deviation 1.414
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Mother - T1
|
11.94 score on a scale
Standard Deviation 3.334
|
11.47 score on a scale
Standard Deviation 1.972
|
12.47 score on a scale
Standard Deviation 1.700
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Mother - T3
|
12.21 score on a scale
Standard Deviation 2.119
|
12.38 score on a scale
Standard Deviation 1.446
|
13.50 score on a scale
Standard Deviation 2.680
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Mother - T4
|
12.80 score on a scale
Standard Deviation 1.814
|
14.00 score on a scale
Standard Deviation 2.449
|
14.00 score on a scale
Standard Deviation 1,673
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Mother - T5
|
13.86 score on a scale
Standard Deviation 1.464
|
13.22 score on a scale
Standard Deviation 1.787
|
16.25 score on a scale
Standard Deviation 1.258
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Father - T1
|
11.80 score on a scale
Standard Deviation 2.331
|
12.94 score on a scale
Standard Deviation 2.358
|
12.35 score on a scale
Standard Deviation 2.290
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Father - T3
|
12.15 score on a scale
Standard Deviation 2.478
|
13.85 score on a scale
Standard Deviation 2.478
|
12.92 score on a scale
Standard Deviation 1.676
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Father - T4
|
12.50 score on a scale
Standard Deviation 2.224
|
14.00 score on a scale
Standard Deviation 2.404
|
12.82 score on a scale
Standard Deviation 2.136
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Adolescent - T1
|
11.37 score on a scale
Standard Deviation 2.712
|
11.65 score on a scale
Standard Deviation 1.693
|
10.35 score on a scale
Standard Deviation 2.737
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Adolescent - T3
|
11.33 score on a scale
Standard Deviation 2.229
|
11.54 score on a scale
Standard Deviation 1.808
|
11.00 score on a scale
Standard Deviation 2.793
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Adolescent - T4
|
13.22 score on a scale
Standard Deviation 1.856
|
12.20 score on a scale
Standard Deviation 2.044
|
11.27 score on a scale
Standard Deviation 1.902
|
|
Change in Cognitive Flexibility - Sorting Test Description of DKEFS
Adolescent - T5
|
12.171 score on a scale
Standard Deviation .488
|
12.00 score on a scale
Standard Deviation 2.582
|
11.17 score on a scale
Standard Deviation 2.483
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: All available data is reported for mothers, fathers and adolescents separately. Some data is missing due to COVID-19 impacts on the ability to administer in-person assessment.
The Behavior Rating Inventory of Executive Functioning (BRIEF) is an ecologically valid clinical tool for measuring executive functioning across several domains in youth 5 to 18 years of age; the self-report version (BRIEF-2) was administered to adolescents. It has a comparable adult self-report version (BRIEF-A) normed for ages 18-90. Both versions of the BRIEF are normed by age and sex on a T-scale (mean = 50, SD = 10), and scores are considered clinically elevated if they are 65 or higher. Both have a number of clinical scales and indices. Lower scores indicate greater strengths in each area. The hypothesis is that Cognitive Remediation Therapy (CRT) will increase flexibility in participants, thus, we expect a reduction in scores for those in the CRT conditions. The BRIEF was administered at baseline (T1), after 4 weeks (T2), approximately 9 weeks (T3), approximately 17 weeks (T4), and end of treatment (T5). The BRIEF Shift assesses behavioral flexibility.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=63 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Change in Self-Reported Shifting - BRIEF
Adolescent - T1
|
60.86 score on a scale
Standard Deviation 9.926
|
55.58 score on a scale
Standard Deviation 12.389
|
58.16 score on a scale
Standard Deviation 10.399
|
|
Change in Self-Reported Shifting - BRIEF
Mother - T1
|
58.38 score on a scale
Standard Deviation 6.953
|
53.21 score on a scale
Standard Deviation 7.843
|
51.79 score on a scale
Standard Deviation 9.920
|
|
Change in Self-Reported Shifting - BRIEF
Mother - T3
|
56.47 score on a scale
Standard Deviation 8.650
|
56.31 score on a scale
Standard Deviation 11.001
|
54.28 score on a scale
Standard Deviation 11.509
|
|
Change in Self-Reported Shifting - BRIEF
Mother - T4
|
56.07 score on a scale
Standard Deviation 9.996
|
55.75 score on a scale
Standard Deviation 12.557
|
52.94 score on a scale
Standard Deviation 11.771
|
|
Change in Self-Reported Shifting - BRIEF
Mother - T5
|
55.92 score on a scale
Standard Deviation 8.361
|
55.67 score on a scale
Standard Deviation 12.210
|
53.27 score on a scale
Standard Deviation 11.823
|
|
Change in Self-Reported Shifting - BRIEF
Father - T1
|
50.67 score on a scale
Standard Deviation 11.625
|
59.58 score on a scale
Standard Deviation 9.924
|
53.43 score on a scale
Standard Deviation 9.300
|
|
Change in Self-Reported Shifting - BRIEF
Father - T3
|
52.17 score on a scale
Standard Deviation 11.658
|
59.69 score on a scale
Standard Deviation 8.592
|
46.63 score on a scale
Standard Deviation 7.940
|
|
Change in Self-Reported Shifting - BRIEF
Father - T4
|
50.71 score on a scale
Standard Deviation 9.980
|
59.25 score on a scale
Standard Deviation 8.993
|
47.25 score on a scale
Standard Deviation 8.103
|
|
Change in Self-Reported Shifting - BRIEF
Father - T5
|
47.55 score on a scale
Standard Deviation 7.381
|
57.13 score on a scale
Standard Deviation 10.453
|
48.07 score on a scale
Standard Deviation 8.681
|
|
Change in Self-Reported Shifting - BRIEF
Adolescent - T3
|
58.71 score on a scale
Standard Deviation 12.494
|
55.13 score on a scale
Standard Deviation 11.618
|
55.59 score on a scale
Standard Deviation 11.571
|
|
Change in Self-Reported Shifting - BRIEF
Adolescent - T4
|
60.36 score on a scale
Standard Deviation 12.125
|
52.50 score on a scale
Standard Deviation 11.770
|
54.82 score on a scale
Standard Deviation 12.812
|
|
Change in Self-Reported Shifting - BRIEF
Adolescent - T5
|
58.18 score on a scale
Standard Deviation 10.226
|
50.38 score on a scale
Standard Deviation 9.726
|
54.87 score on a scale
Standard Deviation 10.789
|
PRIMARY outcome
Timeframe: 6 months of treatmentPopulation: As parents did not hit a-priori milestones, we only calculated the number (count) of sessions needed for adolescents to have measurable improvement in cognitive flexibility.
Number of sessions necessary in order to change cognitive flexibility. This is the number of sessions needed for change to occur in cognitive flexibility. It is only calculated for the participants who received CRT and who had a significant change in flexibility above what was observed in FBT.
Outcome measures
| Measure |
Family Based Treatment (FBT)
n=21 Participants
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=19 Participants
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
|---|---|---|---|
|
Dose of CRT
|
0 Number of sessions
|
—
|
8 Number of sessions
|
Adverse Events
Family Based Treatment (FBT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FBT w/ Parent-focused Cognitive Remediation Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
FBT w/Adolescent-focused Cognitive Remediation Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Family Based Treatment (FBT)
n=63 participants at risk
Families will receive 15 sessions of FBT alone.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/ Parent-focused Cognitive Remediation Therapy
n=57 participants at risk
Family Based Treatment with Parent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of parent focused CRT followed Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
|
FBT w/Adolescent-focused Cognitive Remediation Therapy
n=57 participants at risk
Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of adolescent focused CRT followed by Family Based Treatment over six months.
Cognitive Remediation Therapy: Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
Family Based Treatment: Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
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Cardiac disorders
Other
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0.00%
0/63 • 6 months (from baseline intake to end of treatment)
Definitions used for adverse events are the same as those used by clinicaltrials.gov.
|
1.8%
1/57 • Number of events 1 • 6 months (from baseline intake to end of treatment)
Definitions used for adverse events are the same as those used by clinicaltrials.gov.
|
0.00%
0/57 • 6 months (from baseline intake to end of treatment)
Definitions used for adverse events are the same as those used by clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place